Pilot rTMS for AUD+mTBI (NCT03995173) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Pilot rTMS for AUD+mTBI
United States1 participantsStarted 2019-03-21
Plain-language summary
This is a pilot randomized controlled trial (RCT) for Veteran participants with alcohol use disorder co-occurring with mild traumatic brain injury and/or post-traumatic stress disorder. The treatment intervention is repetitive Transcranial Magnetic Stimulation (rTMS) and the goal is to reduce alcohol craving with this treatment. The study will enroll 20 Veteran participants. Half of these participants will receive real rTMS and half of the participants will receive placebo rTMS. rTMS treatment will be provided over 10 sessions that will occur once every weekday for 2 weeks. Veteran participants will then complete follow-up phone calls to further evaluate alcohol craving and other symptoms.
Who can participate
Age range
22 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* English Speaking
* Veterans
* Ages 22 through 65
* Meeting AUDIT-C criteria for AUD (4 for men and 3 for women)
* Pass MRI screening using the Center for Translational Imaging (CTI) Safety Form.
* Clinical Institute of Withdrawal Assessment in Alcohol Withdrawal (CIWA-Ar) scores of 10
Exclusion Criteria:
* History of moderate to severe TBI
* Documented and verified history of psychotic spectrum disorders (i.e., schizophrenia, bipolar)
* Receipt of anti-epileptic medications to control active seizures or evidence of documented seizure within past six months
* Receipt of tricyclic anti-depressants, antipsychotic agents, or other drugs that lower the seizure threshold
* Current use of:
* opiates
* cocaine
* amphetamines
* barbiturates
* benzodiazepine
* marijuana/cannabis dependence as determined by the SCID-IV
* Currently prescribed any anti-craving/addiction medications, i.e.:
* naltrexone
* varenicline
* bupropion
* disulfiram
* acamprosate
* Meet questionable validity or malingering criteria on the Minnesota Multiphasic Personality Inventory-2-RF (MMPI-2-RF; F: T score 107; F(p): T score 85; TRIN: T score 80; VRIN: T score 80) or the Letter Memory Test (LMT; total score 92%), as determined in IRB#13-077
* Pregnant or nursing
* Have congestive heart failure
* Have cardiac pacemaker or defibrillator, or:
* cochlear implant
* nerve stimulator
* intracranial metal clips
* implanted medical pump
* increased intracranial …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial targets people dealing with alcohol use disorder alongside mild traumatic brain injury and PTSD all at once — given my specific combination of diagnoses, is my situation close enough to what this study is designed for that it would even be worth pursuing?
2Since this is a Phase 2 pilot study, what does that mean for how much is already known about whether rTMS is safe and effective for someone with both a brain injury history and alcohol use disorder — and how does that uncertainty compare to standard treatment options I could try instead?
3The trial is actively enrolling but no longer recruiting new participants — does that mean there's any realistic chance of getting involved, or should we focus our energy on finding other options?
4One of the main things this study is measuring is how often adverse events happen with rTMS in this population — given that I have a history of mild TBI, are there specific side effects or risks from brain stimulation that you'd want me to understand before considering this?
5The study is also tracking alcohol craving levels using a standardized scale — if I were a candidate, how would you weigh a potential reduction in cravings from an experimental approach like this against what behavioral therapy or medication-assisted treatment might already offer me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Penn Alcohol Craving Scale Change
Timeframe: baseline, immediately after last/10th rTMS session, and 1 day, 1 week, and 1 month follow-up
2
Total Adverse Event Frequency
Timeframe: immediately after last/10th rTMS session - up to 2 weeks
3
Total rTMS Sessions Completed
Timeframe: after the 10th and last rTMS treatment session - up to 2 weeks