Theta Burst Stimulation for Alcohol Use Disorder

Gopalkumar Rakesh

Status: Completed

Conditions: Alcohol Use Disorder

Treatments: Device: Active cTBS; Device: Sham cTBS

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06060496

2P30CA177558-11 (U.S. NIH Grant/Contract)

86853

Details and patient eligibility

About

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).

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 21 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Active cTBS and sham cTBS

Experimental group

Description:

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.

Treatment:

Device: Sham cTBS

Device: Active cTBS