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

NCT ID: NCT06819358

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-14
• Study Completion Date: 2026-03-15

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.

Conditions

Amyotrophic Lateral Sclerosis (ALS)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group A

Group Type: ACTIVE_COMPARATOR

Transcranial Magnetic Stimulation

Intervention Type: DEVICE

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).

Group B

Group Type: SHAM_COMPARATOR

Transcranial Magnetic Stimulation

Intervention Type: DEVICE

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).

Interventions

Transcranial Magnetic Stimulation

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).

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Changping Laboratory

OTHER

Sponsor Role: collaborator

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

He Ji

Associate professor/Associate chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Ji He

Role: CONTACT

15801224009@163.COM

+86 15801224009

Other Identifiers

M2024877

Identifier Type: -

Identifier Source: org_study_id