Finding studies
Finding studies
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Lead
VA Office of Research and Development
Mild traumatic brain injury (mTBI), post-traumatic stress disorder (PTSD) and alcohol use disorder (AUD) are high priority disorders for the Department of Veterans Affairs (VA), in part, because these disorders rarely occur in isolation. The co-occurrence compounds brain impairment and negatively impacts symptom presentation and rehabilitation effectiveness. Veterans with co-occurring AUD, mTBI and/or PTSD have few effective treatment options. Thus, treatment development for these Veterans is of great need. The aim of this protocol is to examine safety, feasibility, and the behavioral and neural effects of an repetitive transcranial magnetic stimulation (rTMS) intervention for Veterans with AUD and co-occurring mTBI and/or PTSD. Behavioral and neural effects of rTMS will be examined after the first rTMS session and after the last rTMS session. The investigators hypothesize that the rTMS intervention will be 1) safe, 2) feasible and 3) efficacious. Specifically, the investigators hypothesize that there will be no adverse events related to the rTMS intervention. The investigators hypothesize that all participants enrolled will successfully complete all rTMS sessions. The investigators hypothesize that participants treated with active rTMS, relative to placebo rTMS, will have reduced alcohol craving severity levels. Finally, the investigators hypothesize that participants treated with active rTMS relative to placebo rTMS will have reduced brain activation in response to alcohol cues and improved functional connectivity after the last rTMS session. This is a prospective, pilot, double-blind randomized controlled trial of the intervention rTMS. There will be 2 groups of Veterans with AUD and co-occurring mTBI and/or PTSD those given 1) active rTMS and those given 2) placebo rTMS. Targeted enrollment for this study is 20 Veterans: n=10 active rTMS and n=10 placebo rTMS. Participants will be screened for safety and evaluated on mental health-related behavioral measures. Eligible participants will be randomized to receive active or placebo rTMS. Participants will then complete motor thresholding (MT) to determine rTMS intensity. Participants will then complete 10 sessions of rTMS. These sessions will be completed once daily on week days over two weeks. TMS pulses will be applied to the left DLPFC at 10Hz rate, 4.9 seconds per train, with inter-train interval of 30 seconds, and a total of 20 trains per session. After the 10th rTMS session, participants will complete an MRI which will last approximately 1hour. A sub-sample of participants will complete an MRI immediately after the first rTMS session. Participants will also repeat the mental health behavioral measures after the last rTMS session. Participants will complete follow-up phone interviews to assess for alcohol craving, mTBI symptoms and PTSD symptoms at one day, one week and one month post-rTMS. Completion of this study is an essential first step towards treatment development for Veterans with co-occurring AUD, mTBI and/or PTSD.
Age
22–65
Sex
ALL
Healthy volunteers
Not accepted
