Interesting article in a right-wing Israeli online newsletter

[Guest guest]

How about stroke? A lot less uncomfortable than scalp needling therapy.

-- Jerry Cohen

 

http://www.israelnationalnews.com/News/News.aspx/128096

Published: 10/27/08, 2:54 PM

Israeli Firm Tests New Deep-Brain Treatment for Depression

 

by Hana Levi Julian

 

(IsraelNN.com) An Israeli medical firm has just completed a 70-patient

clinical trial at Shalvata Mental Health Center in Hod HaSharon testing

a deep-brain stimulation device which it hopes to use as a new treatment

for neuropsychiatric brain disorders.

 

Brainsway Ltd. CEO Uzi Sofer told Israel National News on Monday that

the company has just won the go-ahead from the U.S. Federal Drug

Administration (FDA) for a multi-center clinical trial of the " Deep TMS "

device, which it hopes will lead to the FDA's final stamp of approval.

 

That study, expected to begin in January 2009, will be conducted at

Shalvata Hospital, as well as in Hadassah Ein Kerem Medical Center and

Givat Shaul Mental Center (both in Jerusalem), Be'er Yaakov Medical

Center, Rambam Medical Center in Haifa, and Soroka Medical Center in

Be'er Sheva.

 

In the United States, clinical trials will be conducted at numerous

sites, including Johns Hopkins University Medical Center, UCLA, Davis

Hospital, Howard University and Columbia University in New York City.

 

Patients who are accepted for treatment receive a series of twenty

20-minute sessions, five days a week, for four weeks. According to the

current available data, the effectiveness of the treatment has lasted as

long as 24 weeks, with no negative effects, said Sofer.

 

" We have a high percentage of responders, " said Sofer, " and a high

percentage of patients who go into remission (from depression). "

 

How It Works

 

Deep TMS (transcranial magnetic stimulation) is a non-invasive technique

used to apply brief magnetic pulses to the brain, which are administered

by passing high currents through an electromagnetic coil placed on the

patient's scalp. The pulses induce an electric field in the underlying

brain tissue, activating specific neurons.

 

The device is being used to target the limbic system, which is related

to mood regulation, in an attempt to treat depression that has proved

unresponsive to other forms of treatment.

 

Direct electromagnetic activation is limited to 1.5 cm of the cortical

brain regions; however, the deeper limbic system structures are

nonetheless affected through secondary processes that involve the

cortical structures.

 

'Clean Bill of Health' in Safety Trials

 

A statement on the company's website informs the reader that the

treatment is " non-invasive, with no significant side effects, no

systemic effect (in contrast to drugs), and no need of hospitalization

or anesthesia. " The statement was substantiated in actual trials, said

Sofer, both in Israel and in the U.S.

 

" We have been testing the system since 2003, actually, " he said, " when

we first began safety trials at the National Institutes of Health (NIH)

in Washington DC. In November 2004 we conducted a safety study in Israel

as well. There has been no negative feedback, and we have tested the

device on hundreds of patients. "

 

The system, invented by a neurologist and a general medical doctor who

were two of the company's five founders – " the company has since

gone public, " Sofer notes – is also being tested in clinical trials

as a treatment for Bipolar Disorder and Schizophrenia.

 

In addition, he said, clinical studies are in process to test the system

as a possible treatment for conditions as diverse as autism, addictions,

Parkinson's disease, Alzheimer's disease, obesity and Post-Traumatic

Stress Disorder (PTSD).

 

Although no one can guarantee anything, Sosa said that treatment of

depression with the Deep TMS system looks very hopeful. " We think that

we have found, for drug-resistant people, a really good treatment for

depression and there are no side effects, " he said. " If someone is here

in Israel he can start immediately in one of our trials and it won't

cost anything. "

 

For further information about clinical trials, contact Brainsway.