Home-Based Wearable rTMS Therapy for Moderate to Severe Depression

Condition(s) studied

Investigational drug(s) / intervention(s)

rTMS-Tiny Treatment: Stimulation 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: The key difference lies in the use of a sham stimulation coil instead of the rTMS-Tiny active treatment coil.

Study 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 .

Eligibility

Primary outcome measure(s)

• 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)
  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)

Trial sites (1)

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