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
18-65 years old
DSM-5 diagnosis of major depressive (at least 90%) or persistent depressive disorder (no more than 10%) as per SCID clinical interview.
PHQ-9 score = or > than 10 (to maintain minimal severity of symptoms in the MDD sample)
Comprehension of instructions in the English language.
Implanted medical devices, metallic implants, or drug infusion pumps that are not MRI-safe (e.g., aneurysm clips, defibrillators, or cochlear implants)
History of significant medical events (e.g., stroke, seizures, brain scarring) or neurological/neurodevelopmental conditions (e.g., epilepsy) that are contraindications for TMS and MRI or may adversely affect brain function and data interpretation.
Current psychosis, mania, or substance use disorder
Prior failed response to full rTMS or ECT/MST trial. Any successful prior treatments are acceptable and support a prognosis that a new rTMS treatment would be worth attempting.
Parallel
Active Repetitive Transcranial Magnetic Stimulation (rTMS)
DeviceThe 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)
DeviceThe 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.
Change in the Montgomery-Åsberg Depression Rating Scale (MADRS) from baseline to post-intervention period.
MADRS is a clinician-rated measure of depressive symptom severity with total scores ranging from 0 to 60, where higher scores indicate greater depression severity. Change in MADRS total score will be calculated from baseline (pre-treatment) to post-treatment.
Change in Patient Health Questionnaire-9 (PHQ-9) total score from baseline to post-intervention period follow up.
PHQ-9 is a patient-reported score that ranges from 0 to 27, where higher scores indicate greater depression severity. Change in PHQ-9 total score will be calculated from baseline (pre-treatment) to post-treatment.
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University of Pennsylvania
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
