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

Thursday, March 28, 2013

MSU Professor on Lies and the Human Brain

MSU Professor on Lies and the Human Brain

Julian Keenan of Montclair State University’s Biology and Psychology departments talks about research and how parts of the brain can be turned off to prevent lying.

Whether you are young or old, everyone tells lies in one way or another on a daily basis.
Of course, there are all sorts of different lies — white lies, exaggerations, delusions, deceptions — and some are worse than others. But regardless of the what kind of lie it is, the same parts of the brain are used in manufacturing the fabrication.

As April Fool’s Day approaches, Montclair Patch decided to talk with professor Julian Keenan of Montclair State University’s Biology and Psychology departments about the science of lies.

A portion of the conversation is below.

What kind of research have you done on the topic of lying?
Keenan: We are looking at what areas of the brain are involved in deception, and the lying we are most interested in is the lying people do to themselves or what goes on in your brain when you are telling yourself that you are better than you are, smarter than you are, funnier than you are.

So you can see specific parts of the brain becoming active when someone is telling a lie?
Keenan: Yes, but unfortunately the brain works like that for a lot of different things. So at Montclair State, we use a machine called transcranial magnetic stimulation, or TMS, which is able to block certain types of the brain from functioning for a brief amount of time — a fraction of a second.
So we ask people questions and ask them to lie. If we are focusing on the right part of the brain using TMS, they won’t be able to lie.

How then do you turn those parts of the brain off?
Keenan: This is the part where people really become interested.

The TMS machine is placed up against the skull and you can target a part of the brain as small as 1 centimeter by 1 centimeter. It turns off parts of the brain by creating a magnetic field and makes all the cells in that small area of the brain work at once. When all the cells work at once, they don’t work at all, which creates a virtual lesion.

The uses for TMS seem ideal for interrogations and intelligence gathering, no?
Keenan: I could care less about that stuff, but yes, some people are using TMS for interrogation purposes.

Is the technology being used widely by law enforcement? 
Keenan: It is being used widely. The problem is that it is not reliable enough, and not immiscible in court.

What else have you found in your research about lying?
Keenan: People love to tell themselves lies. We found what people throughout time have found: People lie to themselves all the time. The brain is not very concerned with reality; the brain is concerned about making you feel better.

Is it natural for us to lie then?
Keenan: Absolutely. Lying is healthy and a sign of high intelligence.

Kids are lying by the age of 2. And while 2-year-olds are horrible liars, kids usually begin lying well enough to get away with it by the age of 5.

Is lying tied to self-esteem then?  
Keenan: Yes. The more we lie to ourselves, the better we feel.

People with clinical depression are more based in reality than people without depression, because they see the world as it really is by lying to themselves less.

MRI-guided brain surgery easier on Parkinson’s patients


MRI-guided brain surgery easier on Parkinson’s patients

Published March 25, 2013
For patients with advanced Parkinson’s disease, getting deep brain stimulation, a sort of “pacemaker” for the brain, can dramatically reduce their debilitating symptoms, including tremors, rigidity, stiffness, slowed movement and walking problems.

Since 2002, more than 70,000 patients have undergone deep brain stimulation (DBS) surgery to treat their symptoms.

Yet, the brain surgery is about eight hours long and difficult for patients, who have to be awake through some of the operation. Not only that, but Parkinson’s patients have to go off their medications before the surgery, often causing them much pain and discomfort.

“The thought of being awake and having brain surgery is stressful for patients,” said Dr. Hooman Azmi, director of the division of movement disorders at Hackensack University Medical Center in New Jersey. “I’ve had patients who are just so worried about it that they don’t want the surgery or there are patients that just never go to surgeons because of these fears."

Over the last two years, brain surgeons have begun using a new computer-driven surgical system to reduce these drawbacks of the surgery and to improve the accuracy of the procedure. The new system, called ClearPoint, uses magnetic resonance imaging (MRI) during the surgery (it’s done in the MRI suite, not the OR) to precisely pinpoint the target for the pacemaker in real time.

Traditionally, the surgery is done through a small burr hole and is based on images taken before surgery and “stereotactic” techniques, which provide a 3-D coordinate system and brain mapping to help hit the target as precisely as possible. A “lead” or thin, insulated wire is implanted in the brain and the tip of the wire is within the targeted area, which is about the size of a pea (the battery pack is typically implanted under the skin near the collarbone).

“The benefits of the surgery depend on how accurately we place it, and the side effects depend on our accuracy as well,” Azmi said.

Because the brain can shift ever so slightly, surgeons need the patient’s feedback from the electrical activity of the brain to be sure they’ve hit their target—that’s why patients need to be woken up during the surgery. The operation can take eight hours because it requires extensive brain mapping and waking the patient out of their anesthesia. The reason patients have to go off their medications is because the drugs mask the symptoms. Surgeons need patients to experience the symptoms in order to tell if the DBS wire is accurately positioned to reduce them.

With ClearPoint, the surgeon uses MRI images taken during surgery to visualize the brain and see the precise target during the surgery. Because of this precision, there’s no need to wake the patient during surgery and patients can stay on their medications because the surgeon no longer needs to “test” whether they’ve hit their target.   The procedure takes about half the time.

“Surgery is safer because it’s shorter; the patient is more comfortable, (and) we can see the wires going in," Azmi said.  "If there’s any bleeding we could see it."

The system, which is being used in 18 medical centers in the U.S., can also be used to treat other movement disorders treated by DBS such as essential tremors and dystonia, which causes muscle contractions.

Tuesday, March 26, 2013

Noninvasive, Hand-held Device Promising for Migraine

Noninvasive, Hand-held Device Promising for Migraine

Caroline Cassels

Mar 26, 2013
San Diego, California — Noninvasive vagus nerve stimulation (nVNS) using a portable, hand-held device may offer an effective, well tolerated, and safe treatment for acute migraine, preliminary research suggests.

A small, open-label pilot study conducted by investigators at the University of Southern California San Francisco (UCSF) showed nVNS reduced pain and increased pain-free status in a group of migraine patients with, and without, aura.

According to principal investigator Peter Goadsby, MB, BS, although the findings are preliminary, they offer the hope of an effective treatment without many of the adverse effects associated with current migraine treatments, which include triptans, ergotamine, antiepileptics, and antidepressants.
In addition, he noted, over the past 5 to 7 years there has been a trend toward developing neuromodulation treatments with implantable devices. He added that if it proves effective, this hand-held, portable, and noninvasive modality would be a step up.

"The nice thing about external devices is if they don't work [the patient] can give them back and you don't have to do anything complex. One of the problems we have with internal devices at the moment is that they are expensive to do, they're relatively invasive and things can go wrong — not big things, but still.

"If you give me a device that can help 20% of my patients then will be a happy man, particularly if I don't do any harm to any of them," Dr. Goadsby told delegates here at the American Academy of Neurology (AAN) 65th Annual Meeting.

Dr. Goadsby, who is director of UCSF's Headache Center, said the move to develop noninvasive neuromodulation approaches came from a number of clinical observations, the seminal one being the case of a young man who was treated with a VNS implant for intractable epilepsy.
The treatment failed to control his seizures, but clinicians noted that he became migraine free. The report was published in 2002 in Cephalagia.

For the pilot study the investigators recruited 30 patients — 25 females and 5 males — with a median age of 39 who had episodic migraine with and without aura.

Patients were asked to treat 3 attacks over the 6-week study period. The treatment consisted two 90-second doses at 15-minute intervals delivered to the right cervical branch of the vagus nerve. Patients were asked to self-treat once pain became moderate severe or after 20 minutes of mild pain.

Essentially, said Dr. Goadsby, the device was placed on the right side of the neck, and a thumbwheel allowed patients to turn the electrical stimulator up or down.

Three of the study participants experienced no attacks, so the final analysis was based on 27 patients and 84 treated attacks.

Data for the first attack among patients with moderate and severe pain showed that 4 of 19 patients (21%) were pain free at 2 hours and 8 of 19 (42%) had pain relief that decreased to nil or mild at 2 hours.

Results for those with mild pain at first attack showed 5 of 8 (63%) were pain free at 2 hours.
When researchers examined the effect of the device on all migraine attacks, they found that 12 of 55 (22%) patients with moderate to severe migraine and 10 of 26 (38%) with mild migraine were pain free at 2 hours.

Mild, Infrequent Adverse Effects
Adverse events were infrequent and mild and included neck twitching (n = 3), raspy voice (n = 1), and neck redness (n = 1).

Dr. Goadsby noted that the sensation patients experience from the device is not pleasant but also not unpleasant.

These findings, he said, warrant further investigation in randomized, placebo-controlled trials and added that a sham device is being developed.

Future studies of the device will examine whether there are treatment differences between the right and left sides of the neck, as well as the treatment durability.

Noninvasive neuromodulation, said Dr. Goadsby, has much to offer migraineurs.

"If we can develop noninvasive treatments for even a small group of patients that would be a helluva step forward," he said.

Warrants Further Study
Commenting on the study for Medscape Medical News, Tobias Kurth, MD, director of research, Institut national de la santé et de la recherche médicale (INSERM), University of Bordeaux, Talence, France, and associate epidemiologist, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, agreed that the data are "convincing enough to warrant further study."

"If this turns out to be an effective treatment it would add to the treatment options for migraine with a device that is almost free of side effects," said Dr. Kurth.

He noted that about 30% of migraineurs do not respond to therapy and so novel treatment approaches are urgently needed.

Dr. Kurth added that although invasive neurostimulation for severe migraine has demonstrated some benefit, he remains unconvinced that it is a good treatment option for even in this severely affected population.

On the basis of the data at this point, he said, in his opinion it should be considered a "last resort" treatment in severely affected patients for whom nothing else has worked.

On the other hand, by eliminating the need for surgery and its related risks and adverse effects, nVNS may have potential as a viable treatment option for at least a proportion of patients with migraine, he added.

"It will not be for everybody for sure but even if it works for a small fraction of patients for whom no other medication seems to work this would be a huge success," said Dr. Kurth.

Dr. Goadsby reports he has received $2000 in direct compensation related to the presentation from the device manufacturer. Funding from the study came from multiple sources, most prominently from the Sandler Family Trust and the Department of Defense. Dr. Goadsby also reports the device manufacturer had no role in the study's data collection or analysis. Dr. Kurth has disclosed no relevant financial relationships.
American Academy of Neurology (AAN) 65th Annual Meeting. Abstract S40.004. Presented March 20, 2013.

Monday, March 25, 2013

Cyberonics Says Former Employee Dismisses Suit

  • February 4, 2013, 12:01 p.m. ET

  • Cyberonics Says Former Employee Dismisses Suit

    By Anna Prior 
    Cyberonics Inc. (CYBX) said a former employee voluntarily dismissed without prejudice a lawsuit he filed against the medical-device maker in a Massachusetts federal court.

    The employee, former sales representative Andrew Hagerty, had previously filed a wrongful termination suit against the company in which he raised questions about the legality of Cyberonics sales and marketing practices.

    The lawsuit had raised "the potential for this case broadening to something larger" like a qui tam, or "whistleblower" suit, Jefferies analyst Raj Denhoy said in a note to clients.

    Shares of the medical-device maker recently rose 8.4% to $48.08.

    While the employee's "motivation for dismissal of the wrongful termination suit is unknown, the move nonetheless removes a major overhang" on Cyberonics' stock, Mr. Denhoy said as he reiterated a buy rating on the stock.

    In January, a short-seller's report discussed the lawsuit in its criticism of Cyberonics, sending shares tumbling on heavy volume.

    The company responded to those allegations, declining to comment on the suit and disputing the short-seller's criticism of the company's implantable device used to treat epilepsy and depression.
    On Monday, Cyberonics said that under the terms of Mr. Hagerty's employment, his claims are subject to binding arbitration and Mr. Hagerty has the right to re-file the lawsuit or to purse a resolution through binding arbitration.
    Write to Anna Prior at

    Study Participants Experienced Improvement in Pain and Well-Being that Persisted Through One Year

    PR Newswire: news distribution, targeting and monitoring 2013
    NeuroStar TMS Therapy, a Non-Drug Depression Treatment, Demonstrates Statistically Significant Benefits on Patient-Reported Pain Outcomes  

    Study Participants Experienced Improvement in Pain and Well-Being that Persisted Through One Year

    SAN DIEGO, March 19, 2013 /PRNewswire/ -- New data released today at the annual meeting of the American Academy of Neurology show that transcranial magnetic stimulation (TMS) administered using the NeuroStar TMS Therapy System® significantly reduced pain-related symptoms in patients with Major Depressive Disorder (MDD), with improvement sustained through one year.  Pain-related symptoms are present in more than 75 percent of patients living with depression, indicating a need to offer patients effective treatment options.
    "A majority of people living with depression experience pain-related symptoms, which often interfere with patients' quality of life and may result in greater treatment costs," said Dr. Mark George , M.D., Director of the Brain Stimulation Laboratory at the Medical University of South Carolina. "The data in this preliminary study indicate that TMS may serve as a promising, effective, non-drug option to relieve symptoms of moderate to extreme pain in patients with MDD without the systemic side effects of oral medications."  
    In this subset analysis of a Neuronetics-sponsored multisite, naturalistic, observational study involving 42 TMS clinical practice sites based in the United States, 307 outpatients with a primary diagnosis of MDD were treated with NeuroStar TMS Therapy and received an average of 28 TMS sessions during acute treatment.  Investigators evaluated improvement in pain measures using two quality of life instruments, the EuroQol Questionnaire (EQ-5D) and the Short Form 36-Item Questionnaire (SF-36).
    At baseline, 47.1 percent of patients indicated moderate pain and discomfort while 11.7 percent of patients indicated extreme pain and discomfort, which decreased significantly by the end of acute treatment to 41.4 percent and 6.6 percent of patients, respectively. The improvement in the percent of patients reporting extreme pain and discomfort was sustained through 12 months of follow-up, demonstrating durability in the most extreme pain cases.
    The percentage of patients reporting general pain-related problems significantly reduced from 58.8 percent at baseline to 48 percent at the end of acute treatment, as measured by the EQ-5D. In addition, the SF-36 bodily pain scores improved significantly following acute NeuroStar TMS Therapy from 44.5 to 48.1, which persisted through 12 months. There was a significant correlation between the improvement of the SF-36 bodily pain scores and the improvement of depressive symptomatology, as measured by the Patient Health Questionnaire (PHQ-9).
    About NeuroStar TMS Therapy®
    Neuronetics' NeuroStar TMS Therapy System was cleared by the FDA in October 2008 for the treatment of Major Depressive Disorder (MDD).  NeuroStar TMS Therapy is indicated for the treatment of MDD in adult patients who have failed to achieve satisfactory improvement from one prior antidepressant medication at or above the minimal effective dose and duration in the current episode. NeuroStar TMS Therapy is a non-systemic (does not circulate in the bloodstream throughout the body) and non-invasive (does not involve surgery) form of neuromodulation.  It stimulates nerve cells in an area of the brain that has been linked to depression by delivering highly-focused MRI-strength magnetic field pulses. The treatment is available by prescription and typically administered daily for 4-6 weeks.  For full safety and prescribing information, visit
    About Depression
    Depression is a serious illness that affects about 20 million Americans annually.  People with depression may experience a range of physically and emotionally debilitating symptoms, including anxiousness, sadness, irritability, fatigue, changes in sleep patterns, loss of interest in previously enjoyable activities and digestive problems.  It is estimated that about four million patients do not benefit from standard treatments for depression, even after repeated treatment attempts. 
    About the StudyThis study was designed to assess patient-reported pain outcomes following Transcranial Magnetic Stimulation (TMS) treatment for major depression disorder (MDD) in clinical practice. Three hundred and seven depressed patients were part of a prospective, multi-site, observational clinical trial studying the utilization and outcomes of the NeuroStar TMS Therapy system in naturalistic clinical practice. Patients who received benefit from acute TMS treatment (N= 257) consented to long-term follow up over 12 months, and were evaluable for statistical analysis. The objectives of the study were to assess the change in depressive symptomatology and functional capacities across the duration of the study. Data for the pain domains in the Short Form 36-Item Questionnaire (SF-36) and the EuroQol Questionnaire (EQ-5D) were collected at baseline, end of acute treatment (EOA), 3-, 6-, 9-, and 12-months follow-up, in order to evaluate the effect of NeuroStar TMS therapy on pain in patients with MDD.
    About Neuronetics, Inc.Neuronetics, Inc., is a privately-held medical device company focused on developing non-invasive therapies for psychiatric and neurological disorders using MRI-strength magnetic field pulses.  Based in Malvern, PA, Neuronetics is the leader in the development of TMS Therapy, a non-invasive form of neuromodulation.  For more information, please visit
    NeuroStar®, NeuroStar TMS Therapy® and TMS Therapy® are registered trademarks of
    Neuronetics, Inc.

    SOURCE Neuronetics, Inc.

    Research and Markets Announces The Release of 'Neuromodulation Market - Forecasts to 2017'

    PR Newswire  


    Research and Markets Announces The Release of 'Neuromodulation Market - Forecasts to 2017'

    DUBLIN, March 25, 2013 /PRNewswire/ --
    Research and Markets ( has announced the addition of the "Neuromodulation Market - [Spinal Cord Stimulation (SCS), Vagus Nerve Stimulation (VNS), Gastric Electrical Stimulation (GES), Deep Brain Stimulation (DBS), Sacral Nerve Stimulation (SNS), & Transcranial Magnetic Stimulation (TMS)] - Forecasts to 2017" report to their offering.
    Neuromodulation devices have emerged as one of the fastest growing segments of the medical device market due to high demand for minimally invasive and non-invasive treatment. With advancements in technology, neuromodulation is expected to become a promising therapeutic area and high growth industry in the next decade, as it offers symptomatic relief mainly from chronic pain, incontinence, heart failure, headache, depression, epilepsy, etc. The neuromodulation devices market includes deep brain stimulation, spinal cord stimulation, vagus nerve stimulation, sacral nerve stimulation and others external stimulation devices such as transcranial magnetic stimulation, and transcutaneous electrical nerve stimulation (TENS).
    The neuromodulation technique acts directly upon nerves or the target area where the activity of nerves is altered due to biological responses produced by electrical stimulation or drug infusion. These devices include small electrodes that are attached to the brain, the spinal cord, or peripheral nerves. These precisely placed leads are connected by means of an extension cable to a pulse generator to generate electrical stimulation. Neuromodulation can have applications in any area of the body and can treat several diseases like chronic pain, epilepsy, psychiatric disorder, movement disorder, cardiovascular disorder, genitourinary and colorectal disorder, stroke and brain injury, and gastric disorder.
    The main drivers for the neuromodulation market are the rising population of aged people and age-related diseases like Alzheimer's, epilepsy, spinal cord injury, and Parkinson's disease. According to the International Neuromodulation Society, about 40 million to 50 million patients worldwide suffer from epilepsy, and 1.5 million people currently (2012) suffer from Parkinson disease in the U.S. The large pool of patients that suffer from depression, stroke, anxiety disorders, lower back pain, urinary incontinence, and tremor offers the neuromodulation industry opportunities to grow in the next five years. The market for treatment of tinnitus, in particular, represents an emerging application of neuromodulation. According to the American Tinnitus Association, about 50 million people currently (2012) suffer from this disease in the U.S.
    Key Topics Covered:
    7 COMPANY PROFILES (Overview, Financials, Products & Services, Strategy, & Developments)*
    Companies Mentioned
    - Anm Adaptive Neuromodulation Gmbh
    - Biocontrol Medical, Ltd.
    - Boston Scientific Corporation
    - Cerbomed Gmbh
    - Cyberonics, Inc.
    - Endostim, Inc.
    - Enteromedics, Inc.
    - The Magstim Company Limited
    - Medtronic, Inc.
    - Neuronetics, Inc.
    - Neuropace, Inc.
    - Neurosigma, Inc.
    - Nevro Corporation
    - Rs Medical
    - Spinal Modulation, Inc.
    - St. Jude Medical
    - Synapse Biomedical, Inc.
    - Uroplasty, Inc.
    - Zynex, Inc.
    Research and Markets

    Laura Wood , Senior Manager
    U.S. Fax: +1-646-607-1907
    Fax (outside U.S.): +353-1-481-1716
    Sector: Medical Devices

    SOURCE Research and Markets

    Links referenced within this article

    Thursday, March 21, 2013

    Non-invasive vagus nerve stimulation for the treatment of acute asthma exacerbations--results from an initial case series.

    2013 Mar 19;6(1):7. [Epub ahead of print]

    Non-invasive vagus nerve stimulation for the treatment of acute asthma exacerbations--results from an initial case series.


    A prospective multicentre clinical study was initiated to evaluate the safety and potential clinical benefit of non-invasive vagus nerve stimulation (nVNS) for the treatment of bronchoconstriction exacerbations in asthmatics. Due to slow enrolment and design changes of the device, the study was prematurely terminated after enrolment of four eligible patients. Three of the four patients were considered treatment successes based on improvement in FEV1, improvement in VAS dyspnoea scoring, and the absence of device-related adverse events. Identifier NCT01385306.
    [PubMed - as supplied by publisher]

    Saturday, March 16, 2013

    Long-term outcome after callosotomy or vagus nerve stimulation in consecutive prospective cohorts of children with Lennox-Gastaut or Lennox-like syndrome and non-specific MRI findings.

    2013 Mar 9. pii: S1059-1311(13)00043-5. doi: 10.1016/j.seizure.2013.02.009. [Epub ahead of print]

    Long-term outcome after callosotomy or vagus nerve stimulation in consecutive prospective cohorts of children with Lennox-Gastaut or Lennox-like syndrome and non-specific MRI findings.


    Clinica de Epilepsia de Sao Paulo, Epilepsy Surgery Program, Sao Paulo, SP, Brazil. Electronic address:



    There is currently no resective (potentially curative) surgical option that is useful in patients with Lennox-Gastaut syndrome. Palliative procedures such as callosotomy (Cx), vagus nerve stimulation (VNS) or deep brain stimulation have been offered. We compared the outcomes after Cx or VNS in two consecutive prospective cohorts of patients with generalised epilepsy.


    Twenty-four patients underwent callosotomy from 2006 to 2007 (Group 1); 20 additional patients were submitted to VNS from 2008 to 2009 (Group 2). They had generalised epilepsy of the Lennox-Gastaut or Lennox-like type. They were submitted to a neurological interview and examination, interictal and ictal video-EEG, high resolution 1.5T MRI, and cognitive and quality of life evaluations. The two-year post-operative follow-up results were evaluated for each patient.


    The final mean stimuli intensity was 3.0mA in the Group 2 patients. Seizure-free patients accounted for 10% in Group 1 and none in Group 2. Ten and sixteen percent of the Group 1 and 2 patients, respectively, were non-responders. Improvements in attention and quality of life were noted in 85% of both Group 1 and 2 patients. Rupture of the secondary bilateral synchrony was noted in 85% of Group 1 patients; there was no EEG modification after VNS in Group 2. Both procedures were effective regarding the control of atypical absences and generalised tonic-clonic seizures. Both procedures were not effective in controlling tonic seizures. Callosotomy was very effective in reducing the frequency of atonic seizures, but VNS was ineffective. In contrast, callosotomy was not effective in reducing myoclonic seizures, whereas VNS was.


    Callosotomy might be preferred as the primary treatment in children with Lennox-Gastaut syndrome, and no specific findings on MRI if atonic seizures prevail in the patient's clinical picture; when myoclonic seizures prevail, the same might hold true in favour of VNS. When atypical absence or generalised tonic-clonic seizures are the main concern, although both procedures carry similar effectiveness, VNS might be considered a good option as an initial approach, taking into account the adverse event profile. Patients should be advised that both procedures are not very effective in the treatment of tonic seizures.
    Copyright © 2013. Published by Elsevier Ltd.
    [PubMed - as supplied by publisher]

    Friday, March 15, 2013

    Vagus nerve stimulation to augment recovery from severe traumatic brain injury impeding consciousness: a prospective pilot clinical trial.

    2013 Apr;35(3):263-76. doi: 10.1179/1743132813Y.0000000167.

    Vagus nerve stimulation to augment recovery from severe traumatic brain injury impeding consciousness: a prospective pilot clinical trial.


    New York University School of Medicine and NYU Langone Medical Center, New York, NY, USA.



    Traumatic brain injury (TBI) has high morbidity and mortality in both civilian and military populations. Blast and other mechanisms of TBI damage the brain by causing neurons to disconnect and atrophy. Such traumatic axonal injury can lead to persistent vegetative and minimally conscious states (VS and MCS), for which limited treatment options exist, including physical, occupational, speech, and cognitive therapies. More than 60 000 patients have received vagus nerve stimulation (VNS) for epilepsy and depression. In addition to decreased seizure frequency and severity, patients report enhanced mood, reduced daytime sleepiness independent of seizure control, increased slow wave sleep, and improved cognition, memory, and quality of life. Early stimulation of the vagus nerve accelerates the rate and extent of behavioral and cognitive recovery after fluid percussion brain injury in rats.


    We recently obtained Food and Drug Administration (FDA) approval for a pilot prospective randomized crossover trial to demonstrate objective improvement in clinical outcome by placement of a vagus nerve stimulator in patients who are recovering from severe TBI. Our hypothesis is that stimulation of the vagus nerve results in increased cerebral blood flow and metabolism in the forebrain, thalamus, and reticular formation, which promotes arousal and improved consciousness, thereby improving outcome after TBI resulting in MCS or VS.


    If this study demonstrates that VNS can safely and positively impact outcome, then a larger randomized prospective crossover trial will be proposed.
    [PubMed - in process]

    Association of cerebral metabolic activity changes with vagus nerve stimulation antidepressant response in treatment-resistant depression.

    2013 Feb 13. pii: S1935-861X(13)00033-8. doi: 10.1016/j.brs.2012.11.006. [Epub ahead of print]

    Association of cerebral metabolic activity changes with vagus nerve stimulation antidepressant response in treatment-resistant depression.


    Department of Psychiatry, Washington University, St. Louis, MO, USA; Department of Neurology and Psychiatry, Saint Louis University, St. Louis, MO, USA. Electronic address:



    Vagus nerve stimulation (VNS) has antidepressant effects in treatment resistant major depression (TRMD); these effects are poorly understood. This trial examines associations of subacute (3 months) and chronic (12 months) VNS with cerebral metabolism in TRMD.


    17Fluorodeoxyglucose positron emission tomography was used to examine associations between 12-month antidepressant VNS response and cerebral metabolic rate for glucose (CMRGlu) changes at 3 and 12 months.


    Thirteen TRMD patients received 12 months of VNS. Depression assessments (Hamilton Depression Rating Scale [HDRS]) and PET scans were obtained at baseline (pre-VNS) and 3/12 months. CMRGlu was assessed in eight a priori selected brain regions (bilateral anterior insular [AIC], orbitofrontal [OFC], dorsolateral prefrontal [DLPFC], and anterior cingulate cortices [ACC]). Regional CMRGlu changes over time were studied in VNS responders (decreased 12 month HDRS by ≥50%) and nonresponders.


    A significant trend (decreased 3 month CMRGlu) in the right DLPFC was observed over time in VNS responders (n = 9; P = 0.006). An exploratory whole brain analysis (Puncorrected = 0.005) demonstrated decreased 3 month right rostral cingulate and DLPFC CMRGlu, and increased 12 month left ventral tegmental CMRGlu in responders.


    VNS response may involve gradual (months in duration) brain adaptations. Early on, this process may involve decreased right-sided DLPFC/cingulate cortical activity; longer term effects (12 months) may lead to brainstem dopaminergic activation. Study limitations included: a) a small VNS nonresponders sample (N = 4), which limited conclusions about nonresponder CMRGlu changes; b) no control group; and, c) patients maintained their psychotropic medications.
    Copyright © 2013 Elsevier Inc. All rights reserved.
    [PubMed - as supplied by publisher]

    Thursday, March 14, 2013

    A patient-level meta-analysis of studies evaluating vagus nerve stimulation therapy for treatment-resistant depression.

    2013;6:17-35. Epub 2013 Mar 1.

    A patient-level meta-analysis of studies evaluating vagus nerve stimulation therapy for treatment-resistant depression.


    Berry Consultants, Austin, TX, USA.



    To compare response and remission rates in depressed patients with chronic treatment-resistant depression (TRD) treated with vagus nerve stimulation (VNS) Therapy® plus treatment as usual (VNS + TAU) or TAU alone in a meta-analysis using Bayesian hierarchical models.


    Six outpatient, multicenter, clinical trials that have evaluated VNS + TAU or TAU in TRD, including two single-arm studies of VNS + TAU (n = 60 and n = 74), a randomized study of VNS + TAU versus TAU (n = 235), a randomized study of VNS + TAU comparing different VNS stimulation intensities (n = 331), a nonrandomized registry of VNS + TAU versus TAU (n = 636), and a single-arm study of TAU (n = 124) to provide longer-term, control data for comparison with VNS-treated patients.


    A systematic review of individual patient-level data based on the intent-to-treat principle, including all patients who contributed more than one post-baseline visit. Response was based on the Montgomery-Åsberg Depression Rating Scale (MADRS) and the Clinical Global Impressions scale's Improvement subscale (CGI-I), as these were the two clinician-rated measures common across all or most studies. Remission was based on the MADRS.


    Outcomes were compared from baseline up to 96 weeks of treatment with VNS + TAU (n = 1035) versus TAU (n = 425). The MADRS response rate for VNS + TAU at 12, 24, 48, and 96 weeks were 12%, 18%, 28%, and 32% versus 4%, 7%, 12%, and 14% for TAU. The MADRS remission rate for VNS + TAU at 12, 24, 48, and 96 weeks were 3%, 5%, 10%, and 14% versus 1%, 1%, 2%, and 4%, for TAU. Adjunctive VNS Therapy was associated with a greater likelihood of response (odds ratio [OR] = 3.19, 95% confidence interval [CI]: 2.12, 4.66) and remission (OR = 4.99, CI: 2.93, 7.76), compared with TAU. For patients who had responded to VNS + TAU at 24 weeks, sustained response was more likely at 48 weeks (OR = 1.98, CI: 1.34, 3.01) and at 96 weeks (OR = 3.42, CI: 1.78, 7.31). Similar results were observed for CGI-I response.


    For patients with chronic TRD, VNS + TAU has greater response and remission rates that are more likely to persist than TAU.


    Bayesian meta-analysis, VNS Therapy, remission rate, response rate, treatment-resistant depression, vagus nerve stimulation
    [PubMed - as supplied by publisher]

    Tuesday, March 12, 2013

    The Brain Under Attack Again?

    The Brain Under Attack Again?
    Englewood Cliffs, NJ
    Wednesday, March 13, 2013

    Dr. Patricia A. Farrell
    Dr. Patricia A. Farrell
    Simplistic thinking may be attractive if you happen to be in one specific discipline, but I think that it rarely provides either the results that are sought or the research breakthroughs that are touted about in professional journals. Although the heyday of psychosurgery was probably sometime during the 50s and 60s, when it was alleged several extremely wealthy and prominent individuals had lobotomies, it seems to be having somewhat of a resurgence. Invasive procedures to the rescue!

    Lobotomies, as you may know, were crude attempts at surgical assaults on the frontal lobes of the brain to change behavior quickly and permanently. The man who was the maven of lobotomy was a Dr. Freeman who apparently frantically traveled around the country wielding a golden ice pick in a velvet case; this was his sole surgical instrument. Freeman was incredibly busy and, from what I have read, did not bother himself with extensive workups of patients, instead just going on from procedure to procedure to procedure. In my professional career I have only come across one patient in a hospital who had had a lobotomy to put an end to her rather violent and aggressive behavior. Did it do that? No, because she continued to threaten people and could not be placed in even the simplest job in the community. She spent the remainder of her life as a person with a severe seizure disorder in a supervised setting

    Surgery was seen as the answer to much of mental illness even from the time when Freud nearly destroyed a woman's nose in the belief that the nerve found there was causing her to be hypersexual in activity related to herself. Yes, I am being a bit delicate here. Other surgeons removed people's, or should I say women's, uteruses and pulled all of their teeth in the belief that both of these were causing mental illness

    It sounds quite barbaric, but it was a bit better than what they had been doing previously which was to lock people up in containers until they "came to their senses." Read some of the books by Dr. Thomas Szasz who did a great job on the history of psychiatric treatment

    I've seen some of this in one now-closed psychiatric hospital where people were put into "quiet rooms" until they calmed down. Some of these people had food withheld from them to facilitate this calming. Others, who became more worked up, tried to kill themselves by leaping from the small windowsill and aiming their heads at the ceramic floors. They did not succeed but did have quite serious injuries as a result. The practice went on

    Patients with psychiatric disorders were chained to the walls, pounded with something that looks like a fire department hose (I believe these are similar to the Scotch shower used in some spas) or were placed in tubs filled with ice water that would then be tightly covered on top with a canvas so that only their heads poked out. Think "Snake Pit" here. There's quite an interesting correlation here between this treatment and why people die in the snow in the woods when they get lost. The freezing cold causes them to become sleepy and tired and they sit or lie down and die. So, placing patients in a freezing tub of ice cube-filled water may have a calming effect for a brief period of time, but it certainly is a punishment more than a treatment

    Several psychiatric disorders currently classified in the manual known as the DSM (Diagnostic and Statistical Manual) are particularly resistant to a number of therapies. When I use the word resistent what I mean is that the treatments are really not effective or insufficiently effective because simplistic reasoning seems to be in use here. One pill or three pills together probably do not address the disorder because it is much more complex than anyone knows right now

    Just as we know that cancer may have a number of not only different forms, but be caused by a number of different viruses including who knows how many numbers of genes all acting in concert, it doesn't work. Patients who suffer greatly from these disorders will try desperately for any relief and anyone who offers a glimmer of hope will be to whom they will go. It's the same as it is with the cancer patients

    Now we are hearing about a number of intrusive measures aimed at alleviating the symptoms of these disorders by either putting electrodes into the brain (of people with anorexia) or something like a pacemaker. It would seem that electricity is regaining a prominent role in this area. We know that ECT (electroconvulsive shock therapy) is being used on an outpatient basis and, for some, it seems to work. But it is not a cure all. The body and in particular the brain is still highly mysterious and it will not give up its secrets easily

    A few years ago there was a belief, and it may still be active in the medical community, that the vagal nerve that runs down the center of the body in the area of the abdomen, was actively involved in producing treatment resistant depression. If, somehow, this nerve would be brought under control, then perhaps depression could be lifted in patients who were receiving no benefits from antidepressant medications. The FDA approved the device in 1997 for epilepsy and then researchers tried it for depression

    A specially designed nerve stimulator was placed in the abdomen of patients and it was believed that this was a breakthrough in depression treatment. Still used in some of the most famous psychiatric clinics in the United States, the VNS (Vagal Nerve Stimulator) has had somewhat mixed results on at least one (and possibly more) trial where some patients had their stimulators turned on and others didn't. Reports indicate that half of the patients, whether or not they had their stimulator turned on, improved. Sounds like the placebo effect to me

    The technology, which I understand would be extremely difficult to remove, is going to be tried on patients with anxiety, Alzheimer's, tinnitus, migraines and fibromyalgia. It's almost as though they are hoping it will work well for something if not more than one thing. I remain a bit skeptical

    Technology can be a lifesaver and there is no doubt about that. But my concern is that, without a true understanding of the sum total of the underlying mechanics, and I use that word advisedly, of a disorder, it's as though they are persons walking in the dark and hoping to find the light switch

    Psychiatric disorders are dreadful and cause people enormous pain and it is this pain which will lead them to try almost anything. Again, comparing it to cancer, I remember the case of the famous actor Steve McQueen who, after he developed cancer, went to Mexico for an experimental treatment with Laetrile. Reports of his condition revealed that he, as many others, had been duped and he died in Mexico refusing to allow anyone to see him in his debilitated state.

    Desperation is the parent that provides hope where no hope exists. Once again, I remind people of that famous phrase we use whenever you are going to go shopping for something; caveat emptor, let the buyer beware. It doesn't matter if someone or someplace tells you that they have had remarkable success and that their success rate is two or three times that of others. We've seen too many times that people cherry pick their statistics for their patients so that they can use these types of promotional techniques to get new patients. Unfortunately, medicine is a business and, like any business, it needs to always look at the bottom line.

    Dr. Patricia A. Farrell, Ph.D.
    Licensed Psychologist
    Dr. Patricia A. Farrell, Ph.D., LLC
    Englewood Cliffs, NJ