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

NCT06819358 | Not Yet Recruiting Early Phase 1

• 1 other identifier: M2024877
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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)

Keywords

Individualized cortical mapping technology, repetitive transcranial magnetic stimulation, amyotrophic lateral sclerosis, balance and gait disorders.

Outcome Measures

Primary Outcomes (1)

• Scale evaluation

  The Berg Balance Scale (BBS) assesses static and dynamic balance. The scale ranges from 0 to 56, with higher scores indicating better balance and lower scores signifying greater fall risk.

  Baseline (Week 0), Week 2, Week 6, Week 8

Secondary Outcomes (7)

• Scale evaluation

  Baseline (Week 0), Week 2, Week 6, Week 8

• Scale evaluation

  Baseline (Week 0), Week 2, Week 6, Week 8

• Scale evaluation

  Baseline (Week 0), Week 2, Week 6, Week 8

• Scale evaluation

  Baseline (Week 0), Week 2, Week 6, Week 8

• Imaging evaluation

  Baseline (Week 0), Week 2, Week 6, Week 8

Study Arms (2)

Group A

ACTIVE COMPARATOR

Device: Transcranial Magnetic Stimulation

Group B

SHAM COMPARATOR

Device: Transcranial Magnetic Stimulation

Interventions

Transcranial Magnetic Stimulation 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 A; Group B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• FVC \> 60%;
• Signed informed consent.

You may not qualify if:

• 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;
• 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;
• Patients who have received TMS, transcranial electrical stimulation, transcranial focused ultrasound, or other neuromodulation treatments within three months prior to enrollment;
• Other abnormal examination results deemed unsuitable for participation by the research investigator;
• Inability to cooperate for follow-ups due to geographical or other reasons;
• Participation in other clinical research trials.

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Changping Laboratory: collaborator

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Mobility Limitation

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Central Study Contacts

Ji He

CONTACT

+86 15801224009; 15801224009@163.COM

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor/Associate chief physician

Model Details: 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.

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: February 11, 2025
• Study Start: February 14, 2025
• Primary Completion: March 15, 2026
• Study Completion: March 15, 2026
• Last Updated: February 11, 2025

Record last verified: 2025-02