Individualized fMRI-guided TMS for Depression

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor: Desmond Oathes
Study ID: NCT07804459
Phase: EARLY_PHASE1
Status: Not Yet Recruiting

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Conditions

Depression
Depression - Major Depressive Disorder
MDD
Major Depressive Disorder (MDD)
PDD
Persistent Depressive Disorder

Eligibility Criteria

Sex: ALL
Age: 18 Years - 65 Years
Healthy Volunteers: Not accepted

Interventions

Active Repetitive Transcranial Magnetic Stimulation (rTMS) — DEVICE
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.
Sham Transcranial Magnetic Stimulation (TMS) — DEVICE
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.

Study Details

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

Key Dates

First listed: Sep 4, 2026
Start date: Sep 15, 2026
Status verified: Aug 2026
Primary completion: Jun 30, 2028
Completion: Aug 31, 2028

Study Design

Enrollment: 60 participants (estimated)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Arms

Experimental: Active iTBS
Participants will receive active intermittent theta burst stimulation (iTBS) delivered to an individualized cortical target selected based on positive resting-state functional connectivity with the subgenual anterior cingulate cortex (sgACC). Active iTBS will be administered every weekday for 6 weeks (30 sessions) and is intended to stimulate the targeted cortical-sgACC circuit.
Sham Comparator: Sham iTBS
Participants will receive sham iTBS at the same individualized cortical target selected based on positive resting-state functional connectivity with the subgenual anterior cingulate cortex (sgACC) every weekday for 6 weeks (30 sessions).