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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.

Last updated: Aug 11, 2026•1 RCTs•📖 Read as article →

Evidence Score

Evidence Score42/100
Human RCT★★☆☆☆
Meta-analysis☆☆☆☆☆
Mechanism★★★★★
Safety★★★★☆
Confidencelow

Study Evidence

Study 1. 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.

rct

Chen H, Xu D, Wang W, Luo X, Jiang X, Wan N, Wei Y, Wang T, Zhang L, Li X, Zhou X · PloS one (2026)

Participants: 45
Duration: 4 weeks treatment, 6-month follow-up
Intervention: rs-fcMRI-guided rTMS targeting the individualized DLPFC site with strongest negative connectivity to sgACC, compared to conventional left DLPFC rTMS and sham stimulation
Outcome: Feasibility (enrollment, completion of 20 sessions, 6-month retention), preliminary clinical efficacy (CDRS-R response and remission), safety (adverse events), secondary outcomes (depressive/anxiety symptoms, suicidality, sleep quality, global status, rumination, quality of life)
Effect Size: N/A
Population: Adolescents (ages not specified) with major depressive disorder (MDD)

Result: 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.

PubMed: 42561002DOI: 10.1371/journal.pone.0355676

Mechanism Graph

rs-fcMRI identifies DLPFC site with strongest negative functional connectivity to sgACC
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Targeted rTMS modulates this circuit
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Modulation of sgACC-DLPFC connectivity may alleviate depressive symptoms
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Result: Preliminary clinical efficacy and feasibility in adolescents

Limitations

  • ⚠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).

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References

  1. 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
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