This is a multicenter (4 clinical sites, Coordinating Center, Data Coordinating Center, Electrophysiology Resource Center, and Data and Safety Monitoring Board) double blind, sham-controlled, parallel group, randomized clinical trial, with adaptive features.
Posttraumatic stress disorder (PTSD) is a disabling and prevalent psychiatric disorder with limited effective treatment options. In addition to the clinical features of the disease, pathologic changes in the electroencephalogram (EEG), including decreased alpha power, have been reported.
Neuromodulation has been investigated as a therapeutic modality for neuropsychiatric disorders, such as PTSD. Recent human clinical studies of transcranial magnetic stimulation (TMS) suggest some improvement in clinical symptomatology and EEG phenotype in PTSD patients with a short course of treatment. We hypothesize clinical improvement in patients with PTSD coinciding with changes in EEG measures.
We conducted a prospective, sham-controlled, multisite pilot study of sTMS delivered to patients who were symptomatic despite ongoing pharmacotherapy for PTSD and MDD, hypothesizing sTMS would be feasible, safe and effective at reducing these symptoms.
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