Post Traumatic Stress Disorder Clinical Trial
Official title:
A Pilot Study of Low Field Magnetic Stimulation in PTSD: Three Daily Treatments
The investigators propose to make the first observations of LFMS treating a population of subjects with PTSD. A positive outcome for this study could translate directly into a new treatment modality for symptoms of PTSD in both acute and chronic situations. The investigator's goal is to demonstrate the safety and efficacy of LFMS as a possible aid in the treatment of PTSD.
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. LFMS
electromagnetic fields are significantly weaker than those occurring in electroconvulsive
therapy (ECT) and repeated transcranial magnetic stimulation (rTMS).
LFMS was discovered at McLean Hospital and has been studied as an experimental
antidepressant treatment at McLean. Results from the investigator's single-visit protocol
(2006-P-001655) are encouraging, and demonstrate an immediate mood improvement from LFMS in
depressed subjects. This indicates that LFMS continues to show potential as a treatment for
depression. The profile of clinical response to LFMS that was observed in that study
included improvement in symptoms of anxiety. In this current proposal the investigator's
will study the effects of LFMS on these symptoms of depression and anxiety that are present
in a population with a primary diagnosis of PTSD. The proposed protocol involves three
treatments on consecutive days with follow-up ratings one week after the first treatment and
follow-up by phone ratings in weeks three and four after the first treatment.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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