Theta Burst Stimulation for Alcohol Use Disorder

Alcohol Use Disorder Clinical Trial

Official title:

Theta Burst Stimulation for Alcohol Use Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06060496
• Other study ID #: 86853
• Secondary ID: 2P30CA177558-11
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2023
• Source: University of Kentucky
• Contact: Gopalkumar Rakesh, PhD
• Phone: 859-382-7611
• Email: gopalkumar.rakesh[@]uky.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism

Intervention

Device:
• Active cTBS
Two cTBS sessions (each session delivering 3600 pulses) separated by 50 minutes
• Sham cTBS
Two sham cTBS sessions (sham mimics the experimental session but does not deliver any electricity to the brain) separated by 50 minutes

Locations

Country	Name	City	State
United States	245 Fountain Court	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Gopalkumar Rakesh	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Penn Alcohol Craving Scale	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	Before and after two cTBS sessions, approximately 2 hours
Primary	Change in Alcohol cue attentional bias	Fixation time on alcohol cues measured using an eye tracker in milliseconds. Higher score indicates greater attentional bias.	Before and after two cTBS sessions, approximately 2 hours
Secondary	Resting state functional connectivity	Measured using z score on functional MRI brain scan.	Before and after two cTBS sessions, approximately 2 hours