Alcohol Use DisorderPhase 2TMS_AUD+mTBINCT03995173
Pilot rTMS for AUD+mTBI
A Phase 2 study testing repetitive transcranial magnetic stimulation in people with Alcohol Use Disorder and Mild Traumatic Brain Injury, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Alcohol Use Disorder, Mild Traumatic Brain Injury, Post-traumatic Stress Disorder
- What is being tested?
- repetitive transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2019to 31 Mar 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 36Show fewer
- 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
- disulfiram
- acamprosate
- Meet questionable validity or malingering criteria on the Minnesota Multiphasic Personality Inventory-2-RF (MMPI-2-RF; F: T score 107; F(p): T score 85; TRIN: T score 80; VRIN: T score 80) or the Letter Memory Test (LMT; total score 92%), as determined in IRB#13-077
- Pregnant or nursing
- Have congestive heart failure
- Have cardiac pacemaker or defibrillator, or:
- cochlear implant
- nerve stimulator
- intracranial metal clips
- implanted medical pump
- increased intracranial pressure
- History of:
- surgery on blood vessels in brain and/or valves of the heart
- brain hemorrhage
- neurovascular conditions
- neurodegenerative disorders
- claustrophobia
- metal in eye/face
- shrapnel/bullet remnants in brain
- Actively suicidal as evidenced by plan to harm or recent attempt communicated on the BDI-II or electronic medical record within the past 6 months
- History of mild TBI within the last 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, 60141-3030
About this study
Official title: Brain Targets for Alcohol Craving in Veterans With mTBI
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.
Read the detailed description
Mild traumatic brain injury (mTBI), post-traumatic stress disorder (PTSD) and alcohol use disorder (AUD) are high priority disorders for the Department of Veterans Affairs (VA), in part, because these disorders rarely occur in isolation. The co-occurrence compounds brain impairment and negatively impacts symptom presentation and rehabilitation effectiveness. Veterans with co-occurring AUD, mTBI and/or PTSD have few effective treatment options. Thus, treatment development for these Veterans is of great need. The aim of this protocol is to examine safety, feasibility, and the behavioral and neural effects of an repetitive transcranial magnetic stimulation (rTMS) intervention for Veterans with AUD and co-occurring mTBI and/or PTSD. Behavioral and neural effects of rTMS will be examined after the first rTMS session and after the last rTMS session. The investigators hypothesize that the rTMS intervention will be 1) safe, 2) feasible and 3) efficacious. Specifically, the investigators hypothesize that there will be no adverse events related to the rTMS intervention. The investigators hypothesize that all participants enrolled will successfully complete all rTMS sessions. The investigators hypothesize that participants treated with active rTMS, relative to placebo rTMS, will have reduced alcohol craving severity levels. Finally, the investigators hypothesize that participants treated with active rTMS relative to placebo rTMS will have reduced brain activation in response to alcohol cues and improved functional connectivity after the last rTMS session. This is a prospective, pilot, double-blind randomized controlled trial of the intervention rTMS. There will be 2 groups of Veterans with AUD and co-occurring mTBI and/or PTSD those given 1) active rTMS and those given 2) placebo rTMS. Targeted enrollment for this study is 20 Veterans: n=10 active rTMS and n=10 placebo rTMS. Participants will be screened for safety and evaluated on mental health-related behavioral measures. Eligible participants will be randomized to receive active or placebo rTMS. Participants will then complete motor thresholding (MT) to determine rTMS intensity. Participants will then complete 10 sessions of rTMS. These sessions will be completed once daily on week days over two weeks. TMS pulses will be applied to the left DLPFC at 10Hz rate, 4.9 seconds per train, with inter-train interval of 30 seconds, and a total of 20 trains per session. After the 10th rTMS session, participants will complete an MRI which will last approximately 1hour. A sub-sample of participants will complete an MRI immediately after the first rTMS session. Participants will also repeat the mental health behavioral measures after the last rTMS session. Participants will complete follow-up phone interviews to assess for alcohol craving, mTBI symptoms and PTSD symptoms at one day, one week and one month post-rTMS. Completion of this study is an essential first step towards treatment development for Veterans with co-occurring AUD, mTBI and/or PTSD.
- Being tested
- repetitive transcranial magnetic stimulation
- Keywords
- alcoholism, brain concussion, post-traumatic stress disorder
- Medical subject headings
- Alcoholism, Brain Concussion, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive transcranial magnetic stimulationDevice
Also called transcranial magnetic stimulation
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.
| Study group | Role | What they receive |
|---|---|---|
| active | Active comparator | active rTMS Receives: Device: repetitive transcranial magnetic stimulation |
| placebo | Placebo comparator | placebo rTMS Receives: Device: repetitive transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: after the 10th and last rTMS treatment session - up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2019
- Study start21 Mar 2019
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, randomized controlled trial of two parallel groups: active and placebo rTMS
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Amy A Herrold, PhD BA, Principal investigator, Edward Hines Jr. VA Hospital, Hines, IL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03995173
- Sponsor's protocol ID
- B0949-W
- Other IDs
- IK2RX000949
- Acronym
- TMS_AUD+mTBI
- Status last verified
- Dec 2025
- First submitted
- 16 Apr 2019
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Targets for Alcohol Craving in Veterans With mTBI
- ClinicalTrials.gov ID
- NCT03995173
- Acronym / sponsor ID
- TMS_AUD+mTBI / B0949-W
- Keywords
- alcoholism, brain concussion, post-traumatic stress disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 21 Mar 2019 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 21 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Mild traumatic brain injury (mTBI), post-traumatic stress disorder (PTSD) and alcohol use disorder (AUD) are high priority disorders for the Department of Veterans Affairs (VA), in part, because these disorders rarely occur in isolation. The co-occurrence compounds brain impairment and negatively impacts symptom presentation and rehabilitation effectiveness. Veterans with co-occurring AUD, mTBI and/or PTSD have few effective treatment options. Thus, treatment development for these Veterans is of great need. The aim of this protocol is to examine safety, feasibility, and the behavioral and neural effects of an repetitive transcranial magnetic stimulation (rTMS) intervention for Veterans with AUD and co-occurring mTBI and/or PTSD. Behavioral and neural effects of rTMS will be examined after the first rTMS session and after the last rTMS session. The investigators hypothesize that the rTMS intervention will be 1) safe, 2) feasible and 3) efficacious. Specifically, the investigators hypothesize that there will be no adverse events related to the rTMS intervention. The investigators hypothesize that all participants enrolled will successfully complete all rTMS sessions. The investigators hypothesize that participants treated with active rTMS, relative to placebo rTMS, will have reduced alcohol craving severity levels. Finally, the investigators hypothesize that participants treated with active rTMS relative to placebo rTMS will have reduced brain activation in response to alcohol cues and improved functional connectivity after the last rTMS session. This is a prospective, pilot, double-blind randomized controlled trial of the intervention rTMS. There will be 2 groups of Veterans with AUD and co-occurring mTBI and/or PTSD those given 1) active rTMS and those given 2) placebo rTMS. Targeted enrollment for this study is 20 Veterans: n=10 active rTMS and n=10 placebo rTMS. Participants will be screened for safety and evaluated on mental health-related behavioral measures. Eligible participants will be randomized to receive active or placebo rTMS. Participants will then complete motor thresholding (MT) to determine rTMS intensity. Participants will then complete 10 sessions of rTMS. These sessions will be completed once daily on week days over two weeks. TMS pulses will be applied to the left DLPFC at 10Hz rate, 4.9 seconds per train, with inter-train interval of 30 seconds, and a total of 20 trains per session. After the 10th rTMS session, participants will complete an MRI which will last approximately 1hour. A sub-sample of participants will complete an MRI immediately after the first rTMS session. Participants will also repeat the mental health behavioral measures after the last rTMS session. Participants will complete follow-up phone interviews to assess for alcohol craving, mTBI symptoms and PTSD symptoms at one day, one week and one month post-rTMS. Completion of this study is an essential first step towards treatment development for Veterans with co-occurring AUD, mTBI and/or PTSD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind, randomized controlled trial of two parallel groups: active and placebo rTMS
| Arm | Type | Receives |
|---|---|---|
| active | Active comparator | Device: repetitive transcranial magnetic stimulationactive rTMS |
| placebo | Placebo comparator | Device: repetitive transcranial magnetic stimulationplacebo rTMS |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (36 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| repetitive transcranial magnetic stimulationAlso: transcranial magnetic stimulationrTMS 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. | Device | active, placebo |
Primary outcome
Penn Alcohol Craving Scale Change
Time frame: baseline, immediately after last/10th rTMS session, and 1 day, 1 week, and 1 month follow-up
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.
Total Adverse Event Frequency
Time frame: immediately after last/10th rTMS session - up to 2 weeks
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.
Total rTMS Sessions Completed
Time frame: after the 10th and last rTMS treatment session - up to 2 weeks
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy A Herrold, PhD BA principal investigator
Edward Hines Jr. VA Hospital, Hines, IL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing repetitive transcranial magnetic stimulation in people with Alcohol Use Disorder and Mild Traumatic Brain Injury, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Penn Alcohol Craving Scale Change (time frame: baseline, immediately after last/10th rTMS session, and 1 day, 1 week, and 1 month follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.