Trial Outcomes & Findings for Transcranial Magnetic Stimulation for the Treatment of Veterans With Alcohol Use Disorders (NCT NCT03191266)
NCT ID: NCT03191266
Last Updated: 2026-01-28
Results Overview
For the 6 months following completion of active or sham rTMS treatment, participants were contacted monthly, via telephone or in person, to complete a brief standardized measure of alcohol and substance use, and psychiatric symptoms to assess for changes in these variables over the previous 30 days.
COMPLETED
NA
49 participants
6 months following last TMS session
2026-01-28
Participant Flow
Eighty-eight Veterans with alcohol use disorder, from a residential treatment program at the VA Palo Alto Health Care System, completed an in-person screen for study eligibility.Thirty-four individuals were not eligible for participation; the most common reasons for exclusion were a history of bipolar or schizophrenia spectrum disorders or moderate or greater severity traumatic brain injury. Five other participants were eligible, but declined to complete the 2-week study procedure.
Eighty-eight Veterans with alcohol use disorder, completed an in-person screen for study eligibility. Thirty-four individuals were not eligible for participation. Five other participants were eligible, but three declined, not wishing to complete neuroimaging procedures, and two did not wish to complete the approximately 2-week iTBS procedure. The final participant group consisted of 49 individuals.
Participant milestones
| Measure |
Active rTMS
Active rTMS will receive an intermittent rTMS stimulation protocol.
|
Sham rTMS
Sham rTMS will receive all conditions except the actual intermittent theta burst rTMS stimulation.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
24
|
|
Overall Study
COMPLETED
|
22
|
22
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Active rTMS
Active rTMS will receive an intermittent rTMS stimulation protocol.
|
Sham rTMS
Sham rTMS will receive all conditions except the actual intermittent theta burst rTMS stimulation.
|
|---|---|---|
|
Overall Study
Space occupying lesion on MRI; PI removed participant after randomization, but before TMS initiation
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
Baseline Characteristics
Transcranial Magnetic Stimulation for the Treatment of Veterans With Alcohol Use Disorders
Baseline characteristics by cohort
| Measure |
Active rTMS
n=25 Participants
Active rTMS will receive an intermittent rTMS stimulation protocol.
|
Sham rTMS
n=24 Participants
Sham rTMS will receive all conditions except the actual intermittent theta burst rTMS stimulation.
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=158 Participants
|
5 Participants
n=157 Participants
|
11 Participants
n=315 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=158 Participants
|
19 Participants
n=157 Participants
|
38 Participants
n=315 Participants
|
|
Age, Continuous
|
50.6 years
STANDARD_DEVIATION 13.8 • n=158 Participants
|
51.3 years
STANDARD_DEVIATION 13.8 • n=157 Participants
|
51.0 years
STANDARD_DEVIATION 13.7 • n=315 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=158 Participants
|
1 Participants
n=157 Participants
|
1 Participants
n=315 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=158 Participants
|
23 Participants
n=157 Participants
|
48 Participants
n=315 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
3 Participants
n=315 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=158 Participants
|
1 Participants
n=157 Participants
|
2 Participants
n=315 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=158 Participants
|
1 Participants
n=157 Participants
|
1 Participants
n=315 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=158 Participants
|
5 Participants
n=157 Participants
|
8 Participants
n=315 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=158 Participants
|
17 Participants
n=157 Participants
|
35 Participants
n=315 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=158 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=315 Participants
|
|
Formal education
|
14.3 years
STANDARD_DEVIATION 2.4 • n=158 Participants
|
14.0 years
STANDARD_DEVIATION 1.6 • n=157 Participants
|
14.2 years
STANDARD_DEVIATION 2.0 • n=315 Participants
|
PRIMARY outcome
Timeframe: 6 months following last TMS sessionFor the 6 months following completion of active or sham rTMS treatment, participants were contacted monthly, via telephone or in person, to complete a brief standardized measure of alcohol and substance use, and psychiatric symptoms to assess for changes in these variables over the previous 30 days.
Outcome measures
| Measure |
Active rTMS
n=22 Participants
Active rTMS will receive an intermittent rTMS stimulation protocol.
|
Sham rTMS
n=22 Participants
Sham rTMS will receive all conditions except the actual intermittent theta burst rTMS stimulation.
|
|---|---|---|
|
Number of Participants Who Abstained From Alcohol
|
13 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: This grouping within the active rTMS arm (Abstinent or Resumed alcohol consumption during the 6 month follow-up period) was conducted to determine if baseline glutamate level can serve as a biomarker to differential those participants, in the active rTMS group who main continuous abstinence versus those who resumed alcohol consumption. The investigators did not hypothesize that baseline glutamate would predict outcome (abstinent vs. resumed) in the sham rTMS group.
Determine if baseline glutamate level can serve as a biomarker to differential those participant, in the active rTMS group who main continuous abstinence versus those who resumed alcohol consumption.
Outcome measures
| Measure |
Active rTMS
n=8 Participants
Active rTMS will receive an intermittent rTMS stimulation protocol.
|
Sham rTMS
n=6 Participants
Sham rTMS will receive all conditions except the actual intermittent theta burst rTMS stimulation.
|
|---|---|---|
|
Glutamate Concentration in the Left Dorsolateral Prefrontal Cortex (as Measured With Single Voxel Spectroscopy)
|
26.2 mmol/L
Standard Deviation 2.6
|
19.7 mmol/L
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: BaselinePopulation: This grouping within the active rTMS arm (Abstinent or Resumed alcohol consumption during the 6 month follow-up period) was conducted to determine if baseline left caudal and rostral middle frontal and left superior frontal gyri could gyrus serve as a biomarker to differential those participants, in the active rTMS group, who main continuous abstinence versus those who resumed consumption. We did not hypothesize baseline volumes would predict outcome (abstinent vs. resumed) in the sham group.
Determine if volume in anterior frontal cortical regions can serve as biomarkers to predict rTMS treatment response in Veterans with AUD who receive active TMS. Specific regions of interest were the left caudal and rostral middle frontal gyrus and left superior frontal gyrus because these regions correspond to the rTMS anatomical target.
Outcome measures
| Measure |
Active rTMS
n=9 Participants
Active rTMS will receive an intermittent rTMS stimulation protocol.
|
Sham rTMS
n=8 Participants
Sham rTMS will receive all conditions except the actual intermittent theta burst rTMS stimulation.
|
|---|---|---|
|
Volume in Anterior Frontal Cortical Regions (as Measured With FreeSurfer)
left superior frontal gyrus
|
23503 Volume in cubic millimeters
Standard Deviation 2693
|
21086 Volume in cubic millimeters
Standard Deviation 2729
|
|
Volume in Anterior Frontal Cortical Regions (as Measured With FreeSurfer)
left caudal middle frontal gyrus
|
6587 Volume in cubic millimeters
Standard Deviation 1029
|
6236 Volume in cubic millimeters
Standard Deviation 933
|
|
Volume in Anterior Frontal Cortical Regions (as Measured With FreeSurfer)
left rostral middle gyrus frontal gyrus
|
14778 Volume in cubic millimeters
Standard Deviation 1963
|
14071 Volume in cubic millimeters
Standard Deviation 2549
|
SECONDARY outcome
Timeframe: BaselinePopulation: Analysis was conducted to determine if BDNF polymorphisms (rs6265) can serve as biomarkers to predict rTMS treatment response in Veterans with AUD. Analysis focused on comparing Val homozygote frequency, in active rTMS arm participants, who maintained continuous abstinence (Abstinent) versus those who resumed alcohol consumption (Resumed) over the 6-month follow-up period. We did not have specific hypotheses about BDNF polymorphism rs6265 for abstinence or resumption of alcohol in sham arm.
Determine if BDNF polymorphisms (rs6265) can serve as biomarkers to predict rTMS treatment response in Veterans with AUD. Analysis focused on comparing Val homozygote frequency, in active rTMS arm participants, who maintained continuous abstinence (Abstinent) versus those who resumed alcohol consumption (Resumed) over the 6-month follow-up period. There were a limited number of participants who completed the genotyping procedure; therefore, results are likely not generalizable.
Outcome measures
| Measure |
Active rTMS
n=7 Participants
Active rTMS will receive an intermittent rTMS stimulation protocol.
|
Sham rTMS
n=4 Participants
Sham rTMS will receive all conditions except the actual intermittent theta burst rTMS stimulation.
|
|---|---|---|
|
BDNF Polymorphisms (as Measured With TaqMan Genotyping Assays or Similar Assays)
|
5 Participants
|
4 Participants
|
Adverse Events
Active rTMS
Sham rTMS
Serious adverse events
| Measure |
Active rTMS
n=22 participants at risk
Active rTMS will receive an intermittent rTMS stimulation protocol.
|
Sham rTMS
n=22 participants at risk
Sham rTMS will receive all conditions except the actual intermittent theta burst rTMS stimulation.
|
|---|---|---|
|
Psychiatric disorders
suicide
|
0.00%
0/22 • 1 year post study completion for each participant.
Participant was the under the care of VA clinicians at the time of death and was formally screened for suicidal ideation/intent by different VA clinicians on 9 and 3 days prior to death and denied any suicidal ideation.
|
4.5%
1/22 • Number of events 1 • 1 year post study completion for each participant.
Participant was the under the care of VA clinicians at the time of death and was formally screened for suicidal ideation/intent by different VA clinicians on 9 and 3 days prior to death and denied any suicidal ideation.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place