Bipolar Depression Clinical Trial
Official title:
Low Field Magnetic Stimulation in Mood Disorders in Six Visits
To demonstrate the efficacy of multiple applications of Low Field Magnetic Stimulation (LFMS) as an antidepressant treatment in subjects with mood disorders.
The Low Field Magnetic Stimulation (LFMS) procedure is an application of a series of
electromagnetic pulses to the brain lasting twenty minutes. The field and timing parameters
of the LFMS pulses, such as pulse timing, duration, frequency, and electric and magnetic
field distribution and direction are different from other neurostimulation methods.
The mechanism of action for the antidepressant effects of LFMS is hypothesized to be an
effect on dendritic or synaptic activity in the cortex, brought about by low level
electrical stimulation applied with particular timing. This is analogous to the synaptic
effects of pharmaceutical antidepressants in providing a "boost" to synapses in certain
brain regions.
Previous investigations of LFMS included depressed subjects with bipolar disorder. This
study will evaluate the antidepressant effects of multiple LFMS treatments in bipolar
disorder and major depressive disorder.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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