Individualized fMRI-guided TMS for Depression

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

Conditions

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

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.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Desmond Oathes

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-15

Primary Completion

2028-06-30

Completion

2028-08-31

FDA Device

Yes

Countries

• United States

Study Locations