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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
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
TMS_AUD+mTBI Trial 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.Check my eligibility
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.See study design
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.
TMS_AUD+mTBI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 22 and 65 years old.
TMS_AUD+mTBI Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Penn Alcohol Craving Scale Change
Total Adverse Event Frequency
Total rTMS Sessions Completed
TMS_AUD+mTBI 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
1,609 Previous Clinical Trials
3,306,602 Total Patients Enrolled
41 Trials studying Alcoholism
6,475 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the criteria for eligibility to participate in this research?
"The requirements for inclusion in this trial include having an alcohol use disorder and being between the ages of 22 and 65. The total amount of participants sought after is 1 individual."
Answered by AI
Are there any openings for participants in this experiment at present?
"The records on clinicaltrials.gov suggest that this trial is no longer actively recruiting, last being updated on April 27th 2022 since its inception in March of 2019. However, over 1684 other studies are currently looking for participants at this time."
Answered by AI
Can active be utilized safely by individuals?
"After assessing the evidence, our team at Power has assigned an assessment score of 2 to active, as it is currently undergoing Phase 2 trials where safety has been partially established but efficacy remains unconfirmed."
Answered by AI
Is geriatric participation accepted in this medical experiment?
"This study is open to participants aged 22 or older and below the age of 65."
Answered by AI
Who else is applying?
What site did they apply to?
Edward Hines Jr. VA Hospital, Hines, IL
What portion of applicants met pre-screening criteria?
Met criteria
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