Pilot rTMS for AUD+mTBI

NCT03995173 | Active Not Recruiting Phase 2 FDA Device

• 2 other identifiers: B0949-WIK2RX000949
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot randomized controlled trial (RCT) for Veteran participants with alcohol use disorder co-occurring with mild traumatic brain injury and/or post-traumatic stress disorder. The treatment intervention is repetitive Transcranial Magnetic Stimulation (rTMS) and the goal is to reduce alcohol craving with this treatment. The study will enroll 20 Veteran participants. Half of these participants will receive real rTMS and half of the participants will receive placebo rTMS. rTMS treatment will be provided over 10 sessions that will occur once every weekday for 2 weeks. Veteran participants will then complete follow-up phone calls to further evaluate alcohol craving and other symptoms.

Conditions

Alcohol Use Disorder; Mild Traumatic Brain Injury; Post-traumatic Stress Disorder

Keywords

alcoholism; brain concussion; post-traumatic stress disorder

Outcome Measures

Primary Outcomes (3)

• Penn Alcohol Craving Scale Change

  5-item self-report measure of alcohol craving and each item is scored on a scale of 0 to 6. The minimum total score is 0 and the maximum is 30, indicating less to more severe alcohol craving, respectively.

  baseline, immediately after last/10th rTMS session, and 1 day, 1 week, and 1 month follow-up

• Total Adverse Event Frequency

  An adverse event log will be kept for each participant and each rTMS treatment session. After each treatment these events will be recorded and the total frequency of events will be used as the outcome after all 10 rTMS sessions over the course of the 2 week treatment have been completed.

  immediately after last/10th rTMS session - up to 2 weeks

• Total rTMS Sessions Completed

  Total number of rTMS treatment sessions completed out of 10 sessions. After all 10 rTMS sessions over the course of the 2 week treatment this cumulative total number of sessions complete can be computed.

  after the 10th and last rTMS treatment session - up to 2 weeks

Study Arms (2)

active

ACTIVE COMPARATOR

active rTMS

Device: repetitive transcranial magnetic stimulation

placebo

PLACEBO COMPARATOR

placebo rTMS

Device: repetitive transcranial magnetic stimulation

Interventions

repetitive transcranial magnetic stimulation DEVICE

rTMS will be delivered with the Magventure MagProX100 with MagOption stimulator and Magpro Cool Coil B65 A/P. The Magpro Cool Coil B65 A/P can be switched to active or placebo (A/P). The Magventure C-B60 coil will be used to deliver single TMS pulses for motor threshold determination.

Also known as: transcranial magnetic stimulation

active; placebo

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English Speaking
• Veterans
• Ages 22 through 65
• Meeting AUDIT-C criteria for AUD (4 for men and 3 for women)
• Pass MRI screening using the Center for Translational Imaging (CTI) Safety Form.
• Clinical Institute of Withdrawal Assessment in Alcohol Withdrawal (CIWA-Ar) scores of 10

You may not qualify if:

• History of moderate to severe TBI
• Documented and verified history of psychotic spectrum disorders (i.e., schizophrenia, bipolar)
• Receipt of anti-epileptic medications to control active seizures or evidence of documented seizure within past six months
• Receipt of tricyclic anti-depressants, antipsychotic agents, or other drugs that lower the seizure threshold
• Current use of:
• opiates
• cocaine
• amphetamines
• barbiturates
• benzodiazepine
• marijuana/cannabis dependence as determined by the SCID-IV
• Currently prescribed any anti-craving/addiction medications, i.e.:
• naltrexone
• varenicline
• bupropion

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, 60141-3030, United States

Location

MeSH Terms

Conditions

Alcoholism; Brain Concussion; Stress Disorders, Post-Traumatic

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Amy A Herrold, PhD BA

  Edward Hines Jr. VA Hospital, Hines, IL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A unblinded member(s) of the research team will be provided with randomization codes from the study biostatistician. A unblended research team member will then provide the PI and rTMS treatment providers with a specific code for the rTMS device. rTMS providers enter the specific rTMS code into the rTMS device and the device is designed to deliver active or placebo rTMS based on this code. The rTMS device is designed to deliver placebo rTMS that looks, sounds and feels like active rTMS.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Double-blind, randomized controlled trial of two parallel groups: active and placebo rTMS

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: June 21, 2019
• Study Start: March 21, 2019
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)