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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
Must not have
Neurodegenerative disease (e.g., Alzheimer's disease, Parkinson's disease, multiple sclerosis)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 6 months
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a mild traumatic brain injury according to SACA criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a neurodegenerative condition like Alzheimer's, Parkinson's, or MS.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
World Health Organization Disability Assessment Schedule 2.0 (WHODAS) Change

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
1,668 Previous Clinical Trials
3,765,766 Total Patients Enrolled
43 Trials studying Alcoholism
5,995 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

Magventure MagProX100 with MagOption stimulator and Magpro Cool Coil B65 A/P (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04043442 — Phase 2
Alcoholism Research Study Groups: Active + Placebo rTMS for Custom Neural Target Group 2, Active + Placebo rTMS for Custom Neural Target Group 1, Active + Placebo rTMS for Custom Neural Target Group 3, Active + Placebo rTMS for Left DLPFC Neural Target
Alcoholism Clinical Trial 2023: Magventure MagProX100 with MagOption stimulator and Magpro Cool Coil B65 A/P Highlights & Side Effects. Trial Name: NCT04043442 — Phase 2
Magventure MagProX100 with MagOption stimulator and Magpro Cool Coil B65 A/P (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04043442 — Phase 2
~7 spots leftby May 2025
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