The purpose of the proposed study is to evaluate initial feasibility and efficacy of Theta Burst Transcranial Magnetic Stimulation (TBS) as an adjunct treatment for Veterans with PTSD. Primary outcomes measures include a feasibility of TBS procedures, with secondary outcome measures focusing on changes in PTSD symptom severity and quality of life and social/occupation functioning.
The purpose of the proposed study is to evaluate the feasibility of theta burst transcranial magnetic stimulation (TBS) as an adjunct treatment for Veterans with PTSD. This project will result in development of methods needed to conduct an adequately powered, randomized controlled study of TBS for PTSD, which will assess the relationship between change in symptoms and quality of life. It will also lay the foundation for subsequent rehabilitation studies combining neuromodulation and psychotherapy in the longer term. TBS has several advantages compared to standard repetitive Transcranial Magnetic Stimulation (rTMS), including its ability to deliver large numbers of stimulation pulses in a shorter time period, and a stimulation pattern that may specifically affect key brain regions involved in PTSD. The significance of this research is the development of a novel, non-invasive brain stimulation approach for PTSD recovery. This project will provide the foundation for the development of methods needed to conduct an adequately powered, randomized controlled study of TBS for PTSD to ultimately develop brain stimulation techniques that can be combined with evidence-based psychotherapy, to develop a more powerful, individualized rehabilitation option for Veterans with PTSD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
56
Theta burst transcranial magnetic stimulation
Sham Theta burst transcranial magnetic stimulation
Providence VA Medical Center, Providence, RI
Providence, Rhode Island, United States
Number of Participants Retained, a Measure of Acceptability of TBS Procedures
Measurement of TBS acceptability, measured using participant retention rates (all-cause discontinuation)
Time frame: 2 weeks
Change in Quality of Life Due to TBS Treatment
Change in the quality of life, using the quality of life questionnaire QLESQ - Quality of Life Enjoyment and Satisfaction Questionnaire (General Quality of Life Index). A self-report scale covering multiple domains (physical health, subjective feelings, leisure time activities, social relationships, treatment satisfaction) The General Quality of Life Index took the mean of all domains. Scores range from 0-5, with higher scores indicating higher quality of life.
Time frame: Baseline and end of double-blind period (2 weeks)
Change in PTSD Symptom Severity
Change in PTSD symptoms measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5). The CAPS-5 is a structured interview to measure for PTSD symptom change and presence/absence of PTSD, items rated 0 = 'absent' to 4 = 'extreme/incapacitating,' total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms. Higher scores indicate more severe PTSD symptoms.
Time frame: Baseline and end of double-blind period (2 weeks)
Change in Social/Occupational Functioning (QOL/SOF) Due to TBS Treatment
Change measured using the social/occupational functioning assessment scale (SOFAS). Clinician rating of social \& occupational functioning. Scale of 0-100 with higher scores indicating higher functioning.
Time frame: Baseline and end of double-blind period (2 weeks)
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