186
Participants
Start Date
November 7, 2025
Primary Completion Date
November 1, 2027
Study Completion Date
December 1, 2027
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.
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.
ManuMind Interventional Psychiatry, Woodbury
PsyCare, South Charleston
DTMS Center LLC, West Palm Beach
Alpha Neuron LLC, Tuscaloosa
Rosecrance River North, Chicago
Soroka Medical Center, Beersheba
Lead Sponsor
Brainsway
INDUSTRY