A Prospective, Double Blind, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) for Treatment and Reduction of Heavy Drinking in Individuals With Alcohol Use Disorder (AUD)

Summary

The study will compare alcohol use in two groups of subjects. One group will be assigned to the Deep TMS treatment and the other group will be assigned to the sham treatment. This is a prospective, 6-month, double blind, randomized, controlled, multi-center trial in outpatients recruited in both academic and private research centers. The study population will consist of subjects diagnosed with moderate to severe AUD. The study is comprised of three phases: 1. Pre-study Screening and Baseline Phase 2. Acute Treatment Phase and 3. Maintenance Treatment and Follow up Phase Subjects of all ethnic and gender categories, ages ranging between 18-86 years will be screened for study eligibility according to the inclusion and exclusion criteria. Subjects who meet the eligibility criteria and are willing to sign an informed consent form will be enrolled in the study. The subjects' demographic and baseline characteristics, as well as their overall medical condition will be assessed prior to treatment administration. Eligible patients will be randomized with a 1:1 ratio to one of two study groups (treatment or sham) and stratified by site. Randomization will be employed to avoid bias in the assignment of subjects to treatment group. All subjects will undergo the same treatment regimen, regardless of the assigned treatment group. The acute treatment phase will include 15 treatment visits over a period of 3-5 weeks. The Maintenance Treatment \& Follow-up phase will include one treatment visit per week from the end of the Acute Treatment Phase until the 6 month follow-up visit. At each treatment session, prior to stimulation onset, alcohol related cues will be presented to the subject. After the offset of the alcohol cue presentation, active or sham Deep TMS stimulation will be administered. The study design is directed towards a comparison between active treatment and sham, up to 4 months and 6 months follow-up. Efficacy will be assessed using the primary efficacy measure of the percent heavy drinking days during months 2, 3 and 4, based on the Time Line Follow Back (TLFB) reporting and supportive PEth results. Additionally, several subject assessment scales will be used during the course of the study to assess alcohol use and alcohol craving. Safety will be assessed, including monitoring the severity, causality and frequency of all adverse events, vital signs, and physical and neurological examination.

Eligibility

Age range

18–86 years

Sex

All

Healthy volunteers

No

Interventions

• Device
  Deep TMS (DTMS)

  The Deep TMS group will receive 30 active sessions in 15 visits (i.e., 2 treatments per visit) over a period of 3-5 weeks in the Acute Treatment Phase. In the Maintenance Treatment \& Follow-up phase subjects will receive one treatment session per week from the end of the Acute Treatment Phase until the 6-month follow-up visit. All treatment sessions will consist of 2 treatments per day with a 30 minute interval in between. Each treatment will last approximately 20 minutes.

• Device
  Sham (No Treatment)

  The control group will receive 30 Sham sessions in 15 visits (i.e., 2 treatments per visit) over a period of 3-5 weeks in the Acute Treatment Phase. In the Maintenance Treatment \& Follow-up phase subjects will receive one treatment session per week from the end of the Acute Treatment Phase until the 6-month follow-up visit. All treatment sessions will consist of 2 treatments per day with a 30 minute interval in between. The control group will receive inactive/sham treatment with identical parameters to the Deep TMS treatment.

Locations (9)