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

Wednesday, December 26, 2012

Cyberonics Announces 100,000th Patient Implant of VNS Therapy®

Cyberonics Announces 100,000th Patient Implant of VNS Therapy®

Announcement highlights important patient milestone during 25th anniversary year

HOUSTON, Dec. 20, 2012 /PRNewswire/ -- Cyberonics, Inc. (NASDAQ: CYBX) today announced the 100,000th patient implant of its Vagus Nerve Stimulation (VNS) Therapy system. The announcement comes as Cyberonics recognizes a milestone year marking the 25th anniversary of the company's founding. The VNS Therapy System for the treatment of epilepsy received CE Mark approval 18 years ago, and this year marks the 15th anniversary of approval by the United States Food and Drug Administration (FDA).
 
According to an Institute of Medicine Report released earlier this year, approximately one in 26 people will develop epilepsy at some point during their lives. VNS Therapy is a unique device-based treatment option specifically developed for people with refractory epilepsy. Epilepsy is considered refractory when seizures are not adequately controlled by medications alone or when the side effects associated with seizure medications are intolerable. Recently-published data from New York University clinician researchers show that more than 60 percent of people with refractory epilepsy treated with adjunctive VNS Therapy experience 50 percent or greater reduction in seizures. Clinician researchers from Emory University have also shown in a recent publication that adding VNS Therapy to the treatment regimen of patients experiencing refractory epilepsy is associated with significant reductions in resource utilization (ER visits, hospitalizations, and inpatient days) and epilepsy‐related clinical events, as well as a net cost savings after 1.5 years.
 
"Cyberonics is proud to acknowledge this important milestone and the impact VNS Therapy has made on the lives of so many people with epilepsy and their families," said Dan Moore , Cyberonics' President and Chief Executive Officer. "We look forward to expanding access to VNS Therapy and innovating new therapeutic options for patients around the world."
 
VNS Therapy device technology has evolved over time to become smaller, have a longer battery life and offer new programming functionalities. The latest model of VNS Therapy, the AspireHC® generator, is available in the U.S. and in Europe. The AspireHC generator offers physicians and patients additional options, such as longer battery life, improved electronics and enhanced programming features. Cyberonics continues to develop new device-based solutions for epilepsy, including the ProGuardian™ system, an innovative, in-home monitoring system; the AspireSR™ generator, a VNS Therapy system featuring automatic magnet-mode stimulation; and Relay™, a wireless-enabled generator.

http://www.prnewswire.com/news-releases/cyberonics-announces-100000th-patient-implant-of-vns-therapy-184314661.html

Friday, December 14, 2012

[Will electroconvulsive therapy disappear in the near future?].

2012;114(10):1208-15.

[Will electroconvulsive therapy disappear in the near future?].

[Article in Japanese]

Source

Department of Neuropsychiatry, Interdisciplinary Graduate School of Medicine and Engineering, University of Yamanashi.

Abstract

Electroconvulsive therapy (ECT) has been widely used, with some modification of its methods, for the treatment of refractory mental disorders. In Japan, brief-pulse ECT was approved in 2002 under conditions that well-trained psychiatrists should administer ECT and that modified ECT is mandatory. However, unmodified ECT is still often performed in Japan. We have to improve safety of ECT further. Major indications for ECT are depression and catatonia. Mechanisms of ECT are still unknown, but the neurogenesis hypothesis is promising. Furthermore, several brain stimulation techniques without seizure induction, such as transcranial magnetic stimulation, vagus nerve stimulation, deep brain stimulation and transcranial direct current stimulation, have been introduced for the treatment of refractory mental disorders. Ethical criteria must be determined for further research and treatment with these techniques.
PMID:
23234202
[PubMed - in process]

http://www.ncbi.nlm.nih.gov/pubmed/23234202

Sunday, November 11, 2012

Pilot Study Extension Indicates Long-Term Treatment Durability with BioControl Medical's CardioFit(R) System

press release
Nov. 8, 2012, 7:00 a.m. EST

Pilot Study Extension Indicates Long-Term Treatment Durability with BioControl Medical's CardioFit(R) System





YEHUD, Israel & NEW HOPE, Minn., Nov 08, 2012 (BUSINESS WIRE) -- BioControl Medical has announced that pilot study extension results unveiled at the American Heart Association Scientific Sessions 2012 have indicated durability of treatment with its CardioFit(R) system for heart failure. Presented on November 7 in "Long-term Benefits of Vagal Nerve Stimulation Therapy in Heart Failure," the extended study data showed that the CardioFit's favorable clinical effects - as demonstrated by improved hemodynamics, quality of life and six-minute walk test - were maintained in patients beyond the study's original six- and 12-month evaluation points, up to 24 months.(1)

"These results are an encouraging validation of vagus nerve stimulation's potential as an effective long-term treatment for heart failure," said Dr. Srdjan Raspopovic, Clinical Center of Serbia, Belgrade, Serbia, a CardioFit pilot study investigator who presented the data at AHA 2012. "Larger controlled studies are currently underway to confirm these findings, and if they do, we believe that VNS will become an important new treatment alternative in the heart failure armamentarium."

Conducted in Italy, Germany, The Netherlands and Serbia, the original multi-center pilot clinical study of the CardioFit was designed to assess the six-month safety and clinical response to the therapy in 32 patients with NYHA II-IV heart failure on optimized background medical therapy.

Study data showed that patients experienced sustained significant improvement across key clinical measures at six and 12 months, including left ventricular function and structure, heart rate variability, and resting heart rate.(2) Patients also showed improvement in self-reported quality of life surveys and six-minute hall walk tests.(2) The study extension's 24-month data, available on 19 patients, showed sustained clinical improvement with the CardioFit therapy. Patient follow up now extends beyond four years, with good therapy tolerance and no reported safety issues.

"The extended pilot results are important data that build on BioControl Medical's growing body of research supporting VNS for the treatment of heart failure," said Ehud Cohen, Ph.D., chief executive officer of BioControl Medical. "We thank the investigators for their rigorous work assessing the long-term effects of CardioFit in our early study, and we look forward to gathering more data on a broader population of patients as our pivotal clinical trial continues to advance."

The safety and efficacy of the CardioFit is being explored further in the INOVATE-HF (INcrease Of VAgal TonE in Heart Failure) global, multi-center, investigational device exemption (IDE) clinical study. Initiated in April 2011, INOVATE-HF is a prospective, randomized, controlled clinical study that will evaluate the system's potential to reduce hospitalization and death among patients with HF, while also exploring whether combined treatment with CardioFit and prescription drug therapy is more effective than drug therapy alone.(3)

INOVATE-HF will ultimately enroll up to 650 patients at up to 80 centers in the United States and Europe. Results of the INOVATE-HF study will be used to support a Premarket Approval Application (PMA) to the U.S. Food and Drug Administration (FDA) for market clearance of CardioFit.

About the CardioFit

The CardioFit system consists of a stimulator, a sensor lead and a stimulation lead, which are implanted under the skin of the chest. The sensor lead is extended from the stimulator to the right ventricle of the heart, and the stimulation lead is extended from the stimulator to the vagus nerve on the right side of the neck. Once activated, the stimulator's electrical pulses are transferred via the stimulation lead to the vagus nerve. At the same time, the sensor lead monitors changes in heart activity and turns stimulation on or off accordingly. Like a pacemaker, the CardioFit System can be programmed on and off via external wireless communication with the device.

About BioControl Medical

Headquartered in Yehud, Israel with offices in New Hope, Minn., BioControl Medical develops and markets advanced implantable devices for the treatment of autonomic disorders, conditions whereby the autonomic nervous system ceases to function properly, resulting in a disruption to the control of involuntary body processes. The devices enable controlled electrical stimulation of various nerves to achieve therapeutic results. For more information on BioControl Medical, visit www.biocontrol-medical.com .

Caution: In the United States, the CardioFit is an investigational device. Limited by Federal (or United States) law to investigational use.

References
(1)Dennert R, et al. "Long-term Benefits of Vagal Nerve Stimulation Therapy in Heart Failure." American Heart Association Scientific Sessions 2012.
(2)De Ferrari GM, Crijns HJ, Borggrefe M, Milasinovic G, Smid J, Zabel M, Gavazzi A, Sanzo A, Dennert R, Kuschyk J, Raspopovic S, Klein H, Swedberg K, Schwartz PJ. "Chronic vagus nerve stimulation: a new and promising therapeutic approach for chronic heart failure." Eur Heart J (2011) 32 (7): 847-855.
(3)Hauptman PJ, Schwartz PJ, Gold MR, Borggrefe M, Van Veldhuisen DJ, Starling, RC, Mann DL. "Rationale and study design of the INcrease Of Vagal TonE in Heart Failure study: INOVATE-HF." American Heart Journal (June 2012) 163 (6): 955-962.
SOURCE: BioControl Medical

http://www.marketwatch.com/story/pilot-study-extension-indicates-long-term-treatment-durability-with-biocontrol-medicals-cardiofitr-system-2012-11-08

Saturday, November 3, 2012

Auricular transcutaneous electrical nerve stimulation in depressed patients: a randomized controlled pilot study.

2012 Nov 2. [Epub ahead of print]

Auricular transcutaneous electrical nerve stimulation in depressed patients: a randomized controlled pilot study.

Source

Frankenalb-Klinik Engelthal, Clinic for Psychiatry, Psychotherapy, Psychosomatic Medicine, and Addiction Rehabilitation, Reschenbergstraße 20, 91238, Engelthal, Germany, ernst.hein@yahoo.de.

Abstract

Invasive vagus nerve stimulation has been demonstrated to be an effective treatment in major depressive episodes. Recently, a novel non-invasive method of stimulating the vagus nerve on the outer canal of the ear has been proposed. In healthy subjects, a prominent fMRI BOLD signal deactivation in the limbic system was found. The present pilot study investigates the effects of this novel technique of auricular transcutaneous electric nerve stimulation in depressed patients for the first time. A total of 37 patients suffering from major depression were included in two randomized sham controlled add-on studies. Patients were stimulated five times a week on a daily basis for the duration of 2 weeks. On days 0 and 14, the Hamilton Depression Rating Scale (HAMD) and the Beck Depression Inventory (BDI) were assessed. In contrast to sham-treated patients, electrically stimulated persons showed a significantly better outcome in the BDI. Mean decrease in the active treatment group was 12.6 (SD 6.0) points compared to 4.4 (SD 9.9) points in the sham group. HAMD score did not change significantly in the two groups. An antidepressant effect of a new transcutaneous auricular nerve stimulation technique has been shown for the first time in this controlled pilot study. Regarding the limitations of psychometric testing, the risk of unblinding for technical reasons, and the small sample size, further studies are necessary to confirm the present results and verify the practicability of tVNS in clinical fields.
PMID:
23117749
[PubMed - as supplied by publisher]

http://www.ncbi.nlm.nih.gov/pubmed/23117749

Related citations in PubMed


See reviews...See all...

Neurostimulation-past, present, and beyond.

2012 Sep;12(5):188-91. doi: 10.5698/1535-7511-12.5.188.

Neurostimulation-past, present, and beyond.

Source

Institution of Clinical Neuroscience and Physiology, Sahlgrenska Academy, Göteborgs University, 413 45 Göteborg, Sweden, ebm@neuor.gu.se.

Abstract

Neurostimulation as a treatment for epilepsy has been around for almost 20 years in the form of vagus nerve stimulation. Newer types of neurostimulation are being developed and stand on the brink of approval for use. The two newest therapies, not yet approved in the United States, are deep brain stimulation and the Responsive Neurostimulator System . In fact, in Europe, approval has already been given for deep brain stimulation and newer forms of vagus nerve stimulation. Efficacy is similar between these therapies, and side effects are moderate, so what will be the future? The challenge will be to learn how to use these therapies correctly and offer the right treatment for the right patient.
PMID:
23118604
[PubMed - in process]

http://www.ncbi.nlm.nih.gov/pubmed/23118604

Related citations in PubMed


See reviews...See all...

Friday, November 2, 2012

Long-term effectiveness and tolerability of vagal nerve stimulation in adults with intractable epilepsy: a retrospective analysis of 100 patients.

2012 Nov 1. [Epub ahead of print]

Long-term effectiveness and tolerability of vagal nerve stimulation in adults with intractable epilepsy: a retrospective analysis of 100 patients.

Source

Department of Neurosurgery, Institute of Neurosciences, Frenchay Hospital , Bristol , UK.

Abstract

Data for 100 vagal nerve stimulation (VNS) patients were collected and analysed retrospectively. The mean seizure reduction was 17.86% (n = 67) at 6 months, 26.21% (n = 63) at 1 year, 30.43% (n = 53) at 2 years, 48.10% (n = 40) at 3 years, 49.44% (n = 32) at 4 years, 50.52% (n = 35) at 5 years, 45.85% (n = 31) at 6 years, 62.68% (n = 25) at 8 years, 76.41% (n = 9) at 10 years, 82.90% (n = 4) at 12 years. Evidence of statistical significance for mean seizure reduction over time was strong with all p values less than 0.05 except at 12 years (p = 0.125) where the sample size was small (n = 4). Mean seizure reduction was 49.04% and 51 (51%) patients were considered responders, defined as a 50% or more reduction in seizure frequency. Twenty-one (21%) patients suffered surgical complications. Of these 15 patients were self-limiting and 6 patients were irreversible or required a device revision. Fifty patients (50%) suffered from side-effects, while vagal stimulation cycled on (VNS on) post-operatively. However, of these, only one patient suffered from intolerable side effects requiring the device to be switched off temporarily. This study demonstrates the long-term efficacy in seizure reduction with the use of VNS. Complication rates and tolerability did not deviate greatly from that previously reported, indicating that VNS is a safe and effective treatment for seizure reduction in intractable epilepsy.
PMID:
23113878
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/23113878

 

Thursday, November 1, 2012

Common Antidepressants Too Risky During Pregnancy, Researchers Say

Common Antidepressants Too Risky During Pregnancy, Researchers Say

But another expert disagrees, saying all options must be open to women faced with this situation

October 31, 2012 RSS Feed Print
By Amanda Gardner
HealthDay Reporter

WEDNESDAY, Oct. 31 (HealthDay News) -- Women who take a popular class of antidepressants during pregnancy may be risking the health of their developing fetus, and the risk may outweigh any benefit to the mother, a new review of data suggests.

According to new research, use of selective serotonin reuptake inhibitors (SSRIs) -- which include Celexa, Paxil, Prozac and Zoloft -- while pregnant can increase the risk of miscarriage, preterm birth, pregnancy complications such as preeclampsia and neurobehavioral problems such as autism later in life.

"There is clear and concerning evidence of risk when pregnant women use these medications," said Dr. Adam Urato, senior author of a study appearing in the Oct. 31 online edition of Human Reproduction.

On the other hand, he said, there is no clear evidence that SSRI antidepressants actually benefit the mother in terms of alleviating mild-to-moderate depression.

Not everyone agreed with the researchers' conclusions, however. Dr. Beatriz Currier is associate professor of psychiatry and behavioral sciences at the University of Miami Miller School of Medicine.

She said there is no blanket recommendation as to how best to treat depression during pregnancy and "every woman who presents to a clinician has to undergo a case-by-case analysis of the benefits and risks of antidepressant therapy."

Currier also said that there is "no conclusive data about an increased risk of miscarriage being associated with antidepressants." Nor is there any reason to conclude the rate of preeclampsia or birth defects is higher, she said, although there is some evidence that antidepressant use may be associated with low birth weight babies.

According to background information in the study, antidepressants are the most widely prescribed medications among adults aged 18 to 44. Up to 13 percent of pregnant women take an antidepressant. Many of these may be women undergoing treatment for infertility, a condition which is often accompanied by depression.

In 2010, up to almost 7,000 babies conceived by in vitro fertilization (IVF) may have been exposed to an antidepressant, the study authors said.

In their research, Urato and his team looked at the existing literature on women who had fertility problems and were also taking SSRIs. They say they found a number of concerns.

First of all, some studies suggest that SSRIs may actually undermine women's efforts to get pregnant, the researchers said. And for those who do get pregnant, the drugs may increase the risk for miscarriage as well as congenital problems in their children. The most striking association was for use of Paxil (paroxetine) during pregnancy and the risk for congenital heart defects, they said.
The study authors noted that, in 2005, the U.S. Food and Drug Administration requested that Paxil's maker, GlaxoSmithKline, change Paxil's pregnancy category from a "C" to a "D" rating, indicating that it poses a risk to the fetus.

The authors also pointed to a 2011 study from Kaiser Permanente Medical Care Program of Northern California that found a "twofold increased risk of autism spectrum disorders associated with maternal treatment with SSRI antidepressants during the pregnancy, with the strongest effect associated with treatment during the first trimester."

On the other hand, isn't untreated depression in a mother-to-be a hazard for both mother and fetus? According to Currier, sometimes SSRIs remain the best option for women facing this situation.
"Generally speaking, for women with very mild depression, the first course of treatment is that of cognitive behavioral therapy or other non-pharmacological [forms] of treatment," she said. "But in many cases, patients with moderate and severe depression will, in fact, require antidepressant therapy in order to treat their comorbid psychiatric illness, which cannot be ignored or dismissed," Currier added.

However, Urato said that an increasing number of studies are finding that SSRIs have little clinical benefit for mild-to-moderate depression when compared with a placebo (inactive) pill.
Other alternatives may exist for women who are battling depression, added study lead author Alice Domar, executive director of the Domar Center for Mind/Body Health at Boston IVF. The center is described on its Web page as focused on "enhancing the mind/body connection" through interventions such as "acupuncture, psychology, nutrition and restorative yoga."

According to Domar, cognitive behavioral therapy, in which patients learn how to direct their thinking and behavior to more constructive ends, probably has the most evidence behind it.
Exercise also has demonstrated efficacy, and yoga may have some benefit, she added.

"What I don't want to do is scare the heck out of women who are pregnant and have severe depression," Domar said. "I'm not suggesting that someone who is suicidal stop taking antidepressants cold turkey. You have to look at the individual risk-benefit ratio. In that case [suicidality], the risk of harm to her and her baby is far higher than the risk posed by an SSRI. For those with mild or moderate depression, the ratio shifts the other direction," she noted.

And, Urato added, "We're not saying women should not take SSRIs. The goal is to give them information so they can make the right decision for them."

More information
There's more about dealing with depression during a pregnancy at WomensHealth.gov.

http://health.usnews.com/health-news/news/articles/2012/10/31/common-antidepressants-too-risky-during-pregnancy-researchers-say

Wednesday, October 31, 2012

Medicare agrees to cover TMS treatment for depression in TN, GA, AL

Medicare agrees to cover TMS treatment for depression in TN, GA, AL

Tuesday, October 30, 2012

Electric brain stimulation gains ground


Electric brain stimulation gains ground

NEUROLOGY Electric stimulation under study to treat brain trauma from stroke to Parkinson's and even dementia

Victoria Colliver

Published 5:15 p.m., Tuesday, October 30, 2012
 
Dr. Emily Kappenman (left) prepares psychologist Michael Callaghan for transcranial direct current stimulation. Photo: Sarah Rice, Special To The Chronicle / SF
Dr. Emily Kappenman (left) prepares psychologist Michael Callaghan for transcranial direct current stimulation. Photo: Sarah Rice, Special To The Chronicle / SF


Dr. Marom Bikson, who developed the transcranial direct current stimulation device, demonstrates the product at the Highland Hospital workshop. Photo: Sarah Rice, Special To The Chronicle / SF
Dr. Marom Bikson, who developed the transcranial direct current stimulation device, demonstrates the product at the Highland Hospital workshop. Photo: Sarah Rice, Special To The Chronicle / SF

 
Internist Kim Wood from Joplin, Mo., watches Marom Bikson demonstrate how to use the device. Photo: Sarah Rice, Special To The Chronicle / SF
Internist Kim Wood from Joplin, Mo., watches Marom Bikson demonstrate how to use the device. Photo: Sarah Rice, Special To The Chronicle / SF

Applying a current of electricity through the brain conjures up the kind of nightmare-inducing seizures immortalized in the 1975 film adaption of Ken Kesey's "One Flew Over the Cuckoo's Nest."
But a kinder, gentler, almost imperceptible form of electric brain stimulation - an experimental approach known as transcranial direct current stimulation - is gaining traction as a promising therapy for brain injuries due to stroke or other traumas, depression, dementia, attention-deficit disorder and other conditions.
Transcranial direct current stimulation, or tDCS, bears little in common with electroshock therapy or invasive forms of deep brain stimulation, which involve drilling holes in the head and implanting electrodes.
The level of the current used is tiny - typically between 1 and 2 milliamps, or less than one-one-hundredth of a single electrical watt. At most, the current causes a tingling or slight itching, if it's felt at all.
Even the technique's staunchest defenders acknowledge that the idea of treating a broad range of disorders with something you can hardly feel and that has few, if any, side effects sounds more like snake oil than science.
"How could this do anything? It seems so small. We're talking about a few volts," said Marom Bikson, associate professor of biomedical engineering at City University of New York who co-founded Soterix Medical Inc., a company that holds patents to Bikson's transcranial direct current stimulation devices.
Jolt to the brain
But Bikson said studies have shown a few volts of current can change the rate at which a brain cell fires in a way that is believed to improve brain plasticity, or its ability to change and learn new things.
"It's not some magical, unknown hocus-pocus," he said.
The concept is fairly simple: After dampened electrodes are strapped to a patient's scalp, a device charged by a 9-volt battery - the kind used in transistor radios - delivers a small current to change the activity in targeted regions of the brain.
The current, which is typically delivered for 10 to 30 minutes over multiple sessions, is thought to be able to excite or inhibit the brain's neurons in the stimulated area.
A positive current could help people with depression, stroke or other brain traumas, while a negative current may be helpful for such conditions as epilepsy or language recovery. Both currents can be used at the same time, and the effects of the stimulation are thought to continue or even increase, even after the device has been turned off.
Transcranial direct current stimulation has been used in a small number of hospitals - mostly on the East Coast - since about 2000 but has not been approved by the U.S. Food and Drug Administration. Soterix and other manufacturers plan to seek FDA approval for the devices once enough research has been done.
Earlier this month, Bikson was part of a research team that demonstrated the technique for doctors, therapists and other health experts during a one-day workshop at Alameda County Medical Center's Highland Hospital in Oakland.
Getting the word out
Dr. Lance Stone, medical director of rehabilitation and restoration at the county's Fairmont Hospital in San Leandro, was introduced to the technique earlier this year and invited the researchers to give his colleagues and other specialists the opportunity to learn more about it.
Stone is interested in the device's use in the emerging field of neurorehabilitation, which teaches or retrains patients with nervous system injuries such as stroke, Parkinson's disease or other brain trauma.
"There seems to be countless potential applications (of the technique) for acquired neurological disorders, but the main ones seem to be primarily pain, motor recovery and depression," said Stone, who plans to apply for a research grant to study the device.
The concept of using electrical stimulation for health purposes dates back thousands of years to the Greeks, whose medical practitioners were said to use electric eels in water to reduce symptoms of arthritis and other types of pain.
Modern usage of electroconvulsive therapy, formerly known as electroshock therapy, has been controversial, dating back to its early use in the 1940s and '50s in psychiatric hospitals. While it has been making a bit of a lower-voltage comeback in patients with severe depression, the method is generally considered a last resort because of the risk of memory loss and other side effects.
Trials and studies
Transcranial direct current stimulation has been around for decades, but the technique earned interest in the 1990s and early 2000s after some European physicians published promising results of the work. Currently it's the subject of numerous ongoing clinical trials and studies in this country.
In 2010, a team of Oxford University scientists published a small study that showed tDCS improved math skills in the majority of participants.
That same year, researchers at Beth Israel Deaconess Medical Center in Boston published findings that showed that the motor skills of stroke patients treated with the device, along with physical and occupational therapy, improved threefold compared with those who received a placebo form of stimulation and the same amount of physical and occupational therapy.
But some health experts warned that the technique's safety and effectiveness are unknown and that larger, controlled human clinical trials are needed.
"Whenever you do something - whether it's swallowing a drug or applying current - there may be a downside," said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, a consumer and health advocacy lobbying organization.
Sounds promising
Wolfe said the device sounds promising and is the subject of a myriad of clinical trials but shouldn't be approved until the larger, controlled studies are conducted. "The variety of medical problems for which they are trying this is enormous, and in most of the studies the number of patients is so small it's not statistically significant," he said.
Dr. Dylan Edwards, director of the Non-Invasive Brain Stimulation and Human Motor Control Laboratory at Burke Medical Research Institute in White Plains, N.Y., agreed that further research is needed to answer many of the unknown questions. His institute received a $3.5 million grant from the National Institutes of Health to study the device's effectiveness in stroke patients.
"The brain is an electrical organ," said Edwards. "What we're trying to do is develop methods that interfere with brain activity in a targeted way and positively influence it."
Edwards said several companies in the United States and around the world are already making transcranial direct current stimulation devices and he expects more.
Part of the appeal of the device is that it is relatively low cost - retailing for about $800. In addition, it's portable, so it can be used in many different settings.
Using on patients
Some doctors and researchers who attended the recent workshop had no experience using the device, while others had already tried it on a few patients. The device, which is considered investigational by the U.S. Food and Drug Administration, can be used either as part of a clinical trial or by a medical doctor for specific cases.
UC Berkeley psychologist Ludovica Labruna has experimented with using the device for language acquisition - to see if subjects could learn languages more quickly after receiving tDCS sessions. But she said her results have been somewhat disappointing, and she's not sure if she's using the device correctly.
"TDCS looks so simple, but it's really not so simple to apply because there are so many variables," Labruna said. "You really need to be trained."
Similar concerns drew Emily Kappenman to the workshop.
Kappenman, a postdoctoral researcher at UC Davis' Center for the Mind and Brain, said she's interested in the device's potential for working with patients with anxiety. She said she's tried it to see whether it helps people become less distracted and anxious by moving their attention away from certain emotions.
"It's hard to tell if it's working yet or if we're using optimal levels," she said. "It's hard to know what's best."
Brain stimulation
Brain stimulation uses magnetic or electrical energy to improve brain function. Here are some of the techniques in use or being studied:
Electroconvulsive therapy (ECT): With ECT, an electric current passes briefly through the scalp to the brain, inducing a seizure. It's generally considered only for those with severe depression or other serious mental illnesses who do not respond to other treatments.
Transcranial magnetic stimulation (TMS): TMS uses wrapped coil wires to generate electric current throughout the scalp and can induce involuntary movements. Although it has a few potentially serious side effects, including seizures, the treatment received federal approval for patients with severe depression in 2008.
Transcranial direct current stimulation (tDCS): Weaker still than TMS, tDCS has not been approved, but researchers are studying its use to help patients with strokes and other brain injuries. It has also been considered for use in healthy subjects, with researchers testing everything from memory enhancement to improved golf swing.
Source: Chronicle research
Victoria Colliver is a San Francisco Chronicle staff writer. E-mail: vcolliver@sfchronicle.com
 

Wednesday, October 24, 2012

Scalp-recorded evoked potentials as a marker for afferent nerve impulse in clinical vagus nerve stimulation.

2012 Oct 11. pii: S1935-861X(12)00161-1. doi: 10.1016/j.brs.2012.09.007. [Epub ahead of print]

Scalp-recorded evoked potentials as a marker for afferent nerve impulse in clinical vagus nerve stimulation.

Source

Department of Neurosurgery, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan.

Abstract

BACKGROUND:

Vagus nerve stimulation (VNS) is a palliative treatment for drug resistant epilepsy for which the efficacy and safety are well established. Accumulating evidence suggests that ascending vagal signals modulate abnormal cortical excitability via various pathways. However, there is no direct evidence for an ascending conduction of neural impulses in a clinical case of VNS.

OBJECTIVE:

We recorded and analyzed the short-latency components of the vagus nerve (VN) evoked potential (EP) from the viewpoint of determining whether or not it is a marker for the ascending neural conduction.

METHODS:

EPs within 20 ms were prospectively recorded simultaneously from a surgical wound in the neck and at multiple scalp sites during implantation surgery in 25 patients with drug-resistant epilepsy. Electrical stimulation was delivered using the clinical VNS Therapy system. A recording was made before and after a muscle relaxant was administered, when changing the rostrocaudal position of stimulation, or when stimulating the ansa cervicalis instead of the VN.

RESULTS:

The short-latency components consisted of four peaks. The early component around 3 ms, which was most prominent in A1-Cz, remained unchanged after muscle relaxation while the later peaks disappeared. Rostral transition of the stimulation resulted in an earlier shift of the early component. The estimated conduction velocity was 27.4 ± 10.2 m/s. Stimulation of the ansa cervicalis induced no EP.

CONCLUSIONS:

The early component was regarded as directly resulting from ascending neural conduction of A fibers of the VN, probably originating around the jugular foramen. Recording of VN-EP might document the cause of treatment failure in some patients.
Copyright © 2012 Elsevier Inc. All rights reserved.
PMID:
23088852
[PubMed - as supplied by publisher]

http://www.ncbi.nlm.nih.gov/pubmed/23088852

Tuesday, October 23, 2012

Vagus nerve stimulation in drug-resistant epilepsies. Analysis of potential prognostic factors in a cohort of patients with long-term follow-up.

2012 Oct 21. [Epub ahead of print]

Vagus nerve stimulation in drug-resistant epilepsies. Analysis of potential prognostic factors in a cohort of patients with long-term follow-up.

Source

Institute of Neurosurgery, Catholic University, Largo Agostino Gemelli, 8, 00168, Rome, Italy.

Abstract

BACKGROUND:

The results of vagus nerve stimulation (VNS) for the treatment of drug-resistant epilepsies are highly variable due to the lack of defined patient's selection criteria and a follow-up of published studies being generally too short. Here we report the outcome of VNS in a series with long-term follow-up and try to identify subgroups of patients who could be better candidates for this procedure.

METHOD:

We studied 53 patients (33 male, 20 female) with a prospectively recorded follow-up (mean, 55.96 ± 43.53 months). The monthly average seizure frequency for each patient at baseline, 3, 6, 12 months, and each year until the latest follow-up after implant was measured and the percentage of "responders" and response time (RT) were calculated. We investigated the following potential prognostic role of these factors: age of onset of epilepsy, pre-implant epilepsy duration, etiology, and age at implant.

RESULTS:

Globally, 40 % of patients responded to VNS (mean RT, 14.85 ± 16.85 months). Lesional etiology (p = 0.0179, logrank test), particularly ischemia (p = 0.011, Fisher exact test) and tuberous sclerosis (p = 0.0229, Fisher exact test), and age at implant <18 a="a" age="age" an="an" and="and" associated="associated" at="at" best="best" better="better" duration="duration" epilepsy="epilepsy" implant="implant" in="in" lesional="lesional" logrank="logrank" observed="observed" p="p" patients="patients" pre-implant="pre-implant" response="response" results="results" subgroup="subgroup" test="test" the="the" to="to" vns.="vns." were="were" with="with" years="years">

CONCLUSIONS:

The best candidate to VNS seems to be a patient with lesional etiology epilepsy (particularly post-ischemic and tuberous sclerosis) and a short duration of epilepsy who undergo VNS younger than 18 years.
PMID:
23086106
[PubMed - as supplied by publisher]

Related citations in PubMed


See reviews...See all...
 
http://www.ncbi.nlm.nih.gov/pubmed/23086106