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Non-invasive Brain Stimulation
rTMS for AUD+mTBI (TMS_AUD+mTBI Trial)
Phase 2
Waitlist Available
Led By Amy A Herrold, PhD BA
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ages 22 through 65
Be older than 18 years old
Must not have
History of: surgery on blood vessels in brain and/or valves of the heart, brain hemorrhage, neurovascular conditions, neurodegenerative disorders, claustrophobia, metal in eye/face, shrapnel/bullet remnants in brain
Receipt of tricyclic anti-depressants, antipsychotic agents, or other drugs that lower the seizure threshold
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, immediately after last/10th rtms session, and 1 day, 1 week, and 1 month follow-up
Awards & highlights
Summary
This trial is testing whether a treatment called repetitive transcranial magnetic stimulation (rTMS) can help reduce alcohol craving in veterans with mild traumatic brain injury and/or post-traumatic stress disorder.
Who is the study for?
This trial is for English-speaking Veterans aged 22-65 with alcohol use disorder (AUD) and mild traumatic brain injury or PTSD. They must pass an MRI safety screening, have specific AUDIT-C scores, and not be in severe alcohol withdrawal. Exclusions include severe TBI, psychotic disorders, seizure history, certain medication use, substance dependence other than alcohol, recent mild TBI or surgery involving the heart/brain vessels.
What is being tested?
The study tests repetitive Transcranial Magnetic Stimulation (rTMS) to reduce alcohol cravings in Veterans with AUD plus mTBI/PTSD. It's a randomized controlled trial where half receive real rTMS and half get placebo over two weeks (10 sessions). Follow-up calls assess craving levels post-treatment.
What are the potential side effects?
While not specified here, common side effects of rTMS may include headache, scalp discomfort at the treatment site during stimulation sessions; rare risks involve seizures or hearing loss if ear protection isn't used.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 22 and 65 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had surgery on my brain's blood vessels or heart valves, or have conditions like brain hemorrhage, neurovascular issues, neurodegenerative disorders, claustrophobia, metal in my eye/face, or shrapnel/bullet remnants in my brain.
Select...
I am taking medication that could increase my risk of seizures.
Select...
I am taking medication to help with cravings or addiction.
Select...
I am taking medication for seizures or have had a seizure in the last 6 months.
Select...
I have been diagnosed with congestive heart failure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, immediately after last/10th rtms session, and 1 day, 1 week, and 1 month follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, immediately after last/10th rtms session, and 1 day, 1 week, and 1 month follow-up
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Penn Alcohol Craving Scale Change
Total Adverse Event Frequency
Total rTMS Sessions Completed
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: activeActive Control1 Intervention
active rTMS
Group II: placeboPlacebo Group1 Intervention
placebo rTMS
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,647 Previous Clinical Trials
3,360,069 Total Patients Enrolled
43 Trials studying Alcoholism
6,093 Patients Enrolled for Alcoholism
Amy A Herrold, PhD BAPrincipal InvestigatorEdward Hines Jr. VA Hospital, Hines, IL
2 Previous Clinical Trials
119 Total Patients Enrolled
1 Trials studying Alcoholism
100 Patients Enrolled for Alcoholism
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a moderate to severe traumatic brain injury in the past.Criterion: Military veteransI am between 22 and 65 years old.You have talked about wanting to hurt yourself or have tried to hurt yourself in the past 6 months.You have been diagnosed with schizophrenia or bipolar disorder.Your CIWA-Ar score is 10 or higher.You drink too much alcohol, as determined by a simple questionnaire.You had a mild head injury in the last 3 months.You have a pacemaker, defibrillator, cochlear implant, nerve stimulator, metal clips in your head, medical pump, or high pressure inside your head.I have had surgery on my brain's blood vessels or heart valves, or have conditions like brain hemorrhage, neurovascular issues, neurodegenerative disorders, claustrophobia, metal in my eye/face, or shrapnel/bullet remnants in my brain.You have shown questionable validity or faking symptoms on specific psychological tests.I am taking medication that could increase my risk of seizures.You are currently using certain drugs like opiates, cocaine, amphetamines, and others.I am taking medication to help with cravings or addiction.I am taking medication for seizures or have had a seizure in the last 6 months.I have been diagnosed with congestive heart failure.
Research Study Groups:
This trial has the following groups:- Group 1: active
- Group 2: placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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