Your session is about to expire
← Back to Search
Other
Magnetic Brain Stimulation for TBI and Alcoholism (rTMS-TARGET-ID Trial)
Phase 2
Recruiting
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
Meets Symptom Attribution and Classification (SACA) criteria (Pape, Herrold et al 2016, JHTR) for mTBI (without requirement of clinical neuropsychological impairment)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 6 months
Awards & highlights
rTMS-TARGET-ID Trial Summary
This trial is testing whether a new target for magnetic brain stimulation can improve function for veterans with both traumatic brain injury and alcohol use disorder.
Who is the study for?
This trial is for Veterans who can read and speak English, have been diagnosed with alcohol use disorder (AUD) and mild traumatic brain injury (mTBI) according to specific criteria. They shouldn't have severe TBI, neurodegenerative diseases, psychotic disorders, low IQ scores (<70), or recent drug abuse. Pregnant/nursing individuals or those with MRI contraindications are excluded.Check my eligibility
What is being tested?
The study aims to find a unique neural target in Veterans with AUD+mTBI for rTMS treatment to improve functional recovery. It will test the effectiveness of this target using the Magventure MagProX100 stimulator and Cool Coil B65 A/P as part of advancing rehabilitative health care in VAs nationwide.See study design
What are the potential side effects?
While not explicitly listed here, common side effects of rTMS may include headaches, scalp discomfort at the stimulation site, tingling or spasms of facial muscles, lightheadedness, and rare risk of seizure.
rTMS-TARGET-ID Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a mild traumatic brain injury according to SACA criteria.
rTMS-TARGET-ID Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
World Health Organization Disability Assessment Schedule 2.0 (WHODAS) Change
rTMS-TARGET-ID Trial Design
4Treatment groups
Active Control
Group I: Active + Placebo rTMS for Custom Neural Target Group 2Active Control1 Intervention
Custom neural anatomical target 2 defined by neuroimaging data
Group II: Active + Placebo rTMS for Custom Neural Target Group 1Active Control1 Intervention
Custom neural anatomical target 1 defined by neuroimaging data
Group III: Active + Placebo rTMS for Custom Neural Target Group 3Active Control1 Intervention
Custom neural anatomical target 3 defined by neuroimaging data
Group IV: Active + Placebo rTMS for Left DLPFC Neural TargetActive Control1 Intervention
Neural anatomical target will be the Left Dorsolateral Prefrontal Cortex identified using the 5cm from the motor "hot spot" rule.
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,610 Previous Clinical Trials
3,305,084 Total Patients Enrolled
41 Trials studying Alcoholism
6,239 Patients Enrolled for Alcoholism
Amy A Herrold, PhD BAPrincipal InvestigatorEdward Hines Jr. VA Hospital, Hines, IL
2 Previous Clinical Trials
20 Total Patients Enrolled
1 Trials studying Alcoholism
1 Patients Enrolled for Alcoholism
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been identified as not putting in enough effort during the testing or have not been truthful about your symptoms.You have been diagnosed with schizophrenia, schizoaffective disorder, or bipolar disorder.I have a mild traumatic brain injury according to SACA criteria.You have used certain drugs like benzodiazepines, opiates, cocaine, or amphetamines in the last 30 days.You have had a serious head injury in the past.I have a neurodegenerative condition like Alzheimer's, Parkinson's, or MS.You have a significant problem with using cannabis, according to specific guidelines.I don't have conditions that prevent me from undergoing an MRI.You meet the criteria for Alcohol Use Disorder according to the DSM-5.
Research Study Groups:
This trial has the following groups:- Group 1: Active + Placebo rTMS for Custom Neural Target Group 2
- Group 2: Active + Placebo rTMS for Custom Neural Target Group 1
- Group 3: Active + Placebo rTMS for Custom Neural Target Group 3
- Group 4: Active + Placebo rTMS for Left DLPFC Neural Target
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
How can I become a part of this research project?
"This study is looking for 100 individuals that suffer from alcoholism. The patients must be aged between 22 and 65 and should meet the DSM-5 criteria for AUD."
Answered by AI
Are people of all ages eligible for this experiment?
"Enrolment in this particular medical trial is restricted to adults aged 22 to 65. There are 114 other trials available for minors and 496 that focus on senior citizens."
Answered by AI
Are patients currently being enrolled in this trial?
"Yes, the study is currently ongoing and recruiting patients. According to the clinicaltrials.gov website, where this information is hosted, the trial was posted on 01/01/2019 and last updated on 03/23/2022. They are looking for 100 volunteers across 1 site."
Answered by AI
Does the FDA endorse this medication?
"While Phase 2 trials are not as reliable in terms of efficacy, the safety data gathered thus far rates this treatment a 2."
Answered by AI
How many research participants are you enrolling in this clinical trial?
"That is correct, the listing on clinicaltrials.gov shows that this research is ongoing and currently looking for 100 subjects from 1 site."
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
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger