MRI-guided rTMS for adolescents with major depression
Efficacy and Safety of Magnetic Resonance Imaging-guided Repetitive Transcranial Magnetic Stimulation (rTMS) in Adolescents With Depression: A Randomized, Double-Blind, Controlled Pilot Study
This trial will test whether MRI-guided repetitive transcranial magnetic stimulation (rTMS) can reduce depressive symptoms in adolescents aged 12–18 compared with standard rTMS or sham treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 12 Years to 18 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital of Chongqing Medical University Academic / other |
| Locations | 1 site (Chongqing) |
| Trial ID | NCT07185438 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind, controlled pilot assigns adolescents with DSM-5 major depressive disorder to one of three groups: MRI-guided experimental-target rTMS, conventional left DLPFC rTMS, or sham stimulation in a 1:1:1 ratio. All participants receive 20 weekday sessions over 4 weeks of 10 Hz stimulation at 120% resting motor threshold using a Blackdolphin TMS robot, with the experimental group targeting the voxel in the left DLPFC most negatively correlated with subgenual ACC connectivity. The trial measures feasibility, safety, acceptability, and preliminary trends in efficacy to inform the design of larger randomized trials. Participants must complete MRI scans and attend daily in-person stimulation sessions.
Who should consider this trial
Good fit: Ideal participants are adolescents aged 12–18 with a current DSM-5 major depressive episode, CDRS-R score ≥40, and at least four weeks of stable psychiatric medication without significant neurological or severe medical comorbidities.
Not a fit: Patients with psychotic symptoms, high mania scores, epilepsy or other neurological disorders, current anticonvulsant or high‑dose benzodiazepine use, severe medical illness, or those outside the 12–18 age range are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the approach could offer a non-drug option that more precisely targets brain circuits and reduces depressive symptoms in adolescents.
How similar studies have performed: rTMS has established efficacy in adults and limited pilot data in adolescents suggest potential benefit, while MRI-guided individualized targeting is a relatively novel approach with promising but unproven pediatric evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 12 - 18 2. Diagnosis of major depressive disorder (MDD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed through the Kiddie Schedule for Affective Disorders and Schizophrenia - Present and Lifetime version (K-SADS-PL), currently in a depressive episode 3. Score≥40 on the CDRS-R 4. Stable pharmacological treatment: At least 4 weeks of stable psychiatric medication use prior to enrollment, with continuation of the same psychiatric medication regimen throughout the study. Exclusion Criteria: 1. Psychiatric comorbidities other than anxiety disorders 2. Depression with psychotic symptoms 3. Young Mania Rating Scale (YMRS) score \>13 4. A history of neurological disorders (e.g., epilepsy, brain injury) or severe somatic diseases (e.g., thyroid disorders, lupus, diabetes, pulmonary, hepatic, or renal impairment, major trauma) 5. Patients currently using anticonvulsants or high-dose benzodiazepines 6. A history of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), or other neuromodulation treatments 7. A history of alcohol or substance abuse or dependence 8. Women who are pregnant or breastfeeding 9. Current high suicide risk 10. Potential complicating factors related to transcranial magnetic stimulation, such as scalp conditions or perforations that may affect magnetic field delivery 11. Contraindications to MRI
Where this trial is running
Chongqing
- The First Affiliated Hospital of Chongqing Medical University — Chongqing, China (Recruiting)
Study contacts
- Study coordinator: Xinyu Zhou
- Email: zhouxinyu@cqmu.edu.cn
- Phone: 15823996993
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.