NCT03969251

Transcranial Magnetic Stimulation (TMS) Treatment for Alcohol Use Disorder

Optimizing Treatment for Alcohol Use Disorder (AUD) Using Targeted Transcranial Magnetic Stimulation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Nassima Ait-Daoud Tiouririne · Academic / Other
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

This is a pilot study designed to evaluate the efficacy of High Frequency (HF) repetitive transcranial magnetic stimulation (rTMS) of the left dorsolateral prefrontal cortex (L-DLPFC) at improving cognitive flexibility in recently detoxified individuals with alcohol use disorder (AUD) compared to placebo (Sham rTMS). The total number of subjects requested to be randomized is 20. The investigator will need to screen about 40 subjects to have 20 subjects started on rTMS session at a ratio of 2 screens/1 subject randomized.

Detailed description

This is a randomized double- blind, control study. To test the hypothesis, the investigator propose a 2 phase design: Phase 1: 6-week trial comparing the efficacy of active high-frequency (HF) rTMS of L-DLPFC versus sham (SS) rTMS to determine if HF rTMS improves cognitive flexibility in recently detoxified alcoholics Phase 2: at the end of TMS phase, all participants will receive cognitive behavioral therapy (CBT) thus permitting participants with AUD to benefit from cognitive restructuring in CBT, and reduce alcohol cravings and drinking outcomes. This study will recruit 20 individuals with AUD, comprising of both male and female participants, age 22 years and older interested in alcohol drinking abstinence. Participants will be recruited from the inpatient unit upon discharge after receiving a detoxification treatment and therefore will be abstinent at study entry. Prior to treatment onset and weekly throughout the course of treatment, participants will complete cognitive testing/measures, Wisconsin Card Sorting Task (WCST), Dimensional Change Card Sort Task (DCCST), Barratt Impulsiveness Scale (BIS), Flanker Inhibitory Control and Attention Test (FICAT), and List Sorting Working Memory Test (LSWMT) and self-reported craving measures, Alcohol Craving Questionnaire (ACQ-Now), and Obsessive Compulsive Drinking Scale (OCDS). The drinking timeline follow-back, and adverse events will also be assessed weekly for 8 weeks. Participant will be randomized to either high frequency (HF) or sham repetitive transcranial magnetic stimulation (SS rTMS), which will be done 5 days per week for 6 weeks. At the end of 6 weeks, all participants will receive weekly CBT for a total of 8 weeks. Participants will return at 2 and 4 weeks for follow-up assessments.

Conditions

• Alcoholism

Interventions

Type	Name	Description
DEVICE	Transcranial Magnetic Stimulation (rTMS)	active high frequency repetitive TMS of left Dorsolateral Prefrontal Cortex
DEVICE	Sham (SS)	repetitive sham rTMS

Timeline

• Start date: 2019-07-01
• Primary completion: 2021-03-01
• Completion: 2021-06-01
• First posted: 2019-05-31
• Last updated: 2020-10-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study