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

Trial ID: NCT06819358

Interventional - Phase 1 - Not yet recruiting

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.

Conditions

• Amyotrophic Lateral Sclerosis (ALS)

Interventions

• Transcranial Magnetic Stimulation

Eligibility

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.

Sponsor

Peking University Third Hospital, Changping Laboratory

Source: ClinicalTrials.gov

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