NCT06819358
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
Not Yet Recruiting · Early Phase 1 · Peking University Third Hospital · registry updated 2025-02-11
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- 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;
Exclusion
- 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;