Safety and Effectiveness of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) for Reducing Heavy Alcohol Drinking in Individuals With Alcohol Use Disorder (AUD)

NANot yet recruitingINTERVENTIONAL
Enrollment

186

Participants

Timeline

Start Date

November 7, 2025

Primary Completion Date

November 1, 2027

Study Completion Date

December 1, 2027

Conditions
Alcohol Use DisorderAlcoholismAlcohol AbuseAlcohol DependenceAlcohol Abuse/DependenceAlcohol Addiction
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.

Trial Locations (6)

11797

ManuMind Interventional Psychiatry, Woodbury

25303

PsyCare, South Charleston

33411

DTMS Center LLC, West Palm Beach

35401

Alpha Neuron LLC, Tuscaloosa

60654

Rosecrance River North, Chicago

8410501

Soroka Medical Center, Beersheba

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Brainsway

INDUSTRY