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Washington - FDA Clears Brain Device To Treat Obsessive-Compulsive Disorder

Published on: February 20, 2009 09:52 AM
By: AP
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Patients suffering from obsessive, distressing thoughts have a new treatment option: a pacemaker-like device that relieves anxiety with electrical jolts to the brain.

The Food and Drug Administration on Thursday approved Medtronic’s Reclaim Deep Brain Stimulator device as the first implant to treat obsessive-compulsive disorder, which causes uncontrollable worries, such as fear of germs or dirt.

Patients suffering from the disorder try to relieve their anxiety with obsessive behavior, such as washing their hands or checking locks repeatedly.

“These are obtrusive thoughts that take control of people’s lives to the point that they lose their jobs, can’t have relationships and in many cases, can’t even leave their homes,” said Dr. Hooman Azmi of Hackensack University Medical Center.

While about 2.2 million Americans have the disorder, the new device would only be available to a small group of patients who don’t respond to other treatments, such as antidepressant drugs and therapy.

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The FDA approved the device under a program reserved for conditions that effect fewer than 4,000 people each year.

The FDA’s director for devices stressed that Reclaim provides some relief, but patients likely will have to continue taking medications as well.

“Reclaim is not a cure,” Dr. Daniel Schultz said in a statement. “Individual results will vary and patients implanted with the device are likely to continue to have some mild to moderate impairment.”

Shaped like a pacemaker, the Reclaim device is implanted under the skin of the chest and then connected to four electrodes in the brain. The electrodes deliver steady pulses of electricity that block abnormal brain signals.

Similar devices have been used since the 1990s to treat movement disorders like Parkinson’s disease and tremors. But where prior devices target areas of the brain that deal with movement, Medtronic said its product delivers electrical signals to areas that control mood and anxiety.

“What deep brain stimulation does is modulate those circuits that we believe are hyperactive in patients with obsessive compulsive disorder,” said Paul Stypulkowski, the company’s senior director of research.

Medtronic Inc., the world’s largest medical device maker, also is studying the use of the technology in patients with severe depression.

In 2005, rival Cyberonics became the first company to win FDA approval for a device to treat depression. However, the company’s Vagus Nerve Stimulator has been plagued by questions of effectiveness.

Members of Congress and consumer watchdog groups campaigned against the Cyberonics device, citing research that some patients who have received it had worsening depression. A number of insurers, including the government’s Medicare program, have refused to pay for the device in depression patients.

Medtronic representatives point out that their technology differs from that used by Houston-based Cyberonics, which delivers an electrical signal to nerves in the neck. Medtronic’s devices stimulate the brain directly.


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1

 Feb 20, 2009 at 09:14 AM Big Masmid Says:

I guess my friend will not be washing his hands 100 times a day

2

 Feb 20, 2009 at 09:27 AM Psychologist Says:

"Patients suffering from the disorder try to relieve their anxiety with obsessive behavior, such as washing their hands or checking locks repeatedly. "
I think they mean "...relieve obsessive anxiety with 'compulsive' behavior" The anxiety represents the ossessiveness and the behavior is compulsive, a repeating (failed) attempt to dispell the anxiety with a behavior.
This treatment sounds frightening, but may be necessary for some. There exists a relatively large precentage of clients with OCD who are "treatment refractory." That is, they are not significantly helped by therapy and medication, even with the addition of an anti psychotic (which does help some). For these cases, there is evidence to suggest significant brain abnormalities and lesions. These individuals suffer terrible and thier lives are consumed by their symptoms. Thus, the need for this invasive treatment.

3

 Feb 20, 2009 at 10:21 AM OCD Says:

I have OCD, and Prozac helps me a lot with my obsessive thoughts. Refuah shleimah to all who struggle with this wretched disorder. Don't be afraid to get help.

4

 Feb 20, 2009 at 10:45 AM ocdsux Says:

Reply to #1  
Big Masmid Says:

I guess my friend will not be washing his hands 100 times a day

lol true but not funny - sad

5

 Feb 20, 2009 at 11:51 AM A former sufferer Says:

Reply to #3  
OCD Says:

I have OCD, and Prozac helps me a lot with my obsessive thoughts. Refuah shleimah to all who struggle with this wretched disorder. Don't be afraid to get help.

I would advise you to go to a frum psychologist who can talk you out of having those “circular reasoning” thoughts. I did, and oh am I glad that I did. I don’t know how drugs work to stop it, and I’m afraid that this new shock treatment of the brain is very dangerous; who know what else it will stop? IMO the best treatment is to get rid of the root causes, to get rid of what causes this way of thinking, or at least to know how to put a stop to such thinking. If the obsession is “frum based” which causes tremendous suffering then ONLY a frum psychologist who can relate to your way of thinking can really help you get rid of this meichish. I wish you a total refuah.

6

 Feb 20, 2009 at 11:52 AM A former sufferer Says:

Reply to #1  
Big Masmid Says:

I guess my friend will not be washing his hands 100 times a day

If you are his friend, then tell him a hundred times a day to go get help.

7

 Feb 20, 2009 at 12:07 PM Melvin Says:

every brain gets electric signals (it’s not 110 watts or close to it) so don’t be afraid to get the help available. it’s not more dangers then medication that balances the chemical level in your brain.

8

 Feb 20, 2009 at 01:00 PM A former sufferer Says:

Reply to #7  
Melvin Says:

every brain gets electric signals (it’s not 110 watts or close to it) so don’t be afraid to get the help available. it’s not more dangers then medication that balances the chemical level in your brain.

Chemicals work with the body, they know each other. Shock to the brain sounds to me more like a hammer and a screw driver applied to the brain. I really don’t know so maybe I shouldn’t talk.

9

 Feb 20, 2009 at 01:45 PM JGS Says:

I had OCD a few months a go and went to therapy.Right now i'm back up to speed.If u need help get it.It is sooooo worth it!! please !!!!don't just take it from me.It can kill you it was the most painful experience of my life but with help i moved on .It may be hard at first but if you need help get it it really works.I promise.

10

 Feb 20, 2009 at 02:54 PM Anonymous Says:

Sounds amazing. May be as successful as cochlear implants where the electrodes stimulates the cranial auditory nerve and it works wonders.

11

 Feb 22, 2009 at 12:19 AM Anonymous Says:

Can anyone recomend a frum therapist in Brooklyn who specializes with ocd in children?

12

 Feb 22, 2009 at 08:13 AM DBS fan Says:

For those of you who are afraid of "shock" to the brain. It is a miniscule amount of energy. Your heart and brain produce electricity. There are millions of people with pace makers implanted to send electricity to the heart. The Deep Brain Stimulater is a similar concept. It is already being used for Parkinsons patients and patients with other movement disorders.

There where some posative studies on DBS use for patients with Traumatic Brain Injuries.

13

 Feb 22, 2009 at 05:23 PM Recovered From Severe OCD Says:

I had a very severe case of OCD. You can't imagine how bad. No medcation helped me. ONLY Behvavior Therapy. was the cure.

I went to the Institute of Behavior Therapy in Manhattan on E. 40th St. - (212) 692-9288. Bob Liroff was my therapist. They take Medicare - still have to pay something. He makes housecalls if necessary. That can be expensive. He was my good Shaliach, Boruch Hashem.

Thinking one day of making a free support group in Boro Park. It might not be for many, many years. Like others - I don't want to be known, since most of the world didn't know I had this problem and I don't want to have this stigma. I was stuck mostly all the time in the house because of the OCD.

I have been to hospitals - no where helped. They gave me all kinds of medications. I can write a book.

Anyhow - contact Bob Liroff - he is not frum - but learned about yiddishkeit from other patients as well.



Hatzlacha to all.

14

 Feb 23, 2009 at 12:35 AM Anonymous Says:

I've got to get this device.

15

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