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Sham Stimulation / Major Depressive Disorder / rTMS-Tiny Treatment · Interventional Study
ClinicalTrials.gov · August 20, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a planned multicenter randomized controlled trial of a novel wearable repetitive transcranial magnetic stimulation device (rTMS-Tiny) for moderate to severe major depressive disorder, comparing active treatment to sham stimulation. The study has not yet begun recruitment and no efficacy or safety results are available.
Interventional, Randomized, Parallel, Double masking, Treatment purpose. Major Depressive Disorder; age from 18 Years; to 65 Years. Intervention: rTMS-Tiny Treatment Group. Compared with: rTMS-Tiny Sham Stimulation Group — Placebo Comparator. n = 124. 1 site: China.
This is a planned multicenter randomized controlled trial of a novel wearable repetitive transcranial magnetic stimulation device (rTMS-Tiny) for moderate to severe major depressive disorder, comparing active treatment to sham stimulation. The study has not yet begun recruitment and no efficacy or safety results are available.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
Once results become available, this trial may inform whether wearable, home-based rTMS is efficacious and safe for depression treatment and whether it can enable intensive protocols like SAINT outside clinical settings. Clinicians should monitor for publication once recruitment and follow-up are complete.
This is a trial registration with no results posted; the study is not yet recruiting and represents planned work to test a novel wearable rTMS device.
As stated by the source record.
Quoted from the source exactly as published.
Once results become available, this trial may inform whether wearable, home-based rTMS is efficacious and safe for depression treatment and whether it can enable intensive protocols like SAINT outside clinical settings. Clinicians should monitor for publication once recruitment and follow-up are complete.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07775586). This is a study registration, not published results. Lead sponsor: Shanghai Mental Health Center. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 124 participants (ESTIMATED). Conditions: Major Depressive Disorder. Interventions: DEVICE: rTMS-Tiny Treatment; DEVICE: Sham Stimulation. Primary outcome measures: Change From Baseline in 17-item Hamilton Depression Rating Scale (HAMD-17) Total Score , T1 (Baseline )Day 0, prior to the first rTMS session; T2 (Mid-peri-procedural period (~Month 6 ±2 weeks）)； T3 ( End of peri-procedural period (within 1 week of last session) )； T4 (4-week follow-up)； T5 (3-month follow-up)； T6 (6-month follow-up). Brief summary: Background and Rationale With rapid economic development and increasing societal pressures, the incidence of neuropsychiatric disorders has risen annually, ranking as the leading cause of disability worldwide and imposing a severe societal burden. Among these, depressive disorders represent a primary contributor. However, the efficacy and accessibility of transcranial magnetic stimulation (TMS) for depression face significant challenges. Key limitations include: Low targeting accuracy with traditional localization methods. Limited clinical penetration of individualized precision paradigms . In this context, wearable repetitive TMS (wrTMS) technology offers a transformative solution. The rTMS-Tiny device, developed by the Institute of Automation, Chinese Academy of Sciences, exemplifies this innovation with the following features: Battery-powered with a pulse capacity exceeding 8,000 pulses per charge. Ultra-lightweight design: Total system weight \<3 kg, coil helmet \<2 kg (10% of conventional devices). Performance parity: Comparable efficacy to standard rTMS systems while enabling protocols like Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT) . Advantages of rTMS-Tiny Portable Design and Wearable Application Ergonomically optimized helmet allows near-unrestricted daily activities during treatment . Streamlined Operational Workflow Simplified protocols significantly reduce clinician workload . Enhanced Treatment Tolerability Improved comfort increases treatment completion rates and long-term adherence, directly enhancing therapeutic outcomes . These advantages enable high-dose, intensive regimens (e.g., SAINT-like protocols) in routine clinical practice . Scientific Imperative for a Multicenter RCT A multicenter randomized controlled trial (RCT) of rTMS-Tiny is clinically and scientifically warranted to: Test two core hypotheses: Hypothesis 1: Efficacy of rTMS-Tiny in reducing depressive symptoms. Hypothesis 2: Safety of home-based rTMS-Tiny administration . Generate high-level evidence to advance neuromodulation into an era of precision, personalization, and artificial intelligence-driven therapy .
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