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NOT YET RECRUITING
NCT07804459
EARLY_PHASE1

Individualized fMRI-guided TMS for Depression

Sponsor: Desmond Oathes

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn how transcranial magnetic stimulation (TMS) affects brain circuits involving the subgenual anterior cingulate cortex (sgACC) in adults with depression. The main questions it aims to answer are: * Can brain responses in the sgACC before treatment predict improvement in depressive symptoms following TMS? * Does a 6-week course of active TMS, compared with sham TMS, change brain responses in the sgACC? * Are changes in sgACC responses during treatment associated with changes in depressive symptoms? Researchers will compare active TMS with sham TMS to evaluate changes in the targeted brain circuit and depressive symptoms. Participants will: * Receive active or sham TMS every weekday for 6 weeks * Undergo MRI scans with TMS before, during, and after the 6-week intervention to measure brain responses to stimulation * Complete clinical assessments, questionnaires, and cognitive testing * Complete follow-up assessments after the intervention

Official title: Engaging the Subgenual Cingulate With Brain Stimulation for Depression

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-09-15

Completion Date

2028-08-31

Last Updated

2026-09-04

Healthy Volunteers

No

Interventions

DEVICE

Active Repetitive Transcranial Magnetic Stimulation (rTMS)

The TMS intervention will involve two sets of intermittent theta-burst stimulation (iTBS) delivered every weekday for 6 weeks (30 sessions). Each iTBS set consists of 40 trains and 1,200 pulses, for a total of 2,400 pulses per treatment session. The two iTBS sets will be separated by approximately 5 minutes and delivered to the individualized cortical target selected based on positive resting-state functional connectivity with the subgenual anterior cingulate cortex (sgACC) using MRI-guided neuronavigation.

DEVICE

Sham Transcranial Magnetic Stimulation (TMS)

The sham TMS intervention will follow the same treatment schedule and session structure as active TMS. Sham stimulation will be delivered using the shielded side of the TMS coil together with synchronized scalp electrical stimulation to mimic the sensation of active TMS without delivering the intended magnetic stimulation to the targeted brain region.

Locations (1)

University of Pennsylvania

Philadelphia, Pennsylvania, United States