Individualized Functional Imaging-Guided Repetitive Transcranial Magnetic Stimulation (rTMS) for Treating Postural Gait Disorders in Patients with Amyotrophic Lateral Sclerosis (ALS): a Randomized, Crossover, Controlled, Double-Blind Clinical Study
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 45
- 主要终点
- Scale evaluation
研究概览
简要总结
This study is a randomized, crossover, controlled, double-blind clinical trial. Patients (n=45) were randomly divided into Group A and Group B. Patients in Group A will receive 2 weeks (10800 Hz daily, 5 days×2) of Transcranial magnetic stimulation（TMS） treatment, while patients in Group B will receive sham stimulation with the same frequency. After a 4-week washout period, the two groups cross over. Patients in Group A will receive sham stimulation, and patients in Group B will receive TMS treatment for 2 weeks (10800 Hz daily, 5 days×2). Clinical functional scales, imaging evaluations, and gait analysis will be conducted at baseline, after 2 weeks of treatment, before crossover treatment, and after 2 weeks of crossover treatment. The therapist, patients, and assessors will be all blinded throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-80 years;
- •Diagnosis of motor neuron disease at probable level or above based on Estorial criteria;12
- •Meet UMND ALS diagnosis criteria: at least three segments of upper motor neuron damage localized to 1-2 muscles, or EMG indicating loss of innervation in 1-2 muscles;13
- •Presence of lower limb dysfunction: Berg balance scale score below 40;
- •Capable of standing independently for more than 30 seconds and able to walk or walk with assistance;
- •Stable medication dosage for at least one month;
- •FVC > 60%;
- •Signed informed consent.
排除标准
- •History of substance abuse within the past 6 months;
- •History of epilepsy or first-degree relative with epilepsy;
- •Patients with severe systemic diseases in the heart, lungs, liver, or kidneys that cannot be controlled with routine medications, based on laboratory results;
- •Patients with severe depression or anxiety (HAMD-17 score ≥18; HAMA score ≥21) or diagnosed with other mental illnesses;
- •Patients with a life expectancy of less than one year due to reasons other than neurodegenerative diseases;
- •Pregnant women or those planning to become pregnant;
- •Individuals with a pacemaker, cochlear implant, or other metallic foreign bodies and any implanted electronic equipment, or those with contraindications for MRI scanning or TMS treatment, such as claustrophobia;
- •Patients who have received TMS, transcranial electrical stimulation, transcranial focused ultrasound, or other neuromodulation treatments within three months prior to enrollment;
- •Other abnormal examination results deemed unsuitable for participation by the research investigator;
- •Inability to cooperate for follow-ups due to geographical or other reasons;
- •Participation in other clinical research trials.
研究组 & 干预措施
Group A
干预措施: Transcranial Magnetic Stimulation (Device)
Group B
干预措施: Transcranial Magnetic Stimulation (Device)
结局指标
主要结局
Scale evaluation
时间窗: Baseline (Week 0), Week 2, Week 6, Week 8
The Berg Balance Scale (BBS) assesses static and dynamic balance. The scale ranges from 0 to 56, with higher scores indicating better balance and lower scores signifying greater fall risk.
次要结局
- Scale evaluation(Baseline (Week 0), Week 2, Week 6, Week 8)
- Imaging evaluation(Baseline (Week 0), Week 2, Week 6, Week 8)
- Gait instrument(Baseline (Week 0), Week 2, Week 6, Week 8)
- biological indicator(Baseline (Week 0), Week 2, Week 6, Week 8)
研究者
He Ji
Associate professor/Associate chief physician
Peking University Third Hospital