Cerbomed GmbH: transcutaneous Vagus Nerve Stimulation for pain relief

Published: August 23, 2012

Read more here: http://www.heraldonline.com/2012/08/23/4208412/cerbomed-gmbh-transcutaneous-vagus.html#storylink=cpy

ERLANGEN, Germany — The medical device company cerbomed GmbH from Erlangen, Germany has received the European clearance (CE mark) for the application of transcutaneous Vagus Nerve Stimulation (t-VNS) in pain relief therapy.

Pain-relieving effect of t-VNS
A randomized study on pain processing was conducted in cooperation with the university of Regensburg in 2011. With t-VNS, there was a significant reduction of perceived mechanical pain in healthy volunteers (Busch et al., Brain Stimulation, in press).

In a second randomized controlled study, pain processing in the right and left hand was examined on 49 healthy volunteers on three different days. The effect of a dextral t-VNS after stimulation of the left ear was also examined for the first time. In both cases, t-VNS reduced pain perception following mechanical stimuli significantly.

“The current results and literature data form the foundation of the clinical study on the effect of t-VNS in chronic migraine treatment. It is conducted by the Headache Center of the Neurological Department at the Großhadern Hospital in Munich”, explains Prof. Dr. Jens Ellrich, Chief Medical Officer of cerbomed GmbH. The randomized controlled study is examining the efficacy of t-VNS on 98 patients suffering from chronic migraine.

From August 27th to 31st, cerbomed will be presenting t-VNS to an expert audience at the 14th World Congress on Pain in Milan, which is organized by the International Association for the Study of Pain.

About t-VNS
Transcutaneous Vagus Nerve Stimulation is addressed to patients suffering from various difficult to treat neurological and psychiatric diseases. The t-VNS therapy uses the fact that a branch of the vagus nerve is located directly under the skin in areas of the outer ear and therefore can be stimulated through the skin (transcutaneously) with electrical impulses.

About cerbomed
Cerbomed is an innovative medical device company located in Erlangen, Germany, that focuses on neuromodulation. The company, founded in 2005, focuses on transcutaneous Vagus Nerve Stimulation (t-VNS), which may offer an attractive therapy option for patients with hard-to-treat neurological and psychiatric illnesses.

Find out more about cerbomed at www.cerbomed.com

http://www.heraldonline.com/2012/08/23/4208412/cerbomed-gmbh-transcutaneous-vagus.html

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Biol Mood Anxiety Disord. 2012 Aug 17;2(1):14. [Epub ahead of print]

Somatic therapies for treatment-resistant depression: ECT, TMS, VNS, DBS.

Cusin C, Dougherty DD.

Abstract

ABSTRACT: The field of non-pharmacological therapies for treatment resistant depression (TRD) is rapidly evolving and new somatic therapies are valuable options for patients who have failed numerous other treatments. A major challenge for clinicians (and patients alike) is how to integrate the results from published clinical trials in the clinical decision-making process.We reviewed the literature for articles reporting results for clinical trials in particular efficacy data, contraindications and side effects of somatic therapies including electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), vagal nerve stimulation (VNS) and deep brain stimulation (DBS). Each of these devices has an indication for patients with different level of treatment resistance, based on acuteness of illness, likelihood of response, costs and associated risks. ECT is widely available and its effects are relatively rapid in severe TRD, but its cognitive adverse effects may be cumbersome. TMS is safe and well tolerated, and it has been approved by FDA for adults who have failed to respond to one antidepressant, but its use in TRD is still controversial as it is not supported by rigorous double-blind randomized clinical trials. The options requiring surgical approach are VNS and DBS. VNS has been FDA-approved for TRD, however it is not indicated for management of acute illness. DBS for TRD is still an experimental area of investigation and double-blind clinical trials are underway.

PMID:

22901565

[PubMed - as supplied by publisher]

http://www.ncbi.nlm.nih.gov/pubmed/22901565

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• Review Treatment resistant depression--advances in somatic therapies.[Ann Clin Psychiatry. 2007]
  Review Treatment resistant depression--advances in somatic therapies.

  Kennedy SH, Giacobbe P. Ann Clin Psychiatry. 2007 Oct-Dec; 19(4):279-87.
• Review Therapeutic options for treatment-resistant depression.[CNS Drugs. 2010]
  Review Therapeutic options for treatment-resistant depression.

  Shelton RC, Osuntokun O, Heinloth AN, Corya SA. CNS Drugs. 2010 Feb; 24(2):131-61.
• Review The application of vagus nerve stimulation and deep brain stimulation in depression.[Neuropsychobiology. 2011]
  Review The application of vagus nerve stimulation and deep brain stimulation in depression.

  Mohr P, Rodriguez M, Slavíčková A, Hanka J. Neuropsychobiology. 2011; 64(3):170-81. Epub 2011 Jul 29.
• Vagus Nerve Stimulation (VNS) and Treatment of Depression: To the Brainstem and Beyond.[Psychiatry (Edgmont). 2006]
  Vagus Nerve Stimulation (VNS) and Treatment of Depression: To the Brainstem and Beyond.

  O'Reardon JP, Cristancho P, Peshek AD. Psychiatry (Edgmont). 2006 May; 3(5):54-63.
• Review Nonpharmacological, somatic treatments of depression: electroconvulsive therapy and novel brain stimulation modalities.[Dialogues Clin Neurosci. 2006]
  Review Nonpharmacological, somatic treatments of depression: electroconvulsive therapy and novel brain stimulation modalities.

  Eitan R, Lerer B. Dialogues Clin Neurosci. 2006; 8(2):241-58.

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J Pharmacol Exp Ther. 2012 May;341(2):317-25. Epub 2012 Jan 27.

Comparison of ΔFosB immunoreactivity induced by vagal nerve stimulation with that caused by pharmacologically diverse antidepressants.

Furmaga H, Sadhu M, Frazer A.

Source

Department of Pharmacology, the University of Texas Health Science Center, San Antonio, Texas, USA.

Abstract

Vagal nerve stimulation (VNS) has been approved for treatment of refractory depression. However, there have been few, if any, studies directly comparing the effects produced by VNS in animals with those caused by antidepressants, particularly using clinically relevant stimulation parameters in nonanesthetized animals. In this study, ΔFosB immunohistochemistry was used to evaluate different brain regions activated by long-term administration of VNS. Effects of VNS were compared with those caused by sertraline or desipramine (DMI). Double-labeling of ΔFosB and serotonin was used to determine whether serotonergic neurons in the dorsal raphe nucleus (DRN) were activated by long-term VNS. VNS significantly increased ΔFosB staining in the nucleus tractus solitarius (NTS), parabrachial nucleus (PBN), locus ceruleus (LC), and DRN, as well as in many cortical and limbic areas of brain including those involved in mood and cognition. Most, but not all, of these effects were seen also upon long-term treatments of rats with sertraline or DMI. Some areas where VNS increased ΔFosB (e.g., the NTS, PBN, LC, and peripeduncular nucleus) were not affected significantly by either drug. Sertraline was similar to VNS in causing an increase in the DRN whereas DMI did not. Double-labeling of the DRN with ΔFosB and an antibody for serotonin revealed that only a small percentage of ΔFosB staining in the DRN colocalized with serotonergic neurons. The effects of VNS were somewhat more widespread than those caused by the antidepressants. The increases in ΔFosB produced by VNS were either equivalent to and/or more robust than those seen with antidepressants.

PMID:

22286499

[PubMed - indexed for MEDLINE]

PMCID:

PMC3336814

[Available on 2013/5/1]

http://www.ncbi.nlm.nih.gov/pubmed/22286499

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• Induction of c-Fos and DeltaFosB immunoreactivity in rat brain by Vagal nerve stimulation.[Neuropsychopharmacology. 2008]
  Induction of c-Fos and DeltaFosB immunoreactivity in rat brain by Vagal nerve stimulation.

  Cunningham JT, Mifflin SW, Gould GG, Frazer A. Neuropsychopharmacology. 2008 Jul; 33(8):1884-95. Epub 2007 Oct 24.
• Serotonergic and noradrenergic pathways are required for the anxiolytic-like and antidepressant-like behavioral effects of repeated vagal nerve stimulation in rats.[Biol Psychiatry. 2011]
  Serotonergic and noradrenergic pathways are required for the anxiolytic-like and antidepressant-like behavioral effects of repeated vagal nerve stimulation in rats.

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• Effect of vagus nerve stimulation on serotonergic and noradrenergic transmission.[J Pharmacol Exp Ther. 2006]
  Effect of vagus nerve stimulation on serotonergic and noradrenergic transmission.

  Dorr AE, Debonnel G. J Pharmacol Exp Ther. 2006 Aug; 318(2):890-8. Epub 2006 May 11.
• Review VNS therapy in treatment-resistant depression: clinical evidence and putative neurobiological mechanisms.[Neuropsychopharmacology. 2006]
  Review VNS therapy in treatment-resistant depression: clinical evidence and putative neurobiological mechanisms.

  Nemeroff CB, Mayberg HS, Krahl SE, McNamara J, Frazer A, Henry TR, George MS, Charney DS, Brannan SK. Neuropsychopharmacology. 2006 Jul; 31(7):1345-55. Epub 2006 Apr 19.
• Review The application of vagus nerve stimulation and deep brain stimulation in depression.[Neuropsychobiology. 2011]
  Review The application of vagus nerve stimulation and deep brain stimulation in depression.

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See reviews...See all...

 

Wayne McCourt receives a TMS treatment for depression. / JOSE F. MORENO/Courier-Post

Treatment may help some with depression

10:56 PM, Aug. 18, 2012

Written by

Christina Mitchell

Courier-Post Staff

One psychiatrist calls TMS therapy a “revolutionary” treatment for depression. Another is more cautious, calling it “welcome.”

Joanne Malia says transcranial magnetic stimulation is a “miracle.”

The 70-year-old Williamstown resident lost three of her four grown children — sons Jimmy, Jeffrey and Joel Malia — in a 2002 speedboat accident. By the time Malia found out about TMS last June, she had been crippled by depression for several years.

“I could not function,” recalls the owner of Malia Auto Body. “I was even told that I drug my feet at work. I wasn’t a help to anyone. I was more of a hindrance.”

About 12 weeks into treatment with Dr. Edward Baruch at TMS Centers of Southern New Jersey in Mount Laurel, “little things” began to change, Malia recalls.

“I would always leave dishes in the sink. And I noticed one day that I did the dishes right away. And I was happy because I like things to be neat. And I was able to talk about the boys … the funny things they did or said.

“Up to that point, I didn’t see anything funny,” she said.

Word is spreading about TMS, which uses MRI-like magnetic pulses of energy to stimulate nerve cells in the right side of the brain that affect mood. Each procedure lasts about 45 minutes and can be done in a doctor’s office. There are no drugs or surgery and side effects are minimal.

Too good to be true? If you’ve lived in the black hole of depression, the answer is no.

“No treatment or toolbox solves the problem of depression completely,” says Dr. John O’Reardon, a primary TMS researcher and chairman of Stratford’s University of Medicine & Dentistry of New Jersey-School of Osteopathic Medicine. But for patients with acute depression, TMS has impressive results, O’Reardon adds.

The Malvern, Pa.-based company Neuronetics was FDA-approved in 2008 to market the treatment under Neurostar TMS Therapy for adults who fail to benefit from antidepressant medication, currently the sole U.S. company licensed to do so.

Baruch invested $70,000 in a TMS machine last May. So far, he says, he has treated about 20 people at a cost of $350 per session. The recommended course of treatment is five times a week for four to six weeks.

“People are starting to wake up to the treatment,” says Baruch (pronounced bar-OOK). “It’s a truly revolutionary treatment for depression that’s not been available before, with extremely limited side effects.”

Baruch says some TMS patients may initially experience mild headaches and scalp irritation from the procedure. Other patients have likened its sensation to a woodpecker tapping on the skull.

While TMS still is largely unknown, it is showing up in medical journals and the media. It got the ultimate endorsement in March from the nation’s favorite TV doctor, cardiac surgeon Mehmet Oz. About 400 centers perform the procedure nationally.

“This is an awakening,” says Baruch, one of a handful of TMS practitioners in South Jersey. “It’s basically introducing an unknown treatment for a community for which this is novel.”

But that community does not encompass everyone with depression. TMS is FDA-approved only for patients who have not responded to medication, or about 30 percent of depression sufferers, explains O’Reardon.

For that group, invasive ECT (electroconvulsive therapy) is often a last resort because it can cause short- and long-term memory loss and requires an electrical current. TMS increases blood flow to a targeted area of the brain with magnetic pulses weaker than the standard MRI.

A study published in 2010 in the journal Brain Stimulation showed long-term relief from TMS, according to the AARP Bulletin. Only 13 percent of those who responded to treatment relapsed after six months, the study showed.

The American Psychiatric Association has included TMS in its practice guidelines. A study funded in 2010 by the National Institutes of Mental Health showed TMS was effective in some patients not responsive to traditional treatments.

“(TMS) is for patients who have not responded to several trials of antidepressant medications in a current episode and where it’s safe for TMS,” explains O’Reardon.

Because it utilizes MRI technology, the treatment is prohibited for anyone with metal implants or a history of epilepsy.

“It’s the first device we have that stimulates the brain, in a doctor’s office, to treat depression, and doesn’t involve medication,” O’Reardon adds.

“It gets a person out of the deep hole.”

But he cautions TMS doesn’t negate the benefits of traditional cognitive (talk) therapy or medications, and some patients may require follow-up sessions after the recommended 25- to 30-session treatment.

Yet for those who endure depression drug side effects — weight gain, sexual dysfunction, lethargy — without benefit, TMS is an enticing prospect. The only downside is cost. A round of TMS treatment can cost anywhere between $6,000 and $11,000, according to Neuronetics, and is currently not reimbursable by Medicare or private insurance in New Jersey.

That could change soon. Medicare now reimburses for TMS in every New England state except Connecticut, according to Neuronetics spokesman Mike Gaynes. Anthem Blue Cross/Blue Shield quietly announced this week it would cover the procedure in 14 states ranging from Connecticut to Georgia.

And at least one pharmaceutical company isn’t adverse to TMS as an ancillary to profitable depression medications.

“Things are changing for sure,” says Suzanne McMonigle of Neuronetics, which recently got $30 million in financing raised in part by Pfizer Pharmaceuticals to expand abroad. Pfizer produces Zoloft, among other antidepressants.

“It’s estimated there are about four million people nationwide who do not respond to medication,” she adds. “That would make pharmaceutical companies start to look outside for other treatment modalities.

“Somebody needs to treat those folks.”

“The great treatments in medicine are the ones that encompass as many aspects of healing as possible,” observes Baruch. “This is truly the best, most revolutionary treatment for psychiatric disorder I have ever seen in my life.

“And I’ve been in mental health for over 35 years.”

Reach Christina Mitchell at (856) 486-2442 or chmitchell@gannett.com

http://www.courierpostonline.com/article/20120819/NEWS01/308190015/Treatment-may-help-some-depression

Eur J Neurol. 2012 Sep;19(9):1219-1223. doi: 10.1111/j.1468-1331.2012.03707.x. Epub 2012 Mar 26.

Successful outcome of episodes of status epilepticus after vagus nerve stimulation: a multicenter study.

Sierra-Marcos A, Maestro I, Rodríguez-Osorio X, Miró J, Donaire A, Aparicio J, Rumiá J, Forcadas M, Garamendi I, Pardo J, López J, Prieto A, Plans G, Falip M, Carreño M.

Source

Neurology Department, Hospital Clínic, Barcelona Neurophysiology Department, Hospital de Cruces, Bilbao Neurology Department, Complejo Hospitalario Universitario de Santiago de Compostela Neurology Department, Hospital Bellvitge, Barcelona Neurosurgery Department, Hospital Clínic, Barcelona Neurology Department, Hospital de Cruces, Bilbao Neurosurgery Department, Complejo Hospitalario Universitario de Santiago de Compostela Neurosurgery Department, Hospital Bellvitge, Barcelona, Spain.

Abstract

Background and purpose:  Vagus nerve stimulation (VNS) has been reported to be a safe and effective treatment for drug-resistant epilepsy. The aim of this study is to describe the effect of VNS in patients with a history of repeated episodes of status epilepticus (SE) before implantation. Methods:  From a total of 83 adult patients with drug-resistant epilepsy who had VNS implanted in four tertiary centers in Spain between 2000 and 2010, eight had a previous history of repeated episodes of SE. We performed a retrospective observational study analyzing the outcome of seizures and episodes of SE after implantation. Stimulation was started at the usual settings, and intensity increased according to clinical response and tolerability. Results:  Regarding the eight patients with a history of SE, the mean age at time of VNS implantation was 25.1 [14-40] years. Duration of epilepsy until the implantation was 21.7 [7-39.5] years, and they had been treated with a mean of 12 antiepileptic drugs [10-16]. Mean follow-up since implantation was 4.15 [2-7.5] years. Average seizure frequency decreased from 46 to 8.2 per month. Interestingly, four of the eight patients remained free of new episodes of SE after implantation, and in two additional patients, the frequency decreased by >75%. Adverse effects were mild or moderate in intensity and included mainly coughing and dysphonia. Conclusion:  In those patients with refractory epilepsy and history of SE who are not surgical candidates, VNS is a safe and effective method to reduce seizure frequency and episodes of SE.
© 2012 The Author(s). European Journal of Neurology © 2012 EFNS.

PMID:

22891774

[PubMed - as supplied by publisher]

http://www.ncbi.nlm.nih.gov/pubmed/22891774

Related citations in PubMed

• Vagus nerve stimulation for refractory epilepsy: a Belgian multicenter study.[Eur J Paediatr Neurol. 2007]
  Vagus nerve stimulation for refractory epilepsy: a Belgian multicenter study.

  De Herdt V, Boon P, Ceulemans B, Hauman H, Lagae L, Legros B, Sadzot B, Van Bogaert P, van Rijckevorsel K, Verhelst H, et al. Eur J Paediatr Neurol. 2007 Sep; 11(5):261-9. Epub 2007 Mar 28.
• Vagus nerve stimulation for medically refractory epilepsy; efficacy and cost-benefit analysis.[Acta Neurochir (Wien). 1999]
  Vagus nerve stimulation for medically refractory epilepsy; efficacy and cost-benefit analysis.

  Boon P, Vonck K, Vandekerckhove T, D'have M, Nieuwenhuis L, Michielsen G, Vanbelleghem H, Goethals I, Caemaert J, Calliauw L, et al. Acta Neurochir (Wien). 1999; 141(5):447-52; discussion 453.
• Vagus nerve stimulation for medically refractory epilepsy: a long-term follow-up study.[Seizure. 2007]
  Vagus nerve stimulation for medically refractory epilepsy: a long-term follow-up study.

  Ardesch JJ, Buschman HP, Wagener-Schimmel LJ, van der Aa HE, Hageman G. Seizure. 2007 Oct; 16(7):579-85. Epub 2007 May 31.
• Review Vagal nerve stimulation for refractory epilepsy in children: indications and experience at The Hospital for Sick Children.[Childs Nerv Syst. 2006]
  Review Vagal nerve stimulation for refractory epilepsy in children: indications and experience at The Hospital for Sick Children.

  Benifla M, Rutka JT, Logan W, Donner EJ. Childs Nerv Syst. 2006 Aug; 22(8):1018-26. Epub 2006 Jul 1.
• Review An institutional experience with cervical vagus nerve trunk stimulation for medically refractory epilepsy: rationale, technique, and outcome.[Neurosurgery. 1998]
  Review An institutional experience with cervical vagus nerve trunk stimulation for medically refractory epilepsy: rationale, technique, and outcome.

  Amar AP, Heck CN, Levy ML, Smith T, DeGiorgio CM, Oviedo S, Apuzzo ML. Neurosurgery. 1998 Dec; 43(6):1265-76; discussion 1276-80.

See reviews...See all...

Front Psychiatry. 2012;3:70. Epub 2012 Aug 7.

Transcutaneous Vagus Nerve Stimulation: Retrospective Assessment of Cardiac Safety in a Pilot Study.

Kreuzer PM, Landgrebe M, Husser O, Resch M, Schecklmann M, Geisreiter F, Poeppl TB, Prasser SJ, Hajak G, Langguth B.

Source

Department of Psychiatry and Psychotherapy, University of Regensburg Regensburg, Germany.

Abstract

Background: Vagus nerve stimulation has been successfully used as a treatment strategy for epilepsy and affective disorders for years. Transcutaneous vagus nerve stimulation (tVNS) is a new non-invasive method to stimulate the vagus nerve, which has been shown to modulate neuronal activity in distinct brain areas. Objectives: Here we report effects of tVNS on cardiac function from a pilot study, which was conducted to evaluate the feasibility and safety of tVNS for the treatment of chronic tinnitus. Methods: Twenty-four patients with chronic tinnitus underwent treatment with tVNS over 3-10 weeks in an open single-armed pilot study. Safety criteria and practical usability of the neurostimulating device were to investigate by clinical examination and electrocardiography at baseline and at several visits during and after tVNS treatment (week 2, 4, 8, 16, and 24). Results: Two adverse cardiac events (one classified as a severe adverse event) were registered but considered very unlikely to have been caused by the tVNS device. Retrospective analyses of electrocardiographic parameters revealed a trend toward shortening of the QRS complex after tVNS. Conclusion: To our knowledge this is one of the first studies investigating feasibility and safety of tVNS in a clinical sample. In those subjects with no known pre-existing cardiac pathology, preliminary data do not indicate arrhythmic effects of tVNS.

PMID:

22891061

[PubMed - as supplied by publisher]

http://www.ncbi.nlm.nih.gov/pubmed/22891061

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• [A novel transcutaneous vagus nerve stimulation leads to brainstem and cerebral activations measured by functional MRI].[Biomed Tech (Berl). 2008]
  [A novel transcutaneous vagus nerve stimulation leads to brainstem and cerebral activations measured by functional MRI].

  Dietrich S, Smith J, Scherzinger C, Hofmann-Preiss K, Freitag T, Eisenkolb A, Ringler R. Biomed Tech (Berl). 2008 Jun; 53(3):104-11.
• Final Report on Carcinogens Background Document for Formaldehyde.[Rep Carcinog Backgr Doc. 2010]
  Final Report on Carcinogens Background Document for Formaldehyde.

  National Toxicology Program. Rep Carcinog Backgr Doc. 2010 Jan; (10-5981):i-512.
• Therapy of unspecific tinnitus without organic cause.[GMS Health Technol Assess. 2006]
  Therapy of unspecific tinnitus without organic cause.

  Frank W, Konta B, Seiler G. GMS Health Technol Assess. 2006 Aug 30; 2:Doc17. Epub 2006 Aug 30.
• Review An institutional experience with cervical vagus nerve trunk stimulation for medically refractory epilepsy: rationale, technique, and outcome.[Neurosurgery. 1998]
  Review An institutional experience with cervical vagus nerve trunk stimulation for medically refractory epilepsy: rationale, technique, and outcome.

  Amar AP, Heck CN, Levy ML, Smith T, DeGiorgio CM, Oviedo S, Apuzzo ML. Neurosurgery. 1998 Dec; 43(6):1265-76; discussion 1276-80.
• Review Modern management of epilepsy: Vagus nerve stimulation.[Baillieres Clin Neurol. 1996]
  Review Modern management of epilepsy: Vagus nerve stimulation.

  Ben-Menachem E. Baillieres Clin Neurol. 1996 Dec; 5(4):841-8.

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Neurosurgery. 2011 Nov;69(5):E1172-5.

Refractory status epilepticus treated with vagal nerve stimulation: case report.

O'Neill BR, Valeriano J, Synowiec A, Thielmann D, Lane C, Wilberger J.

Source

Department of Neurosurgery, University of Colorado, Aurora, Colorado 80045, USA. boneill35@gmail.com

Abstract

BACKGROUND AND IMPORTANCE:

Status epilepticus (SE) refractory to medical treatment has a high mortality rate and few effective treatments.

CLINICAL PRESENTATION:

We describe the implantation of a vagal nerve stimulator to help terminate a case of refractory SE. A 23-year-old man was in SE for 3 weeks without being able to be weaned from intravenous anesthetic agents. After implantation of a vagal nerve stimulator, SE soon terminated, and the patient could be weaned from sedative agents and made a full recovery.

CONCLUSION:

Vagal nerve stimulator should be considered in cases of refractory SE.

PMID:

21577172

[PubMed - indexed for MEDLINE]

http://www.ncbi.nlm.nih.gov/pubmed/21577172

Related citations in PubMed

• Control of refractory status epilepticus precipitated by anticonvulsant withdrawal using left vagal nerve stimulation: a case report.[Surg Neurol. 2005]
  Control of refractory status epilepticus precipitated by anticonvulsant withdrawal using left vagal nerve stimulation: a case report.

  Patwardhan RV, Dellabadia J Jr, Rashidi M, Grier L, Nanda A. Surg Neurol. 2005 Aug; 64(2):170-3.
• Vagus nerve stimulation for refractory status epilepticus.[Eur J Paediatr Neurol. 2009]
  Vagus nerve stimulation for refractory status epilepticus.

  De Herdt V, Waterschoot L, Vonck K, Dermaut B, Verhelst H, Van Coster R, De Jaeger A, Van Roost D, Boon P. Eur J Paediatr Neurol. 2009 May; 13(3):286-9. Epub 2008 Jun 27.
• Vagal nerve stimulator use during pregnancy for treatment of refractory seizure disorder.[Obstet Gynecol. 2010]
  Vagal nerve stimulator use during pregnancy for treatment of refractory seizure disorder.

  Houser MV, Hennessy MD, Howard BC. Obstet Gynecol. 2010 Feb; 115(2 Pt 2):417-9.
• Review Which anesthetic should be used in the treatment of refractory status epilepticus?[Epilepsia. 2007]
  Review Which anesthetic should be used in the treatment of refractory status epilepticus?

  Rossetti AO. Epilepsia. 2007; 48 Suppl 8:52-5.
• Review Novel anesthetics and other treatment strategies for refractory status epilepticus.[Epilepsia. 2009]
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  Rossetti AO. Epilepsia. 2009 Dec; 50 Suppl 12:51-3.

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Eur J Paediatr Neurol. 2012 Aug 6. [Epub ahead of print]

Behavioural and cognitive effects during vagus nerve stimulation in children with intractable epilepsy - A randomized controlled trial.

Klinkenberg S, van den Bosch CN, Majoie HJ, Aalbers MW, Leenen L, Hendriksen J, Cornips EM, Rijkers K, Vles JS, Aldenkamp AP.

Source

Department of Neurology, Maastricht University Medical Center, P.O. Box 5800, 6202 AZ Maastricht, The Netherlands.

Abstract

BACKGROUND/AIMS:

In addition to effects on seizure frequency in intractable epilepsy, multiple studies report benefits of vagus nerve stimulation (VNS) on behavioural outcomes and quality of life. The present study aims to investigate the effects of VNS on cognition, mood in general, depression, epilepsy-related restrictions and psychosocial adjustment in children with intractable epilepsy, as well as the relation between these effects and seizure reduction.

METHODS:

We conducted a randomized, active-controlled, double-blinded, add-on study in 41 children (age 4-18) with medically refractory epilepsy. We performed cognitive and behavioural testing at baseline (12 weeks), at the end of the blinded phase (20 weeks) in children receiving either high-output or low-output (active control) stimulation, and at the end of the open label phase (19 weeks) with all children receiving high-output stimulation. Seizure frequency was recorded using seizure diaries.

RESULTS:

VNS did not have a negative effect on cognition nor on psychosocial adjustment. At the end of the follow-up phase we noted an improvement of mood in general and the depression subscale for the entire group, unrelated to a reduction of seizure frequency. At the end of the blinded phase a ≥50% reduction of seizure frequency occurred in 16% of the high-stimulation group and 21% of the low-stimulation group. At the end of the open-label follow-up phase, 26% of the children experienced a seizure frequency reduction of 50% or more (responders).

CONCLUSIONS:

VNS has additional beneficial effects in children with intractable epilepsy. As opposed to anti-epileptic drugs, there are no negative effects on cognition. Moreover, we observed an improvement of mood in general and depressed feelings in particular, irrespective of a reduction in seizure frequency. These beneficial effects should be taken into account when deciding whether to initiate or continue VNS treatment in these children.
Copyright © 2012. Published by Elsevier Ltd.

PMID:

22878130

[PubMed - as supplied by publisher]

http://www.ncbi.nlm.nih.gov/pubmed/22878130

Related citations in PubMed

• Vagus nerve stimulation in children with intractable epilepsy: a randomized controlled trial.[Dev Med Child Neurol. 2012]
  Vagus nerve stimulation in children with intractable epilepsy: a randomized controlled trial.

  Klinkenberg S, Aalbers MW, Vles JS, Cornips EM, Rijkers K, Leenen L, Kessels FG, Aldenkamp AP, Majoie M. Dev Med Child Neurol. 2012 Apr 28; . Epub 2012 Apr 28.
• Vagus nerve stimulation in 15 children with therapy resistant epilepsy; its impact on cognition, quality of life, behaviour and mood.[Seizure. 2005]
  Vagus nerve stimulation in 15 children with therapy resistant epilepsy; its impact on cognition, quality of life, behaviour and mood.

  Hallböök T, Lundgren J, Stjernqvist K, Blennow G, Strömblad LG, Rosén I. Seizure. 2005 Oct; 14(7):504-13. Epub 2005 Sep 19.
• Short-term Results of Vagus Nerve Stimulation in Pediatric Patients with Refractory Epilepsy.[Pediatr Neonatol. 2012]
  Short-term Results of Vagus Nerve Stimulation in Pediatric Patients with Refractory Epilepsy.

  Chen CY, Lee HT, Chen CC, Kwan SY, Chen SJ, Hsieh LP, Tsai JD, Taiwan Child Neurology Society VNS Study Group. Pediatr Neonatol. 2012 Jun; 53(3):184-7. Epub 2012 Jun 5.
• Review Vagus nerve stimulation for epilepsy: a meta-analysis of efficacy and predictors of response.[J Neurosurg. 2011]
  Review Vagus nerve stimulation for epilepsy: a meta-analysis of efficacy and predictors of response.

  Englot DJ, Chang EF, Auguste KI. J Neurosurg. 2011 Dec; 115(6):1248-55. Epub 2011 Aug 12.
• Review Vagus nerve stimulation for seizures.[Arch Med Res. 2000]
  Review Vagus nerve stimulation for seizures.

  Uthman BM. Arch Med Res. 2000 May-Jun; 31(3):300-3.

See reviews...See all...

This story is taken from Sacbee /

Markets for Electrostimulation Devices (Neurostimulation, Cardiac Rhythm Management, Fracture Healing and Others)

Published Monday, Aug. 06, 2012

NEW YORK, Aug. 6, 2012 -- /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:
Markets for Electrostimulation Devices (Neurostimulation, Cardiac Rhythm Management, Fracture Healing and Others)
http://www.reportlinker.com/p0944033/Markets-for-Electrostimulation-Devices-Neurostimulation-Cardiac-Rhythm-Management-Fracture-Healing-and-Others.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Cardiovascular_Devices
Electrical and magnetic stimulation is the primary focus of this Kalorama Information Report. Rather than attempting to define and classify all of the varying electrostimulatory methods, this report groups technologies into basic categories based on application and complexity.
The audience for this report includes technical directors, business development managers, investors, and analysts who want a panoramic view, at a quantitative level, of the technology and medical applications of electrical and magnetic stimulation. This is a far-reaching field, and this report thus serves as a survey aimed at providing insight about the realm of market possibilities. Two general segments are discussed with various sub-segments included:
External Electrical Stimulation Devices:

• Bone Growth Simulation

• Transcutaneous Electrical Nerve Stimulation (TENS)

• Ultrasound-Accelerated Fracture Healing

Implanted Electrical Simulation Devices

• Bone Growth Stimulation

• Cardiac Resynchronization Therapy

• Deep Brain Stimulation

• Gastric Electrical Stimulation

• Implantable Cardiac Pacemakers

• ImplantableCardioverter-Defibrillators

• Sacral Nerve Stimulation

• Spinal Cord Stimulation

• Vagus Nerve Stimulation

Companies involved in the market are profiled to provide an understanding of today's competitive environment and marketing strategies.
Demand for both electrical and magnetic neurostimulationtechnologies is expected to grow moderately during the next few years.
TENS is commonly used for pain management.Despite controversy over the degree to which TENS is more effective than placebo in reducing pain, the market for TENS equipment continues to remain steady. Electromuscular stimulation (EMS) of muscle tissue can aid in the recuperation of overworked muscles. Technological progress continues in EMS,especially with microprocessors that allow protection against the risk of burning and elimination of electrical pain. Transcranial magnetic stimulation (TMS) is a non-invasive technique that uses an electromagnet placed on the patient's scalp to alter brain activity. Repetitive TMS (rTMS), which uses varying frequencies and intensities of magnetic fields, seems to have therapeutic value. During the previous years, rTMS has received a growing attention in the popular and scientific media. The market forecasts reflect growing professional medical acceptance. The demand of electrostimulation products based on external electrodes is expected to benefit from innovative developments in FES designed to augment movement of atrophied muscles, promote new nerve function, and provide interfaces between nerve cells and computing devices. The market for treating depression is one of the most promising applications of neurotechnology devices. The potential market opportunity is huge, with between over 20 million people in the U.S.alone who could potentially benefit.
A new group of active electrodes are underdevelopment. These can connect nerve cells to microcircuits and provide a living link between living tissues and hardware. Direct interfaces between small networks of nerve cells and microdevices are advancing the understanding of nerves and leading the way to a new generation of hybrid devices that communicate between computers and biological neural networks. There are several research teams in the U.S.and Europe that are currently working on so-called neural-silicon hybrid chips. Wireless technology could lead to the replacement of leads with small radios that can transmit and receive information and energy.
CHAPTER ONE: EXECUTIVE SUMMARY

• Electrostimulation and Neuroprosthetic Technology Introduction

• Scope of This Report

• A Strong Market Foundation

• Future Directions

• Market Size and Projections

CHAPTER TWO: INTRODUCTION TO ELECTROSTIMULATION AND RELATED TECHNOLOGIES

• Stimulation Therapeutics for Muscles and Nerves

• Medical Applications of External Electrode Modalities

• Electrical Stimulation

• Measurement and Diagnosis

• Stimulation by Magnetic Field Pulses

• Ultrasonic and Short Wavelength Diathermy

• Medical Applications of Implanted Electrode Modalities

• Bladder Stimulators

• Carotid Sinus Nerve Stimulation

• Cochlear Implant

• Deep Brain Stimulation

• Electrical Continence

• Electrical Nerve Stimulation

• Pelvic Floor Stimulation

• Phrenic Nerve Stimulation

• Sacral Nerve Stimulation

• Spinal Cord Stimulation

• Vagus Nerve Stimulation

• Characteristics of the Electrostimulation Market

• Market Segmentation of Neurostimulation Modalities

• Market Trends and Assumptions

• Competitive Landscape and Issues

• Applicable Industrial and Regulatory Codes

• Companies in the Electrostimulation Market

• End-User Segments

CHAPTER THREE : EXTERNAL ELECTRICAL STIMULATION DEVICES

• Introduction

• External Electrostimulation Technologies

• Bone Growth Stimulation

• Market Analysis

• EMS, NMS, TENS

• Transcutaneous Electrical Nerve Stimulation (TENS)

• Early Observations of Pain Relief

• Physiological Model Theories

• Interferential Current

• Galvanic Stimulation

• Electrodes

• Market Analysis

• Ultrasound-Accelerated Fracture Healing

• Market Analysis

• Other Treatments

• ECT

• TMS and rTMS

• Market Forecasts for Electrostimulation With External Electrodes

CHAPTER FOUR: IMPLANTED ELECTRICAL AND NEUROLOGICAL STIMULATION DEVICES

• Introduction

• Types of Implanted Electrode Systems

• Implanted Bone Growth Stimulators

• Market Analysis

• Cardiac Rhythm Management

• Cardiac Resynchronization Therapy

• Implantable Cardiac Pacemakers

• Implantable Cardioverter-Defibrillators

• Market Analysis

• Spinal Cord Stimulation (SCS)

• Basic Implementation

• SCS vs TENS in Pain Relief

• Cost-Benefit Analysis of SCS

• Market Analysis

• Sacral Nerve Stimulation (SNS)

• Control of Urinary Incontinence

• Control of Fecal Incontinence

• Market Analysis

• Vagus Nerve Stimulation (VNS)

• Seizure Control in Epilepsy

• Treatment of Depression

• Market Analysis

• Deep Brain Stimulation (DBS)

• Treatment of Neurological Movement Disorders

• Market Analysis

• Gastric Electrical Stimulation (GES)

• Market Analysis

• Market Analysis for Implanted Electrical and Neurological Stimulation Devices

CHAPTER FIVE: INDUSTRY TRENDS AND ISSUES

• New Innovations

• Brain Stimulation

• Obstructive Sleep Apnea

• Neurostim and Obesity

• Implantable Therapy for Resistant Hypertension

• Pain Therapy

• Epilepsy

• New Developments and Alternative Technologies

• Magnetic Stimulation

• Transcranial Magnetic Stimulation (TMS)

• Magnetic Stimulation and Depression Treatment

• Magnetic Stimulation and Neurological Trauma Therapy

• Magnetic Stimulation and Auditory Hallucinations

• Magnetic Stimulation and the Effects on Cerebral Blood Flow

• TMS Potential

• TMS/rTMS Instrument Parameters

• Neuroprosthetics

• Functional Electrical Stimulation (FES)

• Bidirectional Neuroprotheses

• Cochlear Implants

• Retinal Implants

• Neurostimulation for Depression

• The Neuron–Silicon Interface

• Physiology of EMS Applications

• Endurance Training by Increased Oxygen Supply

• Muscle Recovery via Increased Blood Flow

• Muscle Diagnostics with Electromyography

• Uncertainties in Electrostimulation Business Development Management

• Future advancements

• New technology challenges

CHAPTER SIX: MARKET SUMMARY

• Total Market Overview

• Geographical Market Analysis

CHAPTER SEVEN: COMPANY PROFILES
LIST OF EXHIBITS
CHAPTER ONE: EXECUTIVE SUMMARY

• Summary Table: Electrical and Neurostimulation Equipment/Device Market by Application Method, 2010-2017

• Summary Figure: Electrical and Neurostimulation Equipment/Device Market by Application Method, 2010-2017

CHAPTER TWO: INTRODUCTION TO ELECTROSTIMULATION AND RELATED TECHNOLOGIES

• Table 2-1: Energy/Radiation Stimulation Medical Electronics Products

• Table 2-2: Implanted Electrode Stimulation Technologies

• Table 2-3: Market Drivers Impacting Electrostimulation Equipment Sales

• Table 2-4: Market Restraints Limiting Electrostimulation Equipment Sales

• Table 2-5: Standard Industrial Codes (SIC) for Electrical/Magnetic Stimulation Equipment

• Table 2-6: North American Industry Classification System (NAICS) Codes for Electrical/Magnetic Stimulation Equipment

• Table 2-7: Major Players by Segment, 2012

• Table 2-8: US Healthcare Practitioners by Occupation Title, 2010

CHAPTER THREE: EXTERNAL ELECTRICAL STIMULATION DEVICES

• Table 3-1: Electrode Stimulation Modalities with External Electrodes Type and Description

• Table 3-2The World Market for External Bone Growth Stimulation Devices 2010-2017

• Figure 3-1: The World Market for External Bone Growth Stimulation Devices 2010-2017

• Table 3-3: TENS and EMS Stimulation Modes

• Table 3-4: The World Market for TENS and EMS Devices 2010-2017

• Figure 3-2: The World Market for TENS and EMS Devices 2010-2017

• Table 3-5: The World Market for Ultrasound-Accelerated Fracture Healing Systems 2010-2017

• Figure 3-3: The World Market for Ultrasound-Accelerated Fracture Healing Systems 2010-2017

• Table 3-6: The World Market for Other External Electrostimulation Devices 2010-2017

• Figure 3-4: The World Market for Other External Electrostimulation Devices 2010-2017

• Table 3-7: External Electrostimulation Device Market by Product Type 2010-2017

• Figure 3-5: External Electrostimulation Device Market by Product Type 2010-2017

• Figure 3-6: External Electrostimulation Device Market by Product Type 2012 and 2017

CHAPTER FOUR: IMPLANTED ELECTRICAL AND NEUROLOGICAL STIMULATION DEVICES

• Table 4-1: The World Market for Implantable Bone Growth Stimulation Devices 2010-2017

• Figure 4-1: The World Market for Implantable Bone Growth Stimulation Devices 2010-2017

• Table 4-2: The World Market for Implantable Cardiac Rhythm Management Devices 2010-2017

• Figure 4-1: The World Market for Implantable Cardiac Rhythm Management Devices 2010-2017

• Table 4-3: The World Market for Spinal Cord Stimulation Devices 2010-2017

• Figure 4-2: The World Market for Spinal Cord Stimulation Devices 2010-2017

• Table 4-4: The World Market for Sacral Nerve Stimulation Devices 2010-2017

• Figure 4-3: The World Market for Sacral Nerve Stimulation Devices 2010-2017

• Table 4-5: The World Market for Vagus Nerve Stimulation Devices 2010-2017

• Figure 4-4: The World Market for Vagus Nerve Stimulation Devices 2010-2017

• Table 4-6: The World Market for Deep Brain Stimulation Devices 2010-2017

• Figure 4-5: The World Market for Deep Brain Stimulation Devices 2010-2017

• Table 4-7: The World Market for Gastric Electrical Stimulation Devices 2010-2017

• Figure 4-6: The World Market for Gastric Electrical Stimulation Devices 2010-2017

• Table 4-8: Implantable Electrical and Neurological Stimulation Market by Product Segment 2010-2017

• Figure 4-7: Implantable Electrical and Neurological Stimulation Market by Product Segment 2010-2017

• Figure 4-8: Implantable Electrical and Neurological Stimulation Market by Product Segment 2012 and 2017

CHAPTER SIX: MARKET SUMMARY

• Table 6-1: Electrical and Neurostimulation Equipment/Device Market by Application Method, 2010-2017

• Figure 6-1: Electrical and Neurostimulation Equipment/Device Market by Application Method, 2010-2017

• Figure 6-2: Electrical and Neurostimulation Equipment/Device Market by Application Method, 2012 and 2017

• Table 6-2: Electrical and Neurostimulation Equipment/Device Market Estimated Sales by Geographic Region 2010-2017

• Figure 6-4: Electrical and Neurostimulation Equipment/Device Market Estimated Sales by Geographic Region 2010-2017

• Figure 6-5: Electrical and Neurostimulation Equipment/Device Market Estimated Sales by Geographic Region 2012 and 2017

To order this report: Cardiovascular Devices Industry: Markets for Electrostimulation Devices (Neurostimulation, Cardiac Rhythm Management, Fracture Healing and Others)
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SOURCE Reportlinker

http://www.sacbee.com/2012/08/06/4696746/markets-for-electrostimulation.html

Laryngoscope. 2012 Aug 1. doi: 10.1002/lary.23411. [Epub ahead of print]

Safety analysis of vagal nerve stimulation for continuous nerve monitoring during thyroid surgery.

Friedrich C, Ulmer C, Rieber F, Kern E, Kohler A, Schymik K, Thon KP, Lamadé W.

Source

Department of General and Visceral Surgery, Robert Bosch Hospital, Stuttgart; Dr. Margarete Fischer Bosch Institut for Clinical Pharmacology at the Robert Bosch Hospital, Stuttgart, Germany. cmfriedrich@gmx.de.

Abstract

OBJECTIVES/HYPOTHESIS:

Intraoperative neuromonitoring (IONM) facilitates recurrent laryngeal nerve (RLN) identification, but various studies affirm virtually unchanged postoperative RLN palsy rates. Several authors meanwhile suggest continuous intraoperative neuromonitoring (CIONM) via vagal nerve stimulation (VNS) to improve RLN protection. However, knowledge of side effects of electrical VNS derives mainly from its therapeutic applications in the fields of neurology and psychiatry. The presented study was conducted to further evaluate the safety of CIONM and identify possible VNS related side effects.

STUDY DESIGN:

Prospective nonrandomized controlled trail.

METHODS:

Forty patients scheduled for thyroid or parathyroid surgery were enrolled in the trail. The intervention group consisted of 22 patients receiving VNS for CIONM. Eighteen patients were operated on with routine IONM. To assess VNS-induced effects on the autonomic nervous system (ANS), heart rate variability analysis (HRVA) was applied. Serum cytokine levels of tumor necrosis factor (TNF)-α were monitored to evaluate immunomodulatory effects of VNS.

RESULTS:

HRVA revealed significantly increased vagal activity during CIONM. This parasympathetic predominance was not countered by the sympathetic nervous system. Despite a significant increase of vagal tone, no hemodynamic events occurred; in fact, no significant changes in median heart rate or in median arterial blood pressure were detected. Even though anti-inflammatory effects of VNS have been reported, no attenuation of cytokine release of TNF-α was measured.

CONCLUSIONS:

VNS for CIONM resulted in increased vagal activity assessable via HRVA. The increased parasympathetic tone affected neither hemodynamics nor levels of the proinflammatory cytokine TNF-α. VNS for CIONM appears safe with the applied settings. Laryngoscope, 2012.
Copyright © 2012 The American Laryngological, Rhinological, and Otological Society, Inc.

PMID:

22865548

[PubMed - as supplied by publisher]

http://www.ncbi.nlm.nih.gov/pubmed/22865548

Neuromodulation. 2012 Jul 31. doi: 10.1111/j.1525-1403.2012.00487.x. [Epub ahead of print]

Willingness to Accept and Pay for Implantable Tinnitus Treatments: A Survey.

Engineer ND, Rosellini WM, Tyler RS.

Source

MicroTransponder, Inc., 2802 Flintrock Trace, Suite 225, Austin, TX, USA; Department of Otolaryngology-Head and Neck Surgery, University of Iowa, Iowa City, IA, USA.

Abstract

Objectives:  At present, there is no cure for tinnitus. Neurostimulation techniques have shown great promise, but it is uncertain whether they will gain acceptance because of their invasive nature. We have previously demonstrated that pairing acoustic stimuli with vagus nerve stimulation (VNS) also has potential as a viable tinnitus treatment approach. Methods:  We conducted a survey on tinnitus sufferers that emphasized questions related to a willingness to pay for the treatment of tinnitus, including VNS. Four hundred thirty-nine individuals responded to an Internet survey modeled after a recent study by Tyler. Results:  The average age was about 47 years. Ninety-four percent reported that they had health insurance. Almost 40% had spent between $500 and $10,000 on tinnitus therapies. Almost three-fourths said that they would be willing to have a device implanted if it reduced tinnitus annoyance by half. About 70% of those with very loud tinnitus would be willing to have a temporary implant, and about 60% would be willing to have a permanent implant even if the device suppressed their tinnitus by only half of its annoyance. Only 10% of patients with SOFT tinnitus would be willing to have a permanent implant if the therapy suppressed their tinnitus by only half of its annoyance. Conclusions:  We conclude that implanted devices, such as a VNS, will be an acceptable form of tinnitus treatment for many who suffer from tinnitus. The results of this survey indicate that VNS tone pairing would be an acceptable therapeutic solution for individuals with moderate to severe tinnitus and should be developed for the market.
© 2012 International Neuromodulation Society.

PMID:

22849609

[PubMed - as supplied by publisher]

http://www.ncbi.nlm.nih.gov/pubmed/22849609