Theta Burst Stimulation for Alcohol Use Disorder

NCT ID: NCT06060496

Last Updated: 2025-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2024-04-17

Brief Summary

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).

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.

Conditions

Alcohol Use Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Active cTBS

Intervention Type: DEVICE

Two cTBS sessions (each session delivering 3600 pulses) separated by 50 minutes

Sham cTBS

Intervention Type: DEVICE

Two sham cTBS sessions (sham mimics the experimental session but does not deliver any electricity to the brain) separated by 50 minutes

Interventions

Active cTBS

Two cTBS sessions (each session delivering 3600 pulses) separated by 50 minutes

Intervention Type: DEVICE

Sham cTBS

Two sham cTBS sessions (sham mimics the experimental session but does not deliver any electricity to the brain) separated by 50 minutes

Intervention Type: DEVICE

Other Intervention Names

Continuous theta burst stimulation; Continuous theta burst stimulation

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Gopalkumar Rakesh

OTHER

Sponsor Role: lead

Responsible Party

Gopalkumar Rakesh

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Gopalkumar Rakesh, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

245 Fountain Court

Lexington, Kentucky, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

2P30CA177558-11

Identifier Type: NIH

Identifier Source: secondary_id

View Link

86853

Identifier Type: -

Identifier Source: org_study_id