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

Early Phase 1Not Yet RecruitingNCT06819358

Peking University Third Hospital45 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Amyotrophic Lateral Sclerosis (ALS)

Interventions

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).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Aged 18-80 years; 2. Diagnosis of motor neuron disease at probable level or above based on Estorial criteria;12 3. 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 4. Presence of lower limb dysfunction: Berg balance scale score below 40; 5. Capable of standing independently for more than 30 seconds and able to walk or walk with assistance; 6. Stable medication dosage for at least one month; 7. FVC \> 60%; 8. Signed informed consent. Exclusion Criteria: 1. History of substance abuse within the past 6 months; 2. History of epilepsy or first-degree relative with epilepsy; 3. Patients with severe systemic diseases in the heart, lungs, liver, or kidneys that cannot be controlled with routine medications, based on laboratory results; 4. Patients with severe depression or anxiety (HAMD-17 score ≥18; HAMA score ≥21) or diagnosed with other mental illnesses; 5. Patients with a life expectancy of less than one year due to reasons other than neurodegenerative diseases; 6. Pregnant women or those planning to become pregnant; 7. 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; 8. Patients who have received TMS, transcranial electrical stimulation, transcranial focused ultrasound, or other neuromodulation treatments within three months prior to enrollment; 9. Other abnormal examination results deemed unsuitable for participation by the research investigator; 10. Inability to cooperate for follow-ups due to geographical or other reasons; 11. Participation in other clinical research trials.

Outcomes

Primary Outcomes

Scale evaluation

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.