Home-Based Wearable rTMS Therapy for Moderate to Severe Depression
ConditionMajor Depressive Disorder
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorShanghai Mental Health Center
About this trial
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 .
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnostic and Severity Requirements Meet DSM-5 criteria for Major Depressive Disorder (MDD). Current moderate-to-severe depressive episode, defined by Hamilton Depression Rating Scale 17-item (HAMD-17) score ≥18 .
Pharmacological Stability Stable antidepressant regimen for ≥4 weeks prior to enrollment, restricted to SSRIs (Selective Serotonin Reuptake Inhibitors).
Technical Feasibility Medically eligible for both structural MRI and resting-state functional MRI (fMRI) examinations.
Disqualifiers
Psychiatric Comorbidities Any concurrent psychiatric diagnosis (e.g., autism spectrum disorder, severe cognitive impairment, epilepsy, mania, psychosis) .
Neurological Structural Abnormalities Structural brain lesions increasing seizure risk or disrupting neural connectivity (e.g., brain tumors, history of stroke).
Systemic Medical Conditions Unstable cardiovascular, respiratory, hepatic, renal diseases, or active malignancies.
Contraindications to Procedures TMS contraindications: Metallic implants, pacemakers, history of epilepsy. MRI contraindications: Ferromagnetic implants, claustrophobia requiring sedation.
Trial design
Design model
Parallel
Treatments tested in this trial
rTMS-Tiny Treatment
DeviceStimulation protocol using the rTMS-Tiny device with identical parameters to SNT: Stimulation mode Intermittent Theta-Burst Stimulation (iTBS) Burst composition: Each burst consists of 3 pulses at 50 Hz Train structure: 10 bursts repeated at 5 Hz per train (total train duration: 2 seconds) Inter-train interval: 8 seconds Session parameters Pulses per session: 1,800 pulses Session duration: 570 seconds (≈9.5 minutes) Inter-session interval: 50 minutes Daily frequency: 10 sessions per day Weekly schedule: 5 days per week Treatment course: 1 week (total 50 sessions) Total pulses per course: 1,800 pulses/session × 50 sessions = 90,000 pulses
Sham Stimulation
DeviceThe key difference lies in the use of a sham stimulation coil instead of the rTMS-Tiny active treatment coil.
Treatment groups
124 Participants
are divided into 2 treatment groupsGroup A: rTMS-Tiny Treatment GroupExperimental treatment 1 intervention
Group B: rTMS-Tiny Sham Stimulation GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change From Baseline in 17-item Hamilton Depression Rating Scale (HAMD-17) Total Score
Depressive symptom severity was assessed using the 17-item Hamilton Depression Rating Scale (HAMD-17; total score range, 0-52, with higher scores indicating more severe depression；Treatment Response Rate:≥50% reduction from baseline in HAMD-17 total score;Treatment Remission Rate:Post-treatment HAMD-17 Score \< 8)
Time frame
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)Secondary outcomes
1
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Depressive symptom severity assessed with the Montgomery-Asberg Depression Rating Scale (MADRS), a 10-item clinician-rated scale. The total score ranges from 0 (minimum) to 60 (maximum); higher scores indicate more severe depressive symptoms (worse outcome), and lower scores indicate improvement.
Time frame
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)Other outcomes
1
Change in Beck Depression Inventory-II (BDI-II) Total Score
Depressive symptom severity assessed with the Beck Depression Inventory-II (BDI-II), a 21-item self-report scale. The total score ranges from 0 (minimum) to 63 (maximum); higher scores indicate more severe depressive symptoms (worse outcome), and lower scores indicate improvement.
Time frame
During treT1 (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 fatment2
Change in Hamilton Anxiety Rating Scale (HAMA) Total Score
Anxiety symptom severity assessed with the Hamilton Anxiety Rating Scale (HAMA), a 14-item clinician-rated scale. The total score ranges from 0 (minimum) to 56 (maximum); higher scores indicate more severe anxiety symptoms (worse outcome), and lower scores indicate improvement.
Time frame
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)3
Change in Brief Symptom Inventory (BSI) Total Score
Overall psychological distress assessed with the Brief Symptom Inventory (BSI), a 53-item self-report scale (each item rated 0-4)，from 0 (minimum) to 212 (maximum). The Global Severity Index (GSI) ranges from 0 (minimum) to 4 (maximum); higher scores indicate greater psychological distress (worse outcome), and lower scores indicate improvement.
Time frame
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)4
Change in Insomnia Severity Index (ISI) Total Score
Insomnia severity assessed with the Insomnia Severity Index (ISI), a 7-item self-report scale. The total score ranges from 0 (minimum) to 28 (maximum); higher scores indicate more severe insomnia (worse outcome), and lower scores indicate improvement.
Time frame
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Shanghai Mental Health Center
Lead sponsor
Ministry of Science and Technology of the People´s Republic of China
Collaborator
Peking University Sixth Hospital
Collaborator
The Central Hospital of Yongzhou
Collaborator
Source ClinicalTrials.gov
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