192
Participants
Start Date
November 1, 2025
Primary Completion Date
April 30, 2029
Study Completion Date
October 31, 2029
SAINT Neuromodulation System
SAINT will be delivered via a MagPro X100 edition (MagVenture, Skovlunde, Denmark) TMS device equipped with a Cool-B65 A/P coil. The stimulation paradigm consists of 10 daily sessions (50 total sessions over 5 days) of SAINT stimulation (3-pulse 50-Hz bursts at 5-Hz for 2-second trains, with trains every 10 seconds), delivered with 50-minute inter-session intervals (10-minute sessions, 50-minutes in between sessions). Stimulation will be administered at 90% of the participant's resting motor threshold, with depth correction applied to adjust for the measured distance between the scalp and cortical surface. The stimulation target, the L-DLPFC, will be identified and localized by the study investigator using the Localite neuronavigation system.
Sham SAINT Stimulation
Sham stimulation will be delivered using the MagVenture MagPro X100 TMS system with the Cool-B65 A/P coil and targeted to the L-DLPFC. The stimulation paradigm will be identical to the active SAINT stimulation with the exception that active stimulation will not be delivered.
Icahn School of Medicine at Mount Sinai, New York
The Medical School of South Carolina (MUSC), Charleston
University of Texas at Austin, Austin
UMass Chan Medical School, Worcester
Lead Sponsor
Congressionally Directed Medical Research Programs
FED
Magnus Medical
INDUSTRY