Cyberonics reneged on its "Lifetime Reimbursement Guarantee". Click on the image to learn how you can help...

Saturday, July 28, 2012

Vagal nerve stimulation for refractory epilepsy: the surgical procedure and complications in 100 implantations by a single medical center.

2012 Jul 27. [Epub ahead of print]

Vagal nerve stimulation for refractory epilepsy: the surgical procedure and complications in 100 implantations by a single medical center.

Horowitz G, Amit M, Fried I, Neufeld MY, Sharf L, Kramer U, Fliss DM.

Source

Department of Otolaryngology, Head and Neck and Maxillo-facial Surgery, Tel-Aviv Sourasky Medical Center, Sackler Faculty of Medicine, Tel-Aviv University, 6 Weizmann St, 64239, Tel-Aviv, Israel.

Abstract

In 1997, the US Food and Drug Administration approved the use of intermittent stimulation of the left vagal nerve as adjunctive therapy for seizure control. Vagal nerve stimulation (VNS) has since been considered a safe and effective treatment for medically intractable seizures. The objective of this study is to present our experience with the surgical procedure and outcomes after VNS insertion in the first 100 consecutive patients treated at the Tel-Aviv "Sourasky" Medical Center (TASMC). All patients who underwent VNS device implantation by the authors at TASMC between 2005 and 2011 were studied. The collected data included age at onset of epilepsy, seizure type, duration of epilepsy, age at VNS device implantation, seizure reduction, surgical complications, and adverse effects of VNS over time. Fifty-three males and 47 females, age 21.2 ± 11.1 years, underwent VNS implantation. Indications for surgery were medically refractory epilepsy. The most common seizure type was focal (55 patients, 55 %). Seizure duration until implantation was 14.4 ± 9 years. Mean follow-up time after device insertion was 24.5 ± 22 months. Complications were encountered in 12 patients. The most common complication was local infection (6 patients, 6 %). Six devices were removed-four due to infection and two due to loss of clinical effect. Currently, 63 patients remain in active long-term follow-up; of these, 35 patients have >50 % reduction in frequency of attacks.VNS is a well-tolerated and effective therapeutic alternative in the management of medically refractory epilepsy. The surgical procedure is safe and has a low complication rate.
PMID:
22836871
[PubMed - as supplied by publisher]

http://www.ncbi.nlm.nih.gov/pubmed/22836871
 

 

FW: The Effects Of Epilepsy On The Body 

maggie.danhakl maggie.danhakl@healthline.com

6:37 AM (Wednesday, October 8, 2014)

 

Posted by at No comments:
Labels: , , ,

Thursday, July 26, 2012

Efficacy of Transcranial Magnetic Stimulation for Depression Confirmed in New Study

Efficacy of Transcranial Magnetic Stimulation for Depression Confirmed in New Study


In one of the first studies to look at transcranial magnetic stimulation (TMS) in real-world clinical practice settings, researchers at Butler Hospital, along with colleagues across the US, confirmed that TMS is an effective treatment for patients with depression who are unable to find symptom relief through antidepressant medications. (Credit: Butler Hospital)
ScienceDaily (July 26, 2012) — In one of the first studies to look at transcranial magnetic stimulation (TMS) in real-world clinical practice settings, researchers at Butler Hospital, along with colleagues across the U.S., confirmed that TMS is an effective treatment for patients with depression who are unable to find symptom relief through antidepressant medications. The study findings are published online in the June 11, 2012 edition of Depression and Anxiety in the Wiley Online Library.
Previous analysis of the efficacy of TMS has been provided through more than 30 published trials, yielding generally consistent results supporting the use of TMS to treat depression when medications aren't sufficient. "Those previous studies were key in laying the groundwork for the FDA to approve the first device for delivery of TMS as a treatment for depression in 2008," said Linda Carpenter, MD, lead author of the report and chief of the Mood Disorders Program and the Neuromodulation Clinic at Butler Hospital. "Naturalistic studies like ours, which provide scrutiny of real-life patient outcomes when TMS therapy is given in actual clinical practice settings, are the next step in further understanding the effectiveness of TMS. They are also important for informing healthcare policy, particularly in an era when difficult decisions must be made about allocation of scarce resources."

Carpenter explains that naturalistic studies differ from controlled clinical trials because they permit the inclusion of subjects with a wider range of symptomatology and comorbidity, whereas controlled clinical trials typically have more rigid criteria for inclusion. "As a multisite study collecting naturalistic outcomes from patients in clinics in various regions in the U.S., we were also able to capture effects that might arise from introducing a novel psychiatric treatment modality like TMS in non-research settings," said Carpenter. In all, the study confirms how well TMS works in diverse settings where TMS is administered to a real-life population of patients with depression that have not found relief through many other available treatments.

The published report summarized data collected from 42 clinical TMS practice sites in the US, and included outcomes from 307 patients with Major Depressive Disorder (MDD) who had persistent symptoms despite the use of antidepressant medication. Change during TMS was assessed using both clinicians' ratings of overall depression severity and scores on patient self-report depression scales, which require the patient to rate the severity of each symptom on the same standardized scale at the end of each 2-week period. Rates for "response" and "remission" to TMS were calculated based on the same cut-off scores and conventions used for other clinical trials of antidepressant treatments. Fifty-eight percent positive response rate to TMS and 37 percent remission rate were observed.

"The patient outcomes we found in this study demonstrated a response rate similar to controlled clinical trial populations," said Dr. Carpenter, explaining that this new data validates TMS efficacy in treating depression for those who have failed to benefit from antidepressant medications. "Continued research and confirmation of the effectiveness of TMS is important for understanding its place in everyday psychiatric care and to support advocacy for insurance coverage of the treatment." Thanks in part to the advocacy efforts of Dr. Carpenter, TMS was recently approved for coverage by Medicare in New England, and it is also now covered by BCBSRI. "Next steps for TMS research involve enhancing our understanding of how to maintain positive response to TMS over time after the course of therapy ends and learning how to customize the treatment for patients using newer technologies, so TMS can help even more patients."

http://www.sciencedaily.com/releases/2012/07/120726180305.htm
Posted by at 1 comment:
Labels: , ,

Is Vagus Nerve Stimulation Therapy a Good Treatment for Epilepsy

Is Vagus Nerve Stimulation Therapy a Good Treatment for Epilepsy

Posted by at No comments:
Labels: , ,

Friday, July 20, 2012

110 Modulation of the inflammatory response: a potential novel use for vagus nerve stimulation.

2012 Aug;71(2):E546.

110 Modulation of the inflammatory response: a potential novel use for vagus nerve stimulation.

Vadivelu S, McCarty M, Chavan S, Stream S, Tracey KJ, Mehta A.

Abstract

INTRODUCTION:

: The neural modulation of the immune response is thought to be mediated, in part, through the vagus nerve. Prior studies in experimental animals have shown vagus nerve stimulation to modulate cytokines response to inducers of inflammation. Tumor necrosis factor (TNF) is a cytokine that is known to play an important role in the pathophysiology of sepsis and other inflammatory disorders. The production of TNF in response to endotoxin challenge can be used as an index of the magnitude of the inflammatory response. We studied 7 patients who underwent vagus nerve stimulation for epilepsy to investigate for changes in TNF induction and this response over time.

METHODS:

: We conducted a prospective clinical study recruiting patients with intractable epilepsy who underwent vagus nerve stimulator implantation. Peripheral whole blood was drawn on the day of surgery at four time points peri-operatively (timed before and after intraoperative stimulation): 1. prior to anesthesia, 2. after anesthetic induction and anterior cervical dissection, 3. after vagal nerve stimulation in situ, and 4. four hours after vagal nerve stimulation. On each follow-up clinical visit a before and after vagus nerve stimulation blood draw was obtained. Whole blood samples were stimulated with endotoxin lipopolysaccharide concentrations 0.1, 1, and 10 ng/mL ex vivo. TNF responses were recorded.

RESULTS:

: Seven epileptic patients consented to the study (male = 4, female = 3). Four patients (4/7 [57%]) demonstrated TNF response suppression after direct vagus nerve stimulation intraoperatively. We found 4/5 [80%] patients (2 patients without follow-up) with serial follow-up visits to sustain chronic suppression of inflammatory responses. No patients experienced intraoperative complications or developed adverse events from serial phlebotomy.

CONCLUSION:

: Results here support the theory of a direct link between the brain and systemic inflammation via the vagus nerve in humans. This paves the way for the use of vagus nerve stimulation as treatment for inflammatory disorders.
PMID:
22811099
[PubMed - in process]
http://www.ncbi.nlm.nih.gov/pubmed/22811099

Related citations in PubMed


See reviews...See all...
Posted by at No comments:
Labels: , , ,

Wednesday, July 11, 2012

Teens hold 'tea party' as alternative to dance

Teens hold 'tea party' as alternative to dance

10:00 PM, Jun 23, 2012


Written by
KARL PUCKETT


Taylor Held, a junior at Great Falls High, holds a 'dance alternative' party in Gibson Park with her friends. TRIBUNE PHOTO/ABBY REDFERN
Taylor Held, a junior at Great Falls High, holds a 'dance alternative' party in Gibson Park with her friends. TRIBUNE PHOTO/ABBY REDFERN
Tayler Held, a 17-year-old Great Falls High School Student, used to space out dozens of times a day. She was having "absence seizures," the result of epilepsy.

"You kind of just sit there and you zone out and don't hear anything anybody says," Held said.
Today, the absence seizures are gone.

The only reminder of them is a tiny scar on her upper chest. That's where a battery, or pulse generator, about the size of a 50-cent piece was implanted. A thread-like wire attached to the battery runs through her neck and delivers a shock to the brain for 30 seconds every five minutes.

It's called Vagus Nerve Stimulation Therapy.

"It's kind of like a pacemaker, but it's for your brain," Held said.

Held and about 20 of her friends gathered Saturday at Gibson Park in Great Falls to have a "tea party" in which they drank sweet tea, talked and had a good time. The event — not a "dance" they said — was an alternative for students who say they dislike the "grinding" that occurs at school-sponsored dances.

But in Held's case, the dirty dancing wasn't just a turn-off. Strobe lights at a dance could trigger a seizure.

"I don't want to be a bearer of bad news and tell them to turn them off," she said. "We've been saying, 'We should throw our own party.'"

VNS Therapy is manufactured by Cyberonics Inc. in Houston Texas.

The pacemaker-like device delivers mild, intermittently pulsed signals to the patient's left vagus nerve, which then activates various areas of the brain.

More than 60,000 patients have used the VNS Therapy for treatment of refractory epilepsy, according to the company.

Held said she used to have 100 absence seizures a day, each lasting about 10 seconds. Her grades started to drop,

She had her first grand mal seizure when she was in the seventh grade. She was diagnosed with epilepsy when she was 12. Medication for the epilepsy caused depression, which affected her grades and her outlook.

Then a year ago, Held received the implant.

"Now I feel more outgoing and stuff because of it," she said.

Held has not had an absence seizure since. She's had three grand mal seizures.

James McGary, Held's 17-year-old boyfriend, says he's noticed a difference.

"I think it's really helped her out because she doesn't just have to keep taking medications," he said.
Today, he worries more about her than she does about herself, he said.

Held started painting when she was diagnosed with epilepsy and hopes to one day be a painter, an art teacher or both. Most of her work to date has been abstract or scenery paintings but she's also work on a few portraits of people.

She's considering attending Montana State University in Bozeman.

http://www.greatfallstribune.com/article/20120624/NEWS01/206240316?nclick_check=1
Posted by at No comments:
Labels: , ,

Vagus nerve stimulation for partial and generalized epilepsy from infancy to adolescence.

2012 Jul 6. [Epub ahead of print]

Vagus nerve stimulation for partial and generalized epilepsy from infancy to adolescence.

Thompson EM, Wozniak SE, Roberts CM, Kao A, Anderson VC, Selden NR.

Source

Departments of Neurological Surgery and.

Abstract

Object Vagus nerve stimulation (VNS) is approved by the FDA for the treatment of partial epilepsy in patients older than 12 years. Authors of the current study performed a large retrospective analysis and comparison of VNS outcomes in children with an age ≥ and < 12 years, including those with partial and generalized epilepsy. Methods A retrospective review of the records of pediatric patients (age < 18 years) who had undergone primary VNS system implantation between 2001 and 2010 by a single pediatric neurosurgeon was undertaken. Considered data included demographics, epilepsy type (partial vs generalized), seizure frequency, seizure duration, postictal period duration, and antiepileptic medication use. Results One hundred forty-six patients (49% female) were followed up for a mean of 41 months after VNS implantation. Thirty-two percent of patients had partial epilepsy and 68% had generalized epilepsy. After VNS system implantation, seizure frequency was reduced in 91% of patients, seizure duration in 50%, postictal period in 49%, and antiepileptic medication use in 75%. There was no significant difference in age, sex, or duration of follow-up according to epilepsy type. Neither was there any significant difference in seizure frequency reduction, seizure duration, postictal period, medication use, overall clinical improvement, or improvement in quality of life based on an age ≥ or < 12 years or epilepsy type. Conclusions Vagus nerve stimulation reduced both seizure frequency and antiepileptic medication use in the majority of pediatric patients regardless of sex, age cohort, or epilepsy type. Vagus nerve stimulation also reduced seizure duration and postictal period in approximately half of the pediatric patients. Contrary to expectation, children with partial epilepsy do not benefit from VNS at higher rates than those with generalized epilepsy.

http://www.ncbi.nlm.nih.gov/pubmed/22768964

Related citations in PubMed


See reviews...See all...
Posted by at No comments:
Labels: , ,

Short-term Results of Vagus Nerve Stimulation in Pediatric Patients with Refractory Epilepsy.

2012 Jun;53(3):184-7. Epub 2012 Jun 5.

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.

Source

Department of Pediatrics, Chung Shan Medical University and Hospital, Taiwan.

Abstract

BACKGROUND:

Vagus nerve stimulation (VNS), an alternative method to manage patients with medically intractable epilepsy, has shown favorable results in reducing seizure relapse and improvements in quality of life. In 1997, the U.S. Food and Drug Administration approved the use of this device as an adjunctive therapy for intractable seizure in adults and adolescents older than 12 years of age.

METHODS:

We present a preliminary study of pediatric patients, who suffered from medically intractable seizure and underwent VNS implantation after observation of the baseline seizure frequency. Classification of epileptic syndrome, seizure patterns, age of onset, seizure frequency reduction and adverse effects were recorded.

RESULTS:

Patients who underwent VNS implantation included four adolescents and four children. The follow-up duration ranged from 9-33 months. All the patients were responders after the beginning of the stimulation. Five of the eight patients responded to VNS with a seizure frequency reduction rate > 50%, and four of the eight patients experienced a ≥ 90% seizure reduction. No significant adverse effects were noted in all patients during the observation period.

CONCLUSION:

The effective management of medically intractable seizure remains challenging to most clinical physicians. In addition to ketogenic diet and epilepsy surgery, VNS provides an alternative way to manage this issue. Our results suggest that VNS is well tolerated in pediatric patients, and is a favorable and safe method of treating intractable seizure in common clinical practice.

http://www.ncbi.nlm.nih.gov/pubmed/22770107

Related citations in PubMed


See reviews...See all...

Recent activity

Clear Turn Off Turn On
Your browsing activity is empty.
Activity recording is turned off.
See more...
Posted by at No comments:
Labels: , ,

Patients need drug options, not limitations


THE HILL
comment
Print

Patients need drug options, not limitations

By Michael J. Fitzpatrick, executive director, National Alliance on Mental Illness - 07/09/12 02:50 PM ET
Imagine being sick with a life-threatening disease. Most of us would want access to as many medicines as possible -- including the full range of proven treatment options. 


But under the Affordable Care Act, some people may see their drug choices severely restricted.




A draft regulation proposed by the Department of Health and Human Services would require insurers participating in the law's new exchanges to cover only a single drug in each class of pharmaceuticals. 

That could be a disaster for both patients and doctors. Those living with chronic conditions -- think serious mental illness, HIV-AIDS, epilepsy, or kidney disease -- would be hit particularly hard. "One-size-fits-all" may work for baseball hats, but medication requires a far more individualized approach. Doctors know that each patient responds differently to treatment. Patients need all the options they can get. 


That's part of the reason Medicare's prescription drug benefit has been so important. Medicare Part D requires participating plans to cover at least two different drugs in most every class of pharmaceutical -- and nearly all drugs in six important classes: immunosuppressants, antidepressants, antipsychotics, anticonvulsants, antiretrovirals, and antineoplastics.


Medicare Part D's requirements were designed to ensure continuity and access for vulnerable patients. Its rules should be a model for the new regulation.


Similar drugs within the same category can have dramatically different results among patients. A drug that works for your neighbor might not work for you

.
Choice works in tandem with innovation to give patients the best chance of recovery. Requiring insurers to cover just a single drug in each class would likely cause many to skip covering new drugs, even if they represent clinical improvements in efficacy and/or safety.


This issue is especially important for the mental health community. Diagnoses in serious mental illness remain imprecise. It is not uncommon for a patient to receive multiple inaccurate diagnoses over several years before being correctly diagnosed and receiving effective treatment.


Persons with depression, bipolar disorder, or schizophrenia don't always respond to their first or second rounds of treatment -- and often require multiple attempts with multiple combinations of medications before something finally succeeds. There's no way of knowing in advance exactly what will work. This is why doctors and patients need all available options.


Research into drug access for Medicaid beneficiaries starkly illustrates the problem of restrictions on medicines. According to one recent study, psychiatric patients with medication access issues had three times the rate of suicidal thoughts and behavior. When these patients were forced to switch drugs because of a lack of coverage, they reported far higher rates of hospitalization, homelessness, and incarceration. 


When it comes to prescription drug coverage, what patients need most is access and choice. 

The Department of Health and Human Services understands this issue. Indeed, this same draft regulation about the healthcare law's exchanges contains strong language ensuring "mental health parity," which requires insurers to cover both mental and physical health equally. Prescription drug coverage should not fall short of this standard for equitable coverage. 


The Department of Health and Human Services is expected to make its final ruling on drug access in the insurance exchanges within the next two weeks. Between now and then, it's imperative that Department officials revise this regulation to protect patients. 


Fitzpatrick is executive director at NAMI, the National Alliance on Mental Illness.
Source:
http://thehill.com/blogs/congress-blog/healthcare/236763-patients-need-drug-options-not-limitations
Posted by at No comments:
Labels: , , ,
Subscribe to: Posts (Atom)