NCT02691390

Deep Repetitive Transcranial Magnetic Stimulation for Alcohol Use Disorder

Exploration of the Potential Role of Anterior Cingulate (ACC) dTMS in Relapse to Alcohol Use

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Soroka University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

dTMS intervention to reduce recurrent alcohol abuse among alcohol users who are abstinent for at least 5 days.

Detailed description

Phase 1: (up to 2 weeks), participants undergo a set of baseline assessments, including questionnaires, rating scales, and resting state functional magnetic resonance imaging (rsfMRI). Phase 2, patients receive one of two treatments: High-frequency (10Hz, 100 trains of 3 sec with 15 sec inter train interval) dTMS targeting the ACC or sham stimulation for 30 min. Each treatment is preceded by provocation (pouring, holding and smelling the subject's favorite alcoholic beverage) designed to activate the relevant brain circuitry (provocation of symptoms may increase response rate to Deep TMS as was evident in the treatment of PTSD, cigarette smoking and OCD). dTMS sessions are conducted five times per week for 3 weeks, for a total of 15 sessions. A second scan that include rsfMRI and a risk-related decision-making task is conducted at the end of this phase. Phase 3 includes 12 weeks of patients' follow-up, including clinical visits at weeks 1, 2, 4, 8 and 12 post treatment. During this phase, subjective and objective measures of alcohol use (self-report and analysis of urine samples for levels of ethyl glucuronide (EtG) and ethyl sulfate (EtS), respectively) are collected. Following completion of the main part by the individual, an "open label" treatment using the same parameters of the experiment is offer (regardless of treatment group).

Conditions

• Alcohol Abuse

Interventions

Type	Name	Description
DEVICE	Active dTMS	dTMS to ACC
DEVICE	Sham dTMS	SHAM - no stimulation

Timeline

• Start date: 2016-07-01
• Primary completion: 2019-12-31
• Completion: 2020-12-01
• First posted: 2016-02-25
• Last updated: 2020-12-29