Clinical trial 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
Official title: 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 type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Amyotrophic Lateral Sclerosis (ALS)
Keywords: Individualized cortical mapping technology, repetitive transcranial magnetic stimulation, amyotrophic lateral sclerosis, balance and gait disorders.
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: Changping Laboratory
First posted: 2025-02-11
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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 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.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Scale evaluation
timeFrame: Baseline (Week 0), Week 2, Week 6, Week 8
Secondary outcomes:
measure: Scale evaluation
timeFrame: Baseline (Week 0), Week 2, Week 6, Week 8
measure: Scale evaluation
timeFrame: Baseline (Week 0), Week 2, Week 6, Week 8
measure: Scale evaluation
timeFrame: Baseline (Week 0), Week 2, Week 6, Week 8
measure: Scale evaluation
timeFrame: Baseline (Week 0), Week 2, Week 6, Week 8
measure: Imaging evaluation
timeFrame: Baseline (Week 0), Week 2, Week 6, Week 8
measure: Gait instrument
timeFrame: Baseline (Week 0), Week 2, Week 6, Week 8
measure: biological indicator
timeFrame: Baseline (Week 0), Week 2, Week 6, Week 8
Other outcomes:
Locations:
Study officials:
References: