rs-fcMRI-guided rTMS is feasible and safe in adolescents with MDD, with preliminary clinical efficacy signals
This pilot trial will randomize 45 adolescents with MDD to conventional left DLPFC rTMS, rs-fcMRI-guided rTMS, or sham stimulation over 4 weeks. Primary outcomes include feasibility, adherence, retention, preliminary efficacy (CDRS-R response/remission), and safety. The study aims to provide preliminary evidence on feasibility and early efficacy of individualized circuit-informed rTMS.
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Rs-fcMRI-guided rTMS is feasible and safe in adolescents with MDD, with preliminary clinical efficacy signals The current body of evidence comprises 1 study, including 1 randomized controlled trial. EvidenceHub rates the overall confidence at 42/100 (low).
The Claim
rs-fcMRI-guided rTMS is feasible and safe in adolescents with MDD, with preliminary clinical efficacy signals
This conclusion is most relevant to: Adolescents (ages not specified) with major depressive disorder (MDD).
What the Research Shows
The conclusion draws on 1 linked study. Highlights from the cited literature:
- ▸Feasibility, safety, and preliminary clinical efficacy of resting-state functional connectivity MRI-guided rTMS for adolescents with major depressive disorder: Protocol for a randomized, double-blind, three-arm, sham-controlled pilot trial. (PloS one, 2026) — This pilot trial will randomize 45 adolescents with MDD to conventional left DLPFC rTMS, rs-fcMRI-guided rTMS, or sham stimulation over 4 weeks. Primary outcomes include feasibility, adherence, retention, preliminary efficacy (CDRS-R response/remission), and safety. The study aims to provide preliminary evidence on feasibility and early efficacy of individualized circuit-informed rTMS.
How It Works
The proposed biological pathway:
- ▸rs-fcMRI identifies DLPFC site with strongest negative functional connectivity to sgACC
- ▸Targeted rTMS modulates this circuit
- ▸Modulation of sgACC-DLPFC connectivity may alleviate depressive symptoms
- ▸Result: Preliminary clinical efficacy and feasibility in adolescents
Who Might Benefit
Evidence fit by population:
- ▸Adolescents (ages not specified) with major depressive disorder (MDD)
Recommended Dose
20 sessions of rTMS over 4 weeks (frequency and intensity not specified in abstract)
Limitations & Caveats
Important context when interpreting this evidence:
- ▸Pilot trial with small sample size (n=45), not powered for definitive efficacy
- ▸Abstract does not report actual results; only protocol description
- ▸Potential lack of blinding effectiveness due to different targeting procedures
Frequently Asked Questions
What is the primary goal of this trial?▼
To assess feasibility, safety, and preliminary clinical efficacy of rs-fcMRI-guided rTMS compared to conventional rTMS and sham in adolescents with MDD.
How many participants are included?▼
45 adolescents with MDD, randomized 1:1:1 to three arms.
What is the treatment duration?▼
4 weeks of rTMS, with 20 sessions, and 6-month follow-up.
What are the main outcome measures?▼
Feasibility (enrollment, adherence, retention), clinical response/remission on CDRS-R, and safety (adverse events).
References
- 1.Chen H, Xu D, Wang W, Luo X, Jiang X, Wan N, Wei Y, Wang T, Zhang L, Li X, Zhou X. “Feasibility, safety, and preliminary clinical efficacy of resting-state functional connectivity MRI-guided rTMS for adolescents with major depressive disorder: Protocol for a randomized, double-blind, three-arm, sham-controlled pilot trial..” PloS one, 2026. PMID: 42561002 DOI: 10.1371/journal.pone.0355676