Posttraumatic Stress Disorder Clinical Trial
Official title:
Multimodal Image Analysis and Guidance of Neuromodulation for Trauma-Related Symptoms
MAGNETS is a prospective, randomized, parallel-design, sham-controlled clinical trial of accelerated, functional magnetic resonance imaging (fMRI)-guided intermittent theta burst stimulation (iTBS) to the right dorsolateral prefrontal cortex (dlPFC) for chronic symptoms of posttraumatic stress disorder (PTSD) in a comorbid Veteran population.
In MAGNETS, sixty-four participants will be recruited from the NMVAHCS PTSD programs, Polytrauma services, and outpatient mental health clinics. At study entry (Visit #1), participants will undergo baseline demographic, behavioral, and cognitive assessment, and fMRI and diffusion tensor imaging (DTI). The data analysis team will then determine the image-based target in the right hemisphere. Participants will be randomized to either the active (n=32) or sham (n=32) group and undergo 50 sessions of iTBS (10x/day, five days). At end of treatment (Visit #2), they will repeat all baseline tests, including fMRI. One-, three- and six-month symptom levels will be obtained through phone visits (Visits #3-5) to establish longevity and stability of benefit. Repeated measures analyses will be performed on behavioral and connectivity variables, with clinical (age, duration, head injury history) and imaging (white matter fiber counts) features as covariates. ;
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