Deep brain stimulation: Experts raise alarms about aggressive marketing

An article in the Harvard Health Blog discussing the Health Affairs paper and its write up in the New York Times. Read it here.

Wariness on Surgery of the Mind

A very balanced and thoughtful article written by Benedict Carey in the NYTimes on a paper which appeared in the February issue of Health Affairs. This paper makes some ethical arguments regarding the use of the Humanitarian Device Exemption for DBS in Obsessive-Compulsive Disorder.

Deep Brain Stimulation Studied for Depression

Jun Yan writes in Psychiatric News about Dr. Helen Maybergs lecture at the APA in May 2008 in which she presented the data of her cg25 DBS depression study.

Psychiatric News June 20, 2008

Volume 43, Number 12, page 20
© 2008 American Psychiatric Association

Medtronic: Tapping the Brain for Profit

Very interesting article in US News & World Report on how neuromodulation is going to be crucial for the economic development of device manufacturers.

'moving from heart to head'.....

Mending a broken mind

Another press article by Globe and Mail (Canada) on the Lozano/Mayberg study.

A cure for depression?

A nice write-up on the DBS depression study published recently in Biological Psychiatry by Andres Lozanno, Helen Mayberg et al. Find the article here and the link to the original article here.

Magnetic Pulses Zap Migraine Pain

BOSTON, June 27 -- For patients who get migraine with aura, a hand-held magnetic device about the size and shape of a hairdryer can zap the pain before it starts, a researcher said here.

Used at the aura stage, the transcranial magnetic stimulation device was nearly twice as likely as a sham treatment to reduce the incidence of a full migraine headache, according to Yousef Mohammad, M.D., of Ohio State University Medical Center in Columbus.

The industry-sponsored phase III randomized double-blind trial follows earlier research that showed the magnetic stimulation process was effective when used in a hospital setting, Dr. Mohammad told attendees at the American Headache Society meeting.

Dr. Mohammad said the device -- which sends two one-Tesla magnetic pulses into the back of the head -- is also safe, with no serious adverse events attributed to it.

"It feels like a slight pressure at the back of the head and that's it," he said.

The theory is that the magnetic pulses interrupt a process called cortical spreading depression, now thought to be the underlying mechanism for migraine with aura, he said.

A similar technique is being tested in patients with depression.

For this study, patients were randomized to a device that emitted the magnetic pulses or to a sham machine. They were told to use the device when the migraine aura began and to record their pain intensity and symptoms at time of treatment and again 30 minutes, one hour, two hours, 24 hours, and 48 hours later.

The intent-to-treat population of 164 patients had a mean age of 39 and 79% were women. Most patients treated themselves while still pain-free or with mild pain (31% and 40%, respectively) but 23% had moderate pain and 6% said their pain was already severe before they used the machine.

The primary endpoint of the study was absence of pain at the two-hour mark, Dr. Mohammad said, where 39% of the active treatment group had no pain, compared with 20% of those using the sham machine.

The difference was significant at P<0.018, he said.

Rates of symptoms such as nausea, photophobia, and phonophobia in the active treatment group were equal to or lower than those seen in the group using the sham machine, according to Dr. Mohammad.

Because of the lack of adverse events and the previously established safety of the transcranial magnetic stimulation device, he said, "this is a promising treatment for migraines with aura."

He added that it also sets the stage for research in migraines without aura.

The device is not yet approved by the FDA, Dr. Mohammad said, but the okay could come within the next six months, based on the current trial.

He added that medical treatments for migraine with aura work in only about half of all patients and some of those can't tolerate the drugs. "There is a definite need for alternatives," Dr. Mohammad said.

The study was supported by NeuraLieve Inc., of Sunnyvale, Ca., manufacturer of the device. Dr. Mohammad serves on the company's medical advisory board

Primary source: AHS Meeting

Secondary Source: medpageTODAY®
Source reference:
Lipton RB, et al “Transcranial Magnetic Stimulation (TMS) using a portable device is effective for the acute treatment of migraine with aura: Results of a double-blind, sham controlled, randomized study” AHS Meeting 2008; LB abstract 450026.

St. Jude gets depression study under way

CHICAGO, June 26 (Reuters) - St. Jude Medical Inc (STJ.N: Quote, Profile, Research) said on Thursday that the first two patients had received its pacemaker-like implant as part of a clinical study to determine whether deep-brain stimulation will help people with severe depression.

A 59-year-old woman and a 42-year-old man were implanted with the St. Jude Medical Libra Deep Brain Stimulation System, an investigational device, at Alexian Brothers Behavioral Health Hospital in Chicago, the company said.

The stopwatch-sized device is implanted in the chest, with leads that send electrical impulses to specific parts of the brain thought to be involved in depression.

St. Jude's study is researching a specific area in the brain called Brodmann Area 25 that is thought to play a role in depression. Brain imaging studies indicate that Brodmann Area 25 appears to be overactive in severely depressed people.

Medtronic Inc (MDT.N: Quote, Profile, Research) is also investigating whether its device, commonly known as a "brain pacemaker," can help severely depressed patients.

The National Institute of Mental Health estimates that more than 21 million U.S. adults suffer from some kind of depressive disorder. Current therapies are effective for about 80 percent of this patient population, according to the National Advisory Mental Health Council, leaving about 4 million adults who do not respond to medication, psychotherapy or electroconvulsive therapy.

Shares of St. Jude, which also makes cardiac pacemakers and implantable cardioverter defibrillators, were down 83 cents, or 2 percent, at $40.42 at midday amid a weaker broad market. (Reporting by Debra Sherman; Editing by Maureen Bavdek)