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

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

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.

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• 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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  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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• 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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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

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• 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.

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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].

  Dietrich S, Smith J, Scherzinger C, Hofmann-Preiss K, Freitag T, Eisenkolb A, Ringler R. Biomed Tech (Berl). 2008 Jun; 53(3):104-11.
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• 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

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  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]
  Review Novel anesthetics and other treatment strategies for refractory status epilepticus.

  Rossetti AO. Epilepsia. 2009 Dec; 50 Suppl 12:51-3.

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