Multicenter Randomized Controlled Trial Assessing Wearable Repetitive Transcranial Magnetic Stimulation for Home-Based Treatment of Depression
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Change From Baseline in 17-item Hamilton Depression Rating Scale (HAMD-17) Total Score
研究概览
简要总结
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 .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Inclusion Criteria
- •Demographics Aged 18-65 years, any gender. Minimum education: primary school completion (≥6 years of formal education).
- •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).
- •Treatment-naïve patients permitted if no psychotropic medications used within the prior 4 weeks.
- •Mandatory maintenance of the same regimen throughout the study and post-treatment follow-up.
- •Technical Feasibility Medically eligible for both structural MRI and resting-state functional MRI (fMRI) examinations.
排除标准
- •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.
- •Recent Neuromodulation Therapies Prior ECT (Electroconvulsive Therapy) or rTMS (repetitive Transcranial Magnetic Stimulation) within 3 months.
- •History of neurosurgical interventions for depression (e.g., deep brain stimulation).
- •6）Special Populations Pregnancy, lactation, or planning pregnancy during the study. 7）Medication Instability Planned adjustments to pharmacotherapy during the study period.
- •Withdrawal and Discontinuation Criteria
- •Participant-Initiated Withdrawal Voluntary withdrawal: Participant withdraws consent (e.g., refusal to risk assignment to sham stimulation group).
- •Investigator-Initiated Withdrawal Non-compliance with inclusion criteria: Post-randomization discovery of ineligibility (e.g., symptom remission, medication non-adherence).
- •Serious Adverse Events (SAEs):
- •TMS-related SAEs (e.g., seizure, intractable headache, exacerbated suicidality).
- •Study Discontinuation
- •Prespecified Efficacy Stoppage:
- •Interim analysis at n=30/group showing superiority of active intervention (Cohen's d >0.8) .
- •Safety-Driven Discontinuation:
- •Unacceptable risk profile (e.g., recurrent SAEs such as seizures or suicidality).
- •Loss to Follow-Up:
- •Trial termination if attrition rate exceeds pre-specified thresholds compromising statistical power (e.g., >20% dropout).
结局指标
主要结局
Change From Baseline in 17-item Hamilton Depression Rating Scale (HAMD-17) Total Score
时间窗: 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)
次要结局
- Change in Montgomery-Asberg Depression Rating Scale (MADRS) 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))