Theta Burst Stimulation for Alcohol Use Disorder
April 17, 2025 updated by: Gopalkumar Rakesh
The study will examine the effects of two continuous theta burst stimulation (cTBS) sessions (given in a single day) on resting state functional MRI (fMRI), alcohol cue related attentional bias and alcohol craving in patients with alcohol use disorder (AUD).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Although pharmacotherapy and behavioral treatments have been approved for AUD, their effects sizes are modest.
Noninvasive neuromodulation like Transcranial magnetic stimulation (TMS) can offer an alternative treatment option for AUD.
TMS is a method of noninvasive neuromodulation that utilizes a magnetic field to focal electrical current in the brain.
When these electrical currents are focused on specific brain regions, pertinent to the neurobiology of AUD it leads to modulation of behavior and plausibly decrease in alcohol craving and use.
Previous TMS studies have used heterogenous parameters, including frequencies ranging from 1 Hz to 20 Hz.
Regions targeted by these studies encompassed ventromedial prefrontal cortex, left dorsolateral prefrontal cortex (left dlPFC) and right dorsolateral prefrontal cortex.
Two studies used a TMS paradigm with greater efficiency than other routine TMS paradigms, called continuous theta burst stimulation.
These studies delivered 3600 pulses of cTBS to the left frontal pole/ventromedial prefrontal cortex and showed significant reduction in alcohol cue reactivity and corroborative changes in both resting state and task based functional connectivity.
Of these two studies, one was notable in comparing active cTBS (3600 pulses per session, one session every day for ten days over two weeks) versus sham cTBS.
A deep TMS (dTMS) study that compared dTMS (15 sessions, five sessions every week for three weeks) to sham dTMS using an H7 coil (targeting medial prefrontal and anterior cingulate cortices).
This study showed decreased craving after treatment and percentage of heavy drinking days in the active versus sham control group.
Active dTMS was associated with decreased resting-state functional connectivity of the dorsal anterior cingulate cortex with the caudate nucleus and decreased connectivity of the medial prefrontal cortex to the subgenual anterior cingulate cortex.
No study has done multiple sessions of cTBS in a single day.
In addition, no study has previously delivered cTBS to the left dlPFC, to modulate alcohol craving and alcohol cue based attentional bias.
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kentucky
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Lexington, Kentucky, United States, 40513
- 245 Fountain Court
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion criteria.
- Patients seen at a clinic within the University of Kentucky Healthcare
- 21-60 years of age
- male or female gender
- Able to read, understand and communicate in English
- willing to adhere to the general rules of the UK Healthcare
- Must fulfill criteria for moderate alcohol use disorder.
Exclusion criteria
- Positive pregnancy test for females
- traumatic brain injury, history of seizure disorder, history of or current diagnosis of schizophrenia
- intracranial metal shrapnel
- previous adverse effect with TMS
- sub-threshold consistency while performing behavioral tasks
- failure to show baseline attentional bias to alcohol versus neutral cues.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Active cTBS and sham cTBS
There is only one arm in this study and all participants in this arm will receive 2 interventions: active and sham cTBS in a within subject blinded fashion.
They will first receive active cTBS and then sham cTBS, separated by four weeks to minimize carryover effects.
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Two cTBS sessions (each session delivering 3600 pulses) separated by 50 minutes
Other Names:
Two sham cTBS sessions (sham mimics the experimental session but does not deliver any electricity to the brain) separated by 50 minutes
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Penn Alcohol Craving Scale
Time Frame: Before and after two cTBS sessions, approximately 2 hours
|
Craving measured using the Penn alcohol craving scale (PACS) that has five items and is rated on a scale of 1 to 6. Minimum score is 1 and maximum score is 30.
Higher score equates to increased craving
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Before and after two cTBS sessions, approximately 2 hours
|
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Change in Alcohol Cue Attentional Bias
Time Frame: Before and after two cTBS sessions, approximately 2 hours
|
Fixation time on alcohol cues measured using an eye tracker in milliseconds.
Higher score indicates greater attentional bias.
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Before and after two cTBS sessions, approximately 2 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Resting State Functional Connectivity
Time Frame: Before and after two cTBS sessions, approximately 2 hours
|
Number of participants with resting state functional connectivity scans acquired before and after cTBS and sham cTBS
|
Before and after two cTBS sessions, approximately 2 hours
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Gopalkumar Rakesh, PhD, University of Kentucky
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2023
Primary Completion (Actual)
April 17, 2024
Study Completion (Actual)
April 17, 2024
Study Registration Dates
First Submitted
September 22, 2023
First Submitted That Met QC Criteria
September 22, 2023
First Posted (Actual)
September 29, 2023
Study Record Updates
Last Update Posted (Actual)
May 6, 2025
Last Update Submitted That Met QC Criteria
April 17, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 86853
- 2P30CA177558-11 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
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