rTMS Target Identification for Functional Disability in AUD+mTBI

Part of paid clinical trials in Hines, Illinois.

Sponsor
VA Office of Research and Development
Study ID
NCT04043442
Phase
PHASE2
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
22 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Magventure MagProX100 with MagOption stimulator and Magpro Cool Coil B65 A/P — DEVICE
    rTMS device

Study Details

The objectives of this VA Merit application are to identify a neural target unique to Veterans with co-occurring alcohol use disorder and mild traumatic brain injury (AUD+mTBI) and to test the efficacy of this target as a stimulation site for repetitive transcranial magnetic stimulation (rTMS) treatment to maximize functional recovery. rTMS will soon be a treatment option at 30 VAs nationwide and preliminary studies show promise for AUD and mTBI treatment. A better understanding of how AUD+mTBI impacts the brain needs to occur in order to advance rTMS to optimize function. This research is aligned with the VA RR\&D's mission to generate knowledge and innovations to advance the rehabilitative health and care of Veterans, to effectively integrate clinical and applied rehabilitation research, and translate research results into practice. This research is also aligned with the goal of the Psychological Health \& Social Reintegration portfolio to develop interventions improving psychological health status of Veterans enabling them to function more fully in society.

Key Dates

Start date
Jan 1, 2019
Status verified
Apr 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active + Placebo rTMS for Custom Neural Target Group 1
    Custom neural anatomical target 1 defined by neuroimaging data
  • Active Comparator: Active + Placebo rTMS for Custom Neural Target Group 2
    Custom neural anatomical target 2 defined by neuroimaging data
  • Active Comparator: Active + Placebo rTMS for Custom Neural Target Group 3
    Custom neural anatomical target 3 defined by neuroimaging data
  • Active Comparator: Active + Placebo rTMS for Left DLPFC Neural Target
    Neural anatomical target will be the Left Dorsolateral Prefrontal Cortex identified using the 5cm from the motor "hot spot" rule.

Primary Outcome Measure

World Health Organization Disability Assessment Schedule 2.0 (WHODAS) Change [ Time Frame: baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Edward Hines Jr. VA Hospital, Hines, ILHinesIllinois60141-3030-

Find similar trials in Hines, IL

By condition
Substance use disorder
By specialty
Behavioral healthAddiction medicine
By research site
Edward Hines Jr. VA Hospital, Hines, IL· Hines, IL

Related Studies