SAINT in Postpartum Depression (PPD)

NANot yet recruitingINTERVENTIONAL
Enrollment

192

Participants

Timeline

Start Date

November 1, 2025

Primary Completion Date

April 30, 2029

Study Completion Date

October 31, 2029

Conditions
Postpartum Depression (PPD)
Interventions
DEVICE

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.

DEVICE

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.

Trial Locations (4)

10029

Icahn School of Medicine at Mount Sinai, New York

29425

The Medical School of South Carolina (MUSC), Charleston

78712

University of Texas at Austin, Austin

01655

UMass Chan Medical School, Worcester

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Congressionally Directed Medical Research Programs

FED

lead

Magnus Medical

INDUSTRY

NCT07210255 - SAINT in Postpartum Depression (PPD) | Biotech Hunter | Biotech Hunter