Clinical Trial

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

Study acronym: iFIRST-ALS

Not Yet Recruiting Early Phase 1

Record status

This record was last updated February 11, 2025 (before its estimated March 15, 2026 completion). Its status may not reflect the trial's current state.

Summary

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.

Trial Details

NCT Number	NCT06819358
Lead Sponsor	Peking University Third Hospital Collaborators: Changping Laboratory
Conditions	Amyotrophic Lateral Sclerosis (ALS)
Enrollment	45 participants
Start Date	2025-02-14
Primary Completion	2026-03-15 (estimated)
Study Completion	2026-03-15 (estimated)
Updated on ClinicalTrials.gov	2025-02-11