CompletedNCT03829761Updated Oct 23, 2023

Cerebellar Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Alcohol Use Disorder

An interventional study of Repetitive transcranial magnetic stimulation (rTMS) and Sham transcranial magnetic stimulation in Alcohol Use Disorder, sponsored by The Mind Research Network. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-10-23.

Sponsored by The Mind Research Network · Not applicable, Interventional, and Treatment

From the registry’s dates

Primary completion was Sep 2023, 3 years 1 month ago, and no results have been posted to the registry.

Phase: Not applicable
Study type: Interventional
Enrollment: 24
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study summary

The objective of the current study is to investigate the effects of repetitive transcranial magnetic stimulation (rTMS) on self-reported negative affect, cerebellar brain activation and alcohol use outcomes in alcohol use disorder (AUD).

Read the detailed description

To achieve study aims, 34 treatment seeking adults with AUD will be recruited from local intensive outpatient (IOP) treatment programs and randomized to treatment with either inhibitory 1Hz rTMS to cerebellar vermis given daily for 2 weeks (total of 10 sessions) or sham. Alcohol use outcomes, self-reported negative affect, and craving will be obtained at baseline, 1 day, 1 week and 6 weeks following rTMS termination. An fMRI scan during a Stroop task will be obtained at baseline and 1 day after the final rTMS session.

Conditions studied

Alcohol Use Disorder

Browse trials for

Alcoholism 1,634

Keywords

rTMS

In context

Alcoholism

1,634 studies on the registry are indexed under Alcoholism; 329 are open to participants now.

This study's enrollment of 24 is below the median of 88 across 1,395 interventional studies indexed under Alcoholism.

Browse Alcoholism studies →

Lead sponsor

The Mind Research Network is the lead sponsor of 18 studies on the registry; 5 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 4 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Males and females age 18-65 meeting DSM-V criteria for moderate or severe AUD in the past year;
Interested in cutting down or quitting drinking;
Able to provide voluntary informed consent;
Have at least 4 heavy drinking days (≥ 5 drinks per day for men, and ≥4 for women) in the past 60 days;
Currently receiving treatment for alcohol use disorder.

Exclusion criteria

Exclusion Criteria:

Severe neurological conditions (TBI/stroke/history of a seizure/dementia and other significant cognitive illnesses);
Other urgent medical problems, as determined by the study physician from the history and physical exam;
Schizophrenia, schizoaffective disorder, bipolar I disorder
Suicidal thoughts (intent or plan) in the last month;
Current moderate or severe other SUD (except nicotine or marijuana) or other drug (except nicotine or marijuana) use in the past month;
Active legal problems with the potential to result in incarceration;
Pregnancy or lactation, or child bearing age and sexually active but not on birth control (barrier methods allowed);
Current daily use of anti-craving medications, antidepressants (at doses considered therapeutic for depression), benzodiazepines, antipsychotics (at doses considered therapeutic for psychosis or mood stabilization), mood stabilizers (at doses considered therapeutic for mood stabilization);
Have previously undergone rTMS (to assure the blind is effective);
Personal or familial (in first degree relatives) history of epilepsy;
Any contraindication for Magnetic Resonance Imaging (MRI) or TMS including metal shards or certain implants (pacemakers etc.) in the body.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 24 participants (actual)

Study arms

Experimental
Cerebellar rTMS
Cerebellar rTMS. 1Hz repetitive transcranial magnetic stimulation (rTMS) to cerebellar vermis.
Device: Repetitive transcranial magnetic stimulation (rTMS)
Sham comparator
Sham TMS
Sham TMS. Sham transcranial magnetic stimulation to cerebellar vermis.
Device: Sham transcranial magnetic stimulation

Interventions

DeviceRepetitive transcranial magnetic stimulation (rTMS)
Repetitive transcranial magnetic stimulation (rTMS). Participants will undergo 10 daily sessions (Mon-Fri) of 30 minutes of 1Hz stimulation, for a total of 1800 pulses delivered.
DeviceSham transcranial magnetic stimulation
Sham transcranial magnetic stimulation (TMS). Participants will undergo 10 daily sessions (Mon-Fri) of 30 minutes of sham stimulation. Sham stimulation will imitate the active rTMS but does not have active stimulation.

What researchers measure

Primary outcomes

Time to drinking relapse as measured by the Time Line Follow Back
Time to drinking relapse as measured by the Time Line Follow Back from baseline in days.
Time frame: 8 weeks
Change in percent days abstinent as measured by the Time Line Follow Back
Change in percent days abstinent as measured by the Time Line Follow Back from the 90 days prior to day 1 to day 14-21 (post-treatment).
Time frame: 3 weeks
Change in self reported negative affect as measured by the Promise anger, anxiety and depression scales
Change in self reported negative affect as measured by the Promise anger, anxiety and depression scale T scores from baseline to day 15 (post-treatment).
Time frame: 2 weeks
Change in cerebellar brain activation as indicated by percent signal change in the medial cerebellum during incongruent minus congruent trials during a multisensory Stroop task during fMRI
Change in cerebellar brain activation as indicated by percent signal change in the medial cerebellum during incongruent minus congruent trials during a multisensory Stroop task during fMRI from baseline to day 15 (post-treatment). This will be calculated using a mask derived from preliminary data from a sample of 33 individuals with AUD at a single timepoint. Activation in this brain region was correlated with depression, anxiety, and recent drinking. Manuscript describing this result is under review (Wilcox et al.), and another manuscript describes the task in question (Wilcox et al. 2014 Cognitive Control Network Function in Alcohol Use Disorder Before and During Treatment With Lorazepam. Subst Use Misuse.
Time frame: 2 weeks

Study locations

1 site

The Mind Research Network
Albuquerque, New Mexico 87106, United States

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2019 to primary completion in Sep 2023, 54 months.

Of 459 non-industry interventional studies with no phase under Alcoholism, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 56. This study's 54 months is above that.

Counting every sponsor, half of 482 studies reached it within 34 months; a quarter within 17 and three quarters within 54.

How these figures are worked out, and which studies are left out of them.

Registered: Nov 7, 2018
First posted: Feb 4, 2019
StartActual: Feb 20, 2019
Primary completionActual: Sep 7, 2023
CompletionActual: Sep 7, 2023
Last update: Oct 23, 2023

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Oct 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03829761
Lead sponsor: The Mind Research Network
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Responsible party: Jon Houck (Associate Professor of Translational Neuroscience, The Mind Research Network) — Principal investigator
First posted: Feb 4, 2019
Start date: Feb 20, 2019
Primary completion: Sep 7, 2023
Completion: Sep 7, 2023
Last update: Oct 23, 2023

Study contacts

Jon M Houck, PhD

principal investigator · The Mind Research Network

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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