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

Обзор

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.

Вмешательства

• Устройство Transcranial Magnetic Stimulation
  Patients in Group A will receive 2 weeks (10800 Hz daily, 5 days×2) of 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).

Первичные конечные точки

• Scale evaluation [Срок оценки: Baseline (Week 0), Week 2, Week 6, Week 8]

Вторичные конечные точки (7)

• Scale evaluation [Срок оценки: Baseline (Week 0), Week 2, Week 6, Week 8]
• Scale evaluation [Срок оценки: Baseline (Week 0), Week 2, Week 6, Week 8]
• Scale evaluation [Срок оценки: Baseline (Week 0), Week 2, Week 6, Week 8]
• Scale evaluation [Срок оценки: Baseline (Week 0), Week 2, Week 6, Week 8]
• Imaging evaluation [Срок оценки: Baseline (Week 0), Week 2, Week 6, Week 8]
• Gait instrument [Срок оценки: Baseline (Week 0), Week 2, Week 6, Week 8]
• biological indicator [Срок оценки: Baseline (Week 0), Week 2, Week 6, Week 8]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06819358 · M2024877

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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