NECTAR-HF fails to demonstrate clinical benefit of vagus nerve stimulation in Heart Failure

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NECTAR-HF fails to demonstrate clinical benefit of vagus nerve stimulation in Heart Failure

Saturday, August 30, 2014

 

BARCELONA, Spain – Stimulating the vagus nerve, which regulates the body’s internal organ systems including the heart, does not improve cardiac function in heart failure patients, according to results of the NEural Cardiac TherApy foR Heart Failure (NECTAR-HF) trial.

NECTAR-HF was presented as a Hot Line today at ESC Congress 2014,  with simultaneous publication in the European Heart Journal.

The trial’s failure to show a cardiac benefit of vagal nerve stimulation (VNS) was unexpected, said study investigator Faiez Zannad, MD, PhD, from l’Institut Lorrain du Coeur et des Vaisseaux Louis Mathieu, in Vandoeuvre-lès-Nancy, France.

“There is robust pre-clinical data showing the benefit of VNS, but the NECTAR-HF trial failed to demonstrate a successful clinical translation of this protocol,” he said.

 

The study is the first randomised, controlled trial designed to evaluate the safety and efficacy of right-sided VNS.

It enrolled 96 heart failure patients from 24 centres across Western Europe to assess the impact of six months of VNS on cardiac function, as well as on cardiac biomarkers, exercise capacity, and quality of life.

Patients, who were about 59 years old and receiving optimal medical therapy, had the VNS device implanted in their neck, near the right vagus nerve, and connected to a pulse generator implanted under the skin of the chest.

After baseline testing of the system, patients were then randomized to either a control group in which the devices remained switched off, or an active VNS group in which the mean stimulation amplitude was 1.24 mA at the start of the study, and 1.42 mA at the 3-month follow-up visit.

After six months, the study found no difference in objective endpoints between the groups.
Both groups had comparable changes from baseline in the primary endpoint of left ventricular end-systolic dimension (LVESD),  as well secondary echocardiographic endpoints, exercise capacity, and levels of the heart failure serum biomarker N-terminal prohormone brain natriuretic peptide (NT-proBNP).

However, there were significant differences between the groups for three subjective endpoints related to quality of life.

Analyses of the Minnesota Living with Heart Failure Questionnaire (MLHFQ) and the Short Form 36 Health Survey (SF-36) demonstrated statistically significant improvement in quality of life with VNS treatment compared to controls (MLHFQ p=0.049; SF-36 Physical and Mental, p=0.02 and 0.24, respectively).

Additionally, 62% of patients in the VNS group had an improvement of at least one point from baseline in their New York Heart Association (NYHA) functional classification compared to only 45% of control patients (p=0.032).

“The safety profile for this application of VNS appeared acceptable, with an overall infection rate of 7.4%, which is comparable to that in patients implanted with a VNS system for the treatment of epilepsy,” noted Professor Zannad.

Given that preliminary studies suggested a benefit of VNS, there are a number of possible explanations for NECTAR-HF’s negative findings.

First, there is still much to learn about the appropriate dosing and technique of VNS. Data from epilepsy VNS studies show that higher-amplitude dosing might be more effective, but it is often not possible because it causes patient discomfort, said Professor Zannad.

Second, patients in the NECTAR-HF trial were relatively well-managed on medical therapy alone, making them perhaps not the best candidates to show a strong benefit of VNS.

Third, the six-month study period may have been too short to detect changes in cardiac function.

Although patients were blinded to their group assignment, meaning they were not told if they were receiving active treatment, it is possible that those in the active treatment group were able to feel the sensation of stimulation. If this was the case, patients could have been vulnerable to a placebo effect, knowing that they were receiving active therapy.
For this reason, the higher quality of life scores among VNS patients compared to controls should be interpreted with caution, he said.

Authors: ESC Press Office
For background information, please contact the ESC Press Office.
For independent comment on site, please contact the ESC Spokesperson coordinator.

Notes to editor
SOURCES OF FUNDING: The study was funded by Boston Scientific Corporation.
DISCLOSURES: Professor Zannad receives honoraria from Air Liquide, Bayer, Biomérieux, Biotronik, Boston Scientific, CVCRx, Janssen, Novartis, Pfizer, Resmed, Roche Diagnostics, Sanofi, Servier, St Jude, Takeda, speaker fees from Mitsubishi and owns stocks at CVCT and CardioRenal diagnostics. Co-author Gaetano De Ferrari receives honoraria from Amgen, Boston Scientific, Menarini and Merck. Co-authors Stephen Ruble, Doug Daum, Scott Meyer, Craig Stolen, Bernd Schubert, Agnes Ramuzat, Nicholas Wold and Kenneth Stein are employees of Boston Scientific Corporation.

About the European Society of Cardiology
The European Society of Cardiology (ESC) represents more than 80 000 cardiology professionals across Europe and the Mediterranean. Its mission is to reduce the burden of cardiovascular disease in Europe.
About ESC Congress 2014

The ESC Congress is currently the world’s largest international congress in cardiovascular medicine.  The spotlight of this year’s event is “innovation and the heart”.  ESC Congress 2014 takes place from 30 August to 3 September at the Fira Gran Via in Barcelona, Spain. For more information on ESC Congress 2014 contact the ESC Press Office.
To access all the scientific resources from the sessions during the congress, visit ESC Congress 365.

This press release accompanies both a presentation and an ESC press conference at the ESC Congress 2014. Edited by the ESC from material supplied by the investigators themselves, this press release does not necessarily reflect the opinion of the European Society of Cardiology. The content of the press release has been approved by the presenter.

http://www.healthcanal.com/blood-heart-circulation/heart-disease/54662-nectar-hf-fails-to-demonstrate-clinical-benefit-of-vagus-nerve-stimulation-in-heart-failure.html

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VNS Therapy for Depression – Are we really going to break the bank?

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Monday, August 25, 2014 12:55 AM
To: Madam Secretary Sylvia Matthews Burwell, United States Secretary of Health and Human Services
Subject: VNS Therapy for Depression – Are we really going to break the bank?

Dear Madam Secretary Burwell,

I am always trying to piece together little tidbits of information as I collaborate with another reasonably informed patient to ascertain the enormity of my advocacy for the VNS Therapy volunteer study subjects and patients implanted for depression before the CMS denial of May 4, 2007 that seek to continue with their therapy.  I’ve never received any answer to this question from the sponsor, Cyberonics, when I posed the question to them.  So I keep on searching and recently began to re-extrapolate some figures from the information that’s come available.

This past week I received a telephone call from a representative of CMS in which I asked were they busy helping VNS patients obtain insurance coverage.  The answer was “no”.  Then I quickly listened into the recording of Cyberonics financial teleconference of August 21, 2014.  With the help from this other VNS patient I learned there were two (2) occasions in the teleconference when the depression indication was mentioned.  One mark was at 21:30 minutes into the recording and the other at 45:30 minutes.  I learned there were 28 patients implanted with VNS Therapy for Depression in Cyberonics most recent reported financial quarter and in the prior quarter only 24 patients and as I vaguely recall in the quarter before that only 16.  Furthermore it was stated in this teleconference by the CEO, Mr. Daniel Moore, that they believed most all of these were “replacements”.  This slow increase may well correlate to or be attributed to my advocacy as patients learn that CMS has made some informal accommodations for the Medicare/Medicaid subscribers.

So if I used a number on the high-side such as 40 replacements a quarter that would represent about 160 patients that were benefiting from the therapy who want to continue with their therapy.  Therefore where I previously referred to the “enormity” of my advocacy it may simply boil down to about 160 to 200 patients who have responded to the therapy and achieved a significant degree of wellness and wish to continue.

Why continue this policy of not formally recognizing and caring for this aggrieved patient group through absolutely no fault of their own?  Recognize the serious error and oversight made by CMS and rightfully correct their mistake; now. 

These very, very long-time suffering depression patients have benefited from the VNS Therapy and wish to continue as well as maintain their wellness.  In the long-term it is a significant financial savings to CMS and the health insurers.

Once again, please issue a formal document (i.e. “Compassionate Use”) to insure their medical care now and into the future.  It is the right, humane and honorable thing to do.

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

vnsdepression@gmail.com

http://www.vnstherapy-herb.blogspot.com

http://www.vnstherapy.wordpress.com

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Harsh tone requires an apology

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Thursday, August 21, 2014 6:37 PM
To: Madam Secretary Sylvia Matthews Burwell, United States Secretary of Health and Human Services
Subject: Harsh tone requires an apology.

Dear Madam Secretary Burwell,

This past evening after emailing with Murray, a very dear and life-long friend, he had suggested I keep up my campaign to influence you and others in your administration to do the morally right thing while he also suggested toning down my rhetoric to you.

I am truly fortunate that many caring people read my missives and offer their thoughts and suggestions to help achieve our goals while at the same time emotionally sighting me on the objective.

If I’ve come off somewhat harsh in some of my words I do sincerely apologize.  

I understand that you do have a major governmental position and an enormous responsibility and that my issue and advocacy may seem minute in the scheme of things.  While our issue of VNS Therapy for the existing volunteer study subjects and patients implanted prior to CMS decision of May 4, 2007 may seem insignificant as compared to many of your other issues and challenges the fact is this group of patients has been egregiously wronged and harmed by those responsible within CMS to not have grandfathered and considered the medical needs and health insurance coverage for their care in that decision.  CMS cut off medical insurance coverage for medical devices already implanted into real-live-patients.  That decision also let the private health insurers off the hook whereas CMS has since partially made a make-shift effort to help the Medicare/Medicaid patients.

Please take a moment to think if it were your Mom or Dad, spouse or child or sibling implanted with a medical device and then you learn that the medical insurance you pay religiously will not cover your loved ones.  I’m sure you too would be agitated and fiercely advocating.

Only I’ve been at this advocacy for more than seven (7) years and prior to CMS denied coverage.  Actually my advocacy goes back half century when advocating for parity in mental health.  As my spouse Joyce was one of the earliest volunteer study subjects for VNS Therapy for depression I also recognized the potential loophole and conundrum in insurance coverage pending the denial from CMS.  At that time I conversed several times with the former CEO of Cyberonics, Mr. Skip Cummins, to share my thoughts and alert him to the predicament the study subjects were potentially facing.

As I am doggedly hounding you and advocating for these patients so too did I similarly direct my attention and efforts toward Mr. Cummins.  He assured me not to worry and then publicly issued the following corporate press release on January 18, 2006:  “Lifetime Reimbursement Guarantee for All TRD IDE Study Patients”

As it more recently evolved the current CEO, Mr. Daniel Moore, reneged on this guarantee citing federal kickback statues.

So here I am still bucking my head against all these bureaucracies trying to get department heads/bosses/CEO to act humanely and to do what is morally right. 

Joyce will need another replacement device in about 8 years.  I do not want to have to go through this same struggle to get her health insurer to cover her replacement or that of the other patients.  At the same time I want to pressure the private insurers to cover their already implanted patients and I can only do so with your help and assistance.

Again, I am asking for a moment of your time to issue a formal document (i.e. Compassionate Use) or some other instrument signed by you that will formalize and establish the rightful care for these patients, once and for all.

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

vnsdepression@gmail.com

http://www.vnstherapy-herb.blogspot.com

http://www.vnstherapy.wordpress.com

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NOTICE OF CONFIDENTIALITY / Disclaimer

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Disclaimer: This E-Mail is covered by the Electronic Communications Privacy Act, 18 U.S.C. §§ 2510-2521 and is legally privileged. The information contained in this E-Mail is intended only for use of the individual or entity named above. If the reader of this message is not the intended recipient, or the employee or agent responsible for delivering it to the intended recipient, you are hereby notified that any dissemination, distribution, or copying of this communication is strictly prohibited. If you receive this E-Mail in error, please notify the sender immediately at the email address and/or phone number above and delete the information from your computer. Please do not copy or use it for any purpose nor disclose its contents to any other person.

CONFIDENTIALITY NOTICE: This e-mail message including attachments, if any, is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail, destroy all copies of the original message, and do not disseminate it further. If you are the intended recipient but do not wish to receive communications through this medium, please advise the sender immediately.

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How to Tell If Your Health Insurance Covers Mental Health Treatment

How to Tell If Your Health Insurance Covers Mental Health Treatment

 

Pending approval Elizabeth Renter

 

8/21/14 2:00pm 41 minutes ago

 

How to Tell If Your Health Insurance Covers Mental Health TreatmentExpand

For some, the stigma associated with mental illness keeps them from seeking help, but others may be avoiding treatment simply because they are unsure of whether they can afford it or whether their health insurance covers it.

This post originally appeared on Nerdwallet.

Each year, more than 5 million American adults experience a major depressive episode and do not seek treatment, according to a recent NerdWallet study. While insurance coverage for mental health treatment is more widely available and comprehensive thanks to recent changes, some say it still doesn’t go far enough.


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If you purchased your health insurance through state exchanges set up by the Affordable Care Act, mental health care is covered. It is one of the ten benefits that must be covered on all plans under the law. If you have insurance through your employer, there’s a pretty good chance you’re covered, too. A Society for Human Resource Management survey of 2014 employee benefits found that 87% of employer health plans cover mental health treatment. But exactly what mental health services are covered under these plans varies and depends on what medical services are covered.

Mental Health Parity Law

Historically, mental health coverage had been treated as a less important health concern than medical coverage by the insurance industry. That has changed over the years, culminating with the passage of the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act in 2008. Also referred to as the mental health parity law, the act essentially mandates mental health and substance abuse coverage to be comparable to physical health coverage.

“New efforts are underway to expand coverage to the millions of Americans who have lacked access to affordable treatment for mental and substance use disorders,” said Labor Secretary Thomas Perez, upon passage of the final parity rules. “These rules will increase access to mental health and substance abuse treatment, prohibit discriminatory practices and increase health plan transparency. Ultimately, they’ll provide greater opportunities for affordable, accessible, effective treatment to Americans who need it.”

The parity law says that insurance policies covering mental health care must treat that care as they do other medical coverage. If you generally pay a $40 copay for doctor’s appointments and treatments, for instance, an appointment with your psychologist can’t carry a higher price tag.

Before the final rules of the parity law took effect, patients in need of mental health treatment would often have to seek pre-approval for coverage, and even then, they would be limited to a certain number of visits per year. That is no longer the case. Though health insurance companies can always review whether covered treatments are necessary, they can no longer put arbitrary caps on mental health visits that they wouldn’t put on medical appointments.

Depending on the specifics of your policy, and whether similar medical treatments are covered, your mental health coverage can include: emergency room visits, hospital stays, individual and group therapy appointments, psychiatrist visits and coverage for mental health prescriptions.


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Plans Still Not Required to Have Mental Health Coverage

“The parity law, on paper, certainly appears to be an improvement in health care policies”, says Lisa Blackstock, a patient advocate from Soul Sherpa. “The key is whether or not your policy covers [mental] health care.”

The law does increase the quality of care for those who have mental health coverage, but it does not mandate mental health coverage on all policies. Instead it requires health insurance plans that do cover mental health treatment to cover it on par with medical treatment. The American Psychological Association points out there are some programs exempt from the parity law. Some state government employee plans can opt out of parity requirements. Likewise, Medicare is not subject to the law.

Even if mental health coverage is available, some providers may not accept your insurance. Blackstock told NerdWallet that mental health providers are often reluctant to accept these policies because reimbursement rates are so low.

If you are unclear about your coverage, consult your description of plan benefits or contact your insurance carrier directly.

Deductibles and Copays Still Apply

The parity law, along with requirements under the ACA, may mean mental health care is more accessible than ever. But that doesn’t mean there aren’t costs. Just like your medical care, mental health care is subject to copays, coinsurance, deductibles and other out-of-pocket costs. It is likewise still subject to coverage denials from insurance companies.

You can prepare for these costs by becoming familiar with your plan’s coverage specifics before you seek mental health treatment. If you receive an unexpected denial or higher-than-anticipated bills after treatment, you may find help through a medical bill advocate.

Blackstock says patients with mental health questions shouldn’t be afraid to get help.

“My advice to all persons regarding emotional well-being and mental health is to maintain a strong support group, be open when stress gets to be too much, and don’t be hesitant to appoint an agent for you in your advance health care directive who you can trust to help navigate your care when the going gets tough,” Blackstock says. “If you incur a big bill for mental health treatment that isn’t covered by insurance, find a patient advocate with a proven track record in bill negotiation […] Someone needs to pick it apart and aggressively advocate on your behalf, not unlike an attorney or realtor doing their job in their respective fields.”

Does My Health Insurance Cover Mental Health Treatment? | Nerdwallet

http://www.nerdwallet.com/blog/health/2014/08/18/health-insurance-cover-mental-health-treatment/


Nerdwallet offers data-driven tools and impartial information to help you make solid decisions about the money you work hard to earn. In short, we do the homework so you don’t have to.

Image adapted from Lightspring (Shutterstock).

Want to see your work on Lifehacker? Email Andy.

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Message About Tragic Passing of Robin Williams

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Wednesday, August 20, 2014 3:38 AM
To: Madam Secretary Sylvia Matthews Burwell, United States Secretary of Health and Human Services
Subject: Message About Tragic Passing of Robin Williams

Dear Madam Secretary Burwell,

“Unfortunately, every day over 100 Americans die as a result of suicide.” — Jeffrey Borenstein, M.D., President & CEO, Brain & Behavior Research Foundation

Just what does it take for you and your cadre of subordinates to understand that there are a number of VNS Therapy volunteer study subjects and patients who have finally achieved a degree of wellness and wish to continue doing so if not for the obstacles your organization and the health insurance industry has put before them.

I have previously laid out before you that the CMS decision of May 4, 2007 was careless, ignorant, stupid, egregious, unconscionable and criminal by overlooking care for the existing patients and especially for those having benefited from the VNS Therapy and wishing to continue with the therapy.  Judge John Smith’s decision further justifies this position.

How many more individuals have to be added to Dr. Borenstein’s list of “Americans die as result of suicide”?  Does the buck not stop at your desk?  Are you not the “boss”?

Again, I am asking you for a formal document be signed to protect this patient population to insure that they have access to and obtain medical health insurance coverage.  I am also asking for your office to influence the private health insurance companies to similarly follow suit.

This issue has drawn on since May 4, 2007.  These patients have been seriously wronged like no other by the short-sightedness of CMS.  Is it not time to right this harmful wrong?  Please act now. 

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

vnsdepression@gmail.com

http://www.vnstherapy-herb.blogspot.com

http://www.vnstherapy.wordpress.com

———- Forwarded message ———-
From: The Brain & Behavior Research Foundation <enews@bbrfoundation.org>
Date: Wed, Aug 13, 2014 at 1:03 PM
Subject: Message About Tragic Passing of Robin Williams
To: Herbert <vnsdepression@gmail.com>

 

View this email in your browser

clip_image002

Dear Foundation Supporters,I am saddened by the very tragic passing of Robin Williams. Unfortunately, every day over 100 Americans die as a result of suicide. The national conversation in the media about Robin Williams will hopefully encourage people to seek treatment and not suffer in silence. I also hope that the media attention will reduce stigma and encourage increased support for research to develop new methods of treatment of brain disorders. I had the privilege of representing our Foundation and joining the national conversation about suicide and suicide prevention. Please see the links to the CBS Evening News, WPIX News, and Bloomberg article.
Thank you for your ongoing commitment to the Brain & Behavior Research Foundation. Please help the families of today and tomorrow by SUPPORTING brain research.
Better treatments and breakthroughs come from scientific discovery.
With warmest regards and appreciation,
Jeffrey Borenstein, M.D.
President & CEO
Brain & Behavior Research Foundation


Read an article from Bloomberg.com.

bbrfoundation.org

 

Copyright © 2014 Brain & Behavior Research Foundation, All rights reserved.
You are receiving this email because you joined our eNews mailing list.
Our mailing address is:

Brain & Behavior Research Foundation

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Disclaimer: This E-Mail is covered by the Electronic Communications Privacy Act, 18 U.S.C. §§ 2510-2521 and is legally privileged. The information contained in this E-Mail is intended only for use of the individual or entity named above. If the reader of this message is not the intended recipient, or the employee or agent responsible for delivering it to the intended recipient, you are hereby notified that any dissemination, distribution, or copying of this communication is strictly prohibited. If you receive this E-Mail in error, please notify the sender immediately at the email address and/or phone number above and delete the information from your computer. Please do not copy or use it for any purpose nor disclose its contents to any other person.

CONFIDENTIALITY NOTICE: This e-mail message including attachments, if any, is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply e-mail, destroy all copies of the original message, and do not disseminate it further. If you are the intended recipient but do not wish to receive communications through this medium, please advise the sender immediately.

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The re-organization of functional brain networks in pharmaco-resistant epileptic patients who respond to VNS.

Neurosci Lett. 2014 Aug 11. pii: S0304-3940(14)00651-X. doi: 10.1016/j.neulet.2014.08.010. [Epub ahead of print]

The re-organization of functional brain networks in pharmaco-resistant epileptic patients who respond to VNS.

Fraschini M1, Demuru M2, Puligheddu M3, Floridia S2, Polizzi L4, Maleci A3, Bortolato M5, Hillebrand A6, Marrosu F7.

Author information
  • 1Dipartimento di Ingegneria Elettrica ed Elettronica, Università di Cagliari, Italia. Electronic address: fraschin@unica.it.
  • 2Dipartimento di Ingegneria Elettrica ed Elettronica, Università di Cagliari, Italia.
  • 3Dipartimento di Sanità Pubblica, Medicina Clinica e Molecolare, Università di Cagliari, Italia.
  • 4Azienda Ospedaliero Universitaria di Cagliari, Italia.
  • 5Department of Pharmacology and Toxicology, School of Pharmacy, University of Kansas, Lawrence (KS), USA.
  • 6Department of Clinical Neurophysiology and Magnetoencephalography Center, Neuroscience Campus Amsterdam, VU University Medical Centre, Amsterdam, The Netherlands.
  • 7Dipartimento di Sanità Pubblica, Medicina Clinica e Molecolare, Università di Cagliari, Italia; Azienda Ospedaliero Universitaria di Cagliari, Italia.
Abstract

Vagal nerve stimulation (VNS) is a therapeutic add-on treatment for patients with pharmaco-resistant epilepsy. The mechanism of action is still largely unknown. Previous studies have shown that brain network topology during the inter-ictal period in epileptic patients deviates from normal configuration. In the present paper, we investigate the relationship between clinical improvement induced by VNS and alterations in brain network topology. We hypothesize that, as a consequence of the VNS add-on treatment, functional brain network architecture shifts back towards a more efficient configuration in patients responding to VNS. Electroencephalographic (EEG) recordings from ten patients affected by pharmaco-resistant epilepsy were analyzed in the classical EEG frequency bands. The phase lag index (PLI) was used to estimate functional connectivity between EEG channels and the minimum spanning tree (MST) was computed in order to characterize VNS-induced alterations in network topology in a bias-free way. Our results revealed a clear network re-organization, in terms of MST modification, towards a more integrated architecture in patients responding to the VNS. In particular, the results show a significant interaction effect between benefit from VNS (responders/non-responders) and condition (pre/post VNS implantation) in the theta band. This finding suggests that the positive effect induced by VNS add-on treatment in epileptic patients is related to a clear network re-organization and that this network modification can reveal the long debated mechanism of action of VNS. Therefore, MST analysis could be useful in evaluating and monitoring the efficacy of VNS add-on treatment potentially in both epilepsy and psychiatric diseases.

Copyright © 2014. Published by Elsevier Ireland Ltd.

KEYWORDS:

EEG; Epilepsy; Functional Network; Minimum spanning tree; PLI; Theta Band; Vagal Nerve Stimulation

PMID:
25123446
[PubMed - as supplied by publisher]

http://www.ncbi.nlm.nih.gov/pubmed/25123446

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"Parkinson’s and depression can go hand in hand"

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Thursday, August 14, 2014 7:30 PM
To: Madam Secretary Sylvia Matthews Burwell, United States Secretary of Health and Human Services
Subject: “Parkinson’s and depression can go hand in hand”

Dear Madam Secretary Burwell,

Early on in a number of my messages to your predecessor Kathleen Sebelius, Jonathan Blum – CMS, medical professionals and Joyce’s fellow patients I shared my interesting and unique observations that despite worsening of Joyce’s Parkinson’s type illness, PSP (Progressive Supranuclear Palsy), she continues to remain depression free.  In Joyce’s case history there is no doubt in my mind that I attribute this unique and amazing benefit to her VNS Therapy. 

The point being Madam Secretary that information of this nature does not appear in the data contained in the computers that your medical experts ruminate as to safety and efficacy of VNS Therapy for Depression.  In my spouse’s case 14 years of therapy have exhibited no safety issues and efficacy has been nothing short of remarkable.  The fact is there is a group of volunteer study subjects and patients implanted with this medical device similarly benefiting from the therapy despite whatever incorrect conclusions your staff may have arrived at.  The reality is their facts are skewed and/or misinterpreted and do not match real world results.  And even if the percentage obtaining efficacy are not up to your medical staffs criteria the most important point your people are missing is that these are the worst of the worst patients, like Robin Williams experiencing suicidal ideations, who have found a treatment that finally works for them.

Robin Williams’s death is a tragedy from my perspective as is the suicide of others who lack information and awareness of many newer treatment options.  The fact is no one can guarantee the efficacy of any therapy for severe depression patients but to deny a VNS Therapy patient a treatment option that is already beneficial and working for the patient is truly inhumane and criminal.  And that is exactly what CMS has done through their blatant ignorance and/or professional arrogance and so too the private health insurers that followed CMS lead.  Whether through oversight or stupidity you have left this group of patients without medical coverage for therapy that has remarkably benefited their lives like no other.

Again I am asking you to abort this lunacy.  Issue a formal document (i.e. “Compassionate Use”) to insure medical care for the existing patients and help put similar pressure on the private health insurers to follow suit and abort their arrogance too.

Sincerely,

Herb

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

vnsdepression@gmail.com

http://www.vnstherapy-herb.blogspot.com

http://www.vnstherapy.wordpress.com

Robin Williams suffered from early Parkinson’s at death: widow

By Piya Sinha-Roy and Eric Kelsey

LOS ANGELES Thu Aug 14, 2014 5:54pm EDT

3 Comments

·

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A woman takes a picture of a mural depicting late actor Robin Williams in Belgrade, August 13, 2014.

Credit: Reuters/Marko Djurica

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· Entertainment »

· People »

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LOS ANGELES (Reuters) – Robin Williams was sober but suffering from the early stages of Parkinson’s disease as well as severe depression and anxiety at the time of his apparent suicide, the actor’s widow said in a statement on Thursday.

Susan Schneider said Williams “was not yet ready to share publicly” his struggles with Parkinson’s, an incurable and debilitating nervous system disorder that causes tremors and slowness of movement.

“It is our hope in the wake of Robin’s tragic passing, that others will find the strength to seek the care and support they need to treat whatever battles they are facing so they may feel less afraid,” Schneider said in the statement.

The 63-year-old Oscar-winning comedic virtuoso, whose madcap style and dramatic versatility made him one of film and television’s top stars, was found hanged at his Tiburon, California, home north of San Francisco on Monday.

The news that the comedian also suffered Parkinson’s disease has drawn attention to the correlation between the disorder and depression.

“While a diagnosis of any serious disease can be overwhelming, Parkinson’s and depression can go hand in hand,” the National Parkinson Foundation said in a statement following Schneider’s announcement.

“Depression affects quality of life more than the motor impairments of the disease,” the foundation said, adding that more than half of those who suffer from Parkinson’s also experience clinical depression as part of the disease.

Actor Michael J. Fox, boxer Muhammad Ali and singer Linda Ronstadt have all be diagnosed with Parkinson’s. Ronstadt said last year that the disease had robbed her of her singing voice.

Between 50,000 and 60,000 people are diagnosed with Parkinson’s each year in the United States. It typically affects people over 50 years old.

Williams, whose starring roles included “Mrs. Doubtfire” and “Good Will Hunting,” had been open about his struggles with alcohol and had gone to a Minnesota rehabilitation center this summer to “fine-tune” his sobriety, his publicist said in July.

Friends of the comedian, who first shot to prominence as a friendly alien in late 1970s TV series “Mork & Mindy,” described Williams as a man who masked his depression and thrived from performing for a crowd.

Williams’ death, which has touched off a national conversation about suicide and depression, shook Hollywood and generations of fans.

U.S. President Barack Obama called him a “one of a kind” actor while directors and colleagues noted his humble nature, generosity and talent as one the most inventive comedians of his era.

“Since his passing, all of us who loved Robin have found some solace in the tremendous outpouring of affection and admiration for him from the millions of people whose lives he touched,” Schneider said.

“His greatest legacy, besides his three children, is the joy and happiness he offered to others, particularly to those fighting personal battles,” she added in the statement.

Funeral arrangements are pending, and a full toxicology report will take two to six weeks, local officials said.

(Editing by Jonathan Oatis)

http://www.reuters.com/article/2014/08/14/us-people-robinwilliams-idUSKBN0GE1YQ20140814

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