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January 26, 2007
 FDA Executive Summary of NeuroStar TMS System
The NeuroStar TMS System was presented to the U.S. Food and Drug
Administration (FDA) Neurological Devices advisory panel as a
treatment for major depressive disorder.
The NeuroStar device employs repetitive transcranial magnetic
stimulation (TMS) to stimulate neurons in the brain that are linked
to depression. The therapy is performed in an outpatient setting and
is non-invasive.
The test results of a six-week, double-blind, placebo
(sham)-controlled, monotherapy clinical trial indicated that the
NeuroStar System therapy was well-tolerated by the 325 trial
participants. The discontinuation rate due to side effects was less
than five percent. Those who received the active therapy achieved
remission at twice the rate of those receiving the sham therapy.
However, the difference between the depression relief of the sham
treatment and real treatment were not statistically significant and
both treatments alleviated symptoms for participants. The following
endpoint scores were included: MADRS; HAMD24; HAMD17; SF-36 Mental
Health Score; HAMD Anxiety/Somatization, Core Depression, Gibbons,
Retardation, and Sleep scores; IDS-SR; CGI-S; and PGI-I.
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