Transcranial Magnetic Stimulation to Improve Functioning in Veterans With PTSD
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
Summary
- Conditions
- PTSD
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Participants are assigned to one of two or more groups in parallel for the duration of the study: procedure vs. sham procedureMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 19 years and 70 years
- Gender
- Both males and females
Description
Background Posttraumatic Stress Disorder (PTSD) is an often chronic and disabling condition prevalent in the Veteran population. While there is sufficient evidence to demonstrate the effectiveness of medications and psychotherapy for improving PTSD symptoms, there has been limited study of functioni...
Background Posttraumatic Stress Disorder (PTSD) is an often chronic and disabling condition prevalent in the Veteran population. While there is sufficient evidence to demonstrate the effectiveness of medications and psychotherapy for improving PTSD symptoms, there has been limited study of functioning as an outcome, and the role of other treatments such as somatic therapies. One promising but understudied somatic treatment for PTSD is repetitive transcranial magnetic stimulation (TMS). The characteristics of TMS treatment are different than those of existing treatments and may provide alternative treatment to Veterans who do not respond to medications and psychotherapy. Further, it is possible that TMS may have a greater effect on functioning and lead to higher rates of recovery compared with medications or psychotherapy. Objective To determine whether Veteran participants with PTSD who receive TMS delivered to the right dorsolateral prefrontal cortex at 1 Hz have greater improvements in: PTSD symptoms, functioning, and depressive symptoms than Veterans receiving sham treatments at treatment completion and at 3 and 6 months after treatment completion. Method 91 Veterans with PTSD will be randomly assigned to receive low frequency TMS or sham TMS. All TMS will be applied to the right dorsolateral prefrontal cortex. PTSD symptoms, functional outcomes, and depressive symptoms will be measured for all participants at treatment completion, 3 months, and 6 months after completion. Hypothesis Veterans with PTSD receiving TMS will have greater improvements in PTSD symptoms, functioning, and depressive symptoms at treatment completion and at three and six months after treatment completion compared to Veterans receiving sham TMS.
Tracking Information
- NCT #
- NCT04207346
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Bradley V Watts, MD MPH White River Junction VA Medical Center, White River Junction, VT
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