A renewed web presence for cerbomed GmbH

Pressemitteilung von: cerbomed GmbH

(openPR) - ERLANGEN, Germany, March 8th, 2012 – The German medical device company cerbomed GmbH is re-launching its web site. At www.cerbomed.com patients and their families, as well as doctors, and medical specialists can access tailored information on transcutaneous Vagus Nerve Stimulation (t-VNS), using the device NEMOS. The new therapy alternative for difficult-to-treat epilepsies and depression will be available in Germany in summer 2012. The new web-presence marks cerbomed as a provider of innovative therapies. 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 NEMOS For t-VNS cerbomed developed and patented a special stimulator and a dedicated ear electrode. The stimulator, which is connected with the ear electrode, sends out the electrical impulses. With the transcutaneous vagus nerve stimulator NEMOS a targeted stimulation of the vagus nerve gets possible without the need of a surgery. The German market entry for NEMOS is planned for the third quarter of 2012. NEMOS will then be available for patients suffering from hard-to-treat epilepsies and depression. Cerbomed GmbH is an innovative medical device company that concentrates on researching, developing and producing new technologies and products for neuromodulation. The company’s focus is on transcutaneous Vagus Nerve Stimulation (t-VNS), which may offer an attractive therapy option for patients with hard-to-treat neurological and psychiatric illnesses. In 2011 cerbomed received the European clearance (CE mark) for the transcutaneous vagus nerve stimulator NEMOS. In early 2012 two more clinical studies will be starting regarding the effectiveness of t-VNS in patients with drug-resistant epilepsy and chronic migraine. cerbomed GmbH Dr. Martin Hyca, Director Marketing Henkestrasse 91 DE-91052 Erlangen +49 9131 9202 76 30 martin.hyca@cerbomed.com

http://www.openPR.com/news/213637/A-renewed-web-presence-for-cerbomed-GmbH.html

Behav Brain Res. 2012 Feb 28. [Epub ahead of print]

A scientist's dilemma: Follow my hypothesis or my findings?

Komisaruk BR.

Source

Department of Psychology, Rutgers, The State University of New Jersey, Newark, NJ 07102, United States.

Abstract

Over the course of my 50 years of brain-behavioral research, choicepoints presented themselves as to either follow my original hypothesis or follow my puzzling empirical findings. I trusted the latter more than the former because I believe it is where reality is to be found. Phil Teitelbaum's teachings had a major influence on those decisions. In the present essay, I describe the evolution of those choicepoints that led me from studies of hormone-brain-behavior interactions to a rhythmical brain-behavior connection, to sexual behavior, pain blockage, human brain-behavior interactions, and human brain imaging. Along this tortuous course, I learned that vaginal stimulation can block pain, the vagus nerve apparently can convey genital sensory activity to the brain, bypassing spinal cord injury, and all major brain systems evidently contribute to women's orgasm. An important message I learned is: pay attention to what you observe in your experiments, and have the courage to follow it up, particularly if what you observe is not what you were looking for…because it, rather than your hypothesis, is more likely to reveal reality.
Copyright © 2012. Published by Elsevier B.V.

PMID:

22394541

[PubMed - as supplied by publisher]

http://www.ncbi.nlm.nih.gov/pubmed/22394541

Brain stimulator helps slow man's Alzheimer's disease

Brain stimulator helps slow man's Alzheimer's disease

View larger image

For a man diagnosed with Alzheimer's disease six years ago, Robert Linton, is doing exceedingly well. Instead of struggling with becoming more forgetful, he is feeling great. And he believes it's all because of an experimental treatment that has slowed his disease.

View larger image In this image Robert Linton is seen. Linton is one of only six Alzheimer's patients in the world who has had an electrical stimulator implanted into his brain that appears to be keeping his memory healthy. View larger image Dr. Andres M. Lozano, left, sits next to patient Robert Linton as he demonstrates how electrodes are used to slow the progression of Alzheimer's disease through deep brain stimulation during a press conference at Toronto Western Hospital Wednesday, Aug. 4, 2010. (Darren Calabrese / THE CANADIAN PRESS)

Updated: Tue Mar. 06 2012 20:19:03

CTVNews.ca Staff

For a man diagnosed with Alzheimer's disease six years ago, Robert Linton, is doing exceedingly well. Instead of struggling with becoming more forgetful, he is feeling great. And he believes it's all because of an experimental treatment that has slowed his disease.

Linton is one of only six Alzheimer's patients in the world who has had an electrical stimulator implanted into his brain that appears to be keeping his memory healthy.

Robert, 66, is doing great though most with his brain disease might have been in a nursing home so many years after diagnosis. He still drives and has little trouble recalling the words he needs to complete a crossword puzzle.

Linton credits the device in his brain for keeping his memory healthy.

"I think it is the answer to Alzheimer's -- 100 per cent," he says.

• CTVNews.ca will host a live web chat Wednesday at 12 p.m. ET with Dr. Andres Lozano, neurosurgeon and scientist at the Krembil Neuroscience Centre, Toronto Western Hospital, along with fellow researcher Dr. David Tang-Wai, a neurologist in the Memory Clinic at the Krembil Neuroscience Centre, whose research focuses on Alzheimer's disease.

Four years ago, doctors at the Krembil Neuroscience Unit at Toronto Western Hospital drilled holes in Linton's skull and implanted two electrodes deep into his brain. The electrodes send out electrical bursts into the regions of Linton's brain that govern memories-- an area usually damaged by Alzheimer's.

The system is powered by a pacemaker-sized battery pack that sits under the skin of Linton's upper chest.

Neurosurgeon Dr. Andres Lozano implanted similar devices in five other patients as part of a study to determine whether brain stimulation can slow Alzheimer's progression. The research team has tracked the patients to see how their disease has progressed.

After two years, the team had the patients undergo a standard cognitive functioning test, known as the "mini-mental." In three of the patients, their test scores declined, suggesting the treatment hadn't worked. In two patients, their test scores remained the same, suggesting their disease has stabilized rather than worsened as one would expect.

In Linton's case, many of his Alzheimer's symptoms, such as his poor memory and problem solving skills, have actually improved -- much to the delight of doctors

"Rather than seeing a decline in his cognition and memory, we saw that he improved. That is exciting because it suggests maybe we are having an impact," says Dr. Lozano.

Linton himself has noticed it's easier to recall things since he had the stimulator implanted.

"If I want to remember something, I relax for a bit and it pops in," he says.

Linton's wife Barb says her husband's Alzheimer's isn't completely gone, but it isn't getting worse either.

"Whether (the treatment) slowed it or stopped it... we can only ask what would have happened had we not gone ahead with it," she says.

Robert is convinced the brain stimulator can take all the credit.

"I would have gradually declined and ended up in a nursing home. Yes, I think I see brighter worlds out there because of the operation," he says.

Doctors also performed MRI exams on the brains of the six patients. In most Alzheimer's patients, the areas of the brain controlling memory tend to shrink over time. But in Robert and another patient with early stage disease, the electrical stimulation appeared to have made the memory area of their brains grow.

It was a finding that surprised even Dr. Lozano.

"We are thrilled he is doing so well and we are trying to understand why is it he is doing so well," says Dr. Lozano.

Lozano speculates that the best candidates for the treatment may be those, like Linton, who are in the earliest stages of Alzheimer's disease. That way, the treatment can intervene before too much brain tissue has been lost to the disease.

It took Lozano's team 18 months to get ethics approval to conduct the small, Phase 1 trial of deep brain stimulation in Alzheimer's patients. The findings from that phase were published in the journal Annals of Neurology.

Lozano's team would now like to move to larger Phase 2 and Phase 3 trials, to test the technique in 40 to 50 patients, but they are still waiting for approval. Each phase of those trials would likely take about three years each, meaning wider availability of the treatment is likely still many years away -- assuming all goes well in those studies.

There are also questions about the costs of the procedure, and whether it's a feasible treatment for the broader population.

While there's much more work to be done, this research is an important first step for learning how to slow a disease with so few treatment options.

With a report from CTV's medical specialist Avis Favaro and producer Elizabeth St. Philip

http://edmonton.ctv.ca/servlet/an/local/CTVNews/20120306/alzheimers-deep-brain-stimulation-120306/20120306/?hub=EdmontonHome

Acta Neurol Scand. 2012 Feb 24. doi: 10.1111/j.1600-0404.2012.01656.x. [Epub ahead of print]

Application of a computational model of vagus nerve stimulation.

Helmers SL, Begnaud J, Cowley A, Corwin HM, Edwards JC, Holder DL, Kostov H, Larsson PG, Levisohn PM, De Menezes MS, Stefan H, Labiner DM.

Source

Department of Neurology, Emory University School of Medicine, Atlanta, GA, USA.

Abstract

OBJECTIVES:

The most widely used and studied neurostimulation procedure for medically refractory epilepsy is vagus nerve stimulation (VNS) Therapy. The goal of this study was to develop a computational model for improved understanding of the anatomy and neurophysiology of the vagus nerve as it pertains to the principles of electrical stimulation, aiming to provide clinicians with a systematic and rational understanding of VNS Therapy.

MATERIALS AND METHODS:

Computational modeling allows the study of electrical stimulation of peripheral nerves. We used finite element electric field models of the vagus nerve with VNS Therapy electrodes to calculate the voltage field for several output currents and studied the effects of two programmable parameters (output current and pulse width) on optimal fiber activation.

RESULTS:

The mathematical models correlated well with strength-duration curves constructed from actual patient data. In addition, digital constructs of chronic versus acute implant models demonstrated that at a given pulse width and current combination, presence of a 110-μm fibrotic tissue can decrease fiber activation by 50%. Based on our findings, a range of output current settings between 0.75 and 1.75 mA with pulse width settings of 250 or 500 μs may result in optimal stimulation.

CONCLUSIONS:

The modeling illustrates how to achieve full or nearly full activation of the myelinated fibers of the vagus nerve through output current and pulse width settings. This knowledge will enable clinicians to apply these principles for optimal vagus nerve activation and proceed to adjust duty cycle and frequency to achieve effectiveness.
© 2012 John Wiley & Sons A/S.

PMID:

22360378

[PubMed - as supplied by publisher]

http://www.ncbi.nlm.nih.gov/pubmed/22360378

Ann Neurol. 2012 Feb;71(2):157-68. doi: 10.1002/ana.22621.

Therapeutic devices for epilepsy.

Fisher RS.

Source

Department of Neurology and Neurological Sciences, Stanford University School of Medicine, Stanford, CA. robert.fisher@stanford.edu.

Abstract

Therapeutic devices provide new options for treating drug-resistant epilepsy. These devices act by a variety of mechanisms to modulate neuronal activity. Only vagus nerve stimulation (VNS), which continues to develop new technology, is approved for use in the United States. Deep brain stimulation of anterior thalamus for partial epilepsy recently was approved in Europe and several other countries. Responsive neurostimulation, which delivers stimuli to 1 or 2 seizure foci in response to a detected seizure, recently completed a successful multicenter trial. Several other trials of brain stimulation are in planning or underway. Transcutaneous magnetic stimulation (TMS) may provide a noninvasive method to stimulate cortex. Controlled studies of TMS are split on efficacy, which may depend on whether a seizure focus is near a possible region for stimulation. Seizure detection devices in the form of shake detectors via portable accelerometers can provide notification of an ongoing tonic-clonic seizure, or peace of mind in the absence of notification. Prediction of seizures from various aspects of electroencephalography (EEG) is in early stages. Prediction appears to be possible in a subpopulation of people with refractory seizures, and a clinical trial of an implantable prediction device is underway. Cooling of neocortex or hippocampus reversibly can attenuate epileptiform EEG activity and seizures, but engineering problems remain in its implementation. Optogenetics is a new technique that can control excitability of specific populations of neurons with light. Inhibition of epileptiform activity has been demonstrated in hippocampal slices, but use in humans will require more work. In general, devices provide useful palliation for otherwise uncontrollable seizures, but with a different risk profile than with most drugs. Optimizing the place of devices in therapy for epilepsy will require further development and clinical experience. Ann Neurol 2012;71:157-168.
Copyright © 2011 American Neurological Association.

PMID:

22367987

[PubMed - in process]

http://www.ncbi.nlm.nih.gov/pubmed/22367987

Neurosurg Focus. 2012 Mar;32(3):E13.

Brain stimulation for the treatment of epilepsy.

Fridley J, Thomas JG, Navarro JC, Yoshor D.

Source

Department of Neurosurgery, Baylor College of Medicine; and.

Abstract

The treatment of patients with refractory epilepsy has always been challenging. Despite the availability of multiple antiepileptic medications and surgical procedures with which to resect seizure foci, there is a subset of epilepsy patients for whom little can be done. Currently available treatment options for these unfortunate patients include vagus nerve stimulation, the ketogenic diet, and electric stimulation, both direct and indirect, of brain nuclei thought to be involved in epileptogenesis. Studies of electrical stimulation of the brain in epilepsy treatment date back to the early 20th century, beginning with research on cerebellar stimulation. The number of potential targets has increased over the years to include the hippocampus, subthalamic nucleus, caudate nucleus, centromedian nucleus, and anterior nucleus of the thalamus (ANT). Recently the results of a large randomized controlled trial, the electrical Stimulation of the Anterior Nucleus of Thalamus for Epilepsy (SANTE) trial, were published, demonstrating a significant reduction in mean seizure frequency with ANT stimulation. Soon after, in 2011, the results of a second randomized, controlled trial-the NeuroPace RNS trial-were published. The RNS trial examined closed-loop, responsive cortical stimulation of seizure foci in patients with refractory partial epilepsy, again finding significant reduction in seizure frequency. In the present review, the authors examine the modern history of electrical stimulation of the brain for the treatment of epilepsy and discuss the results of 2 important, recently published trials, the SANTE and RNS trials.

PMID:

22380854

[PubMed - in process]

http://www.ncbi.nlm.nih.gov/pubmed/22380854

Neurosurg Focus. 2012 Mar;32(3):E14.

Comparison of seizure control outcomes and the safety of vagus nerve, thalamic deep brain, and responsive neurostimulation: evidence from randomized controlled trials.

Rolston JD, Englot DJ, Wang DD, Shih T, Chang EF.

Source

Departments of Neurological Surgery and.

Abstract

Epilepsy is a devastating disease, often refractory to medication and not amenable to resective surgery. For patients whose seizures continue despite the best medical and surgical therapy, 3 stimulation-based therapies have demonstrated positive results in prospective randomized trials: vagus nerve stimulation, deep brain stimulation of the thalamic anterior nucleus, and responsive neurostimulation. All 3 neuromodulatory therapies offer significant reductions in seizure frequency for patients with partial epilepsy. A direct comparison of trial results, however, reveals important differences among outcomes and surgical risk between devices. The authors review published results from these pivotal trials and highlight important differences between the trials and devices and their application in clinical use.

PMID:

22380855

[PubMed - in process]

http://www.ncbi.nlm.nih.gov/pubmed/22380855