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Not yet recruiting 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

Early Phase I Interventional Amyotrophic Lateral Sclerosis (ALS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcranial Magnetic Stimulation.
Who it may be relevant to
Registry conditions: Amyotrophic Lateral Sclerosis (ALS). Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device 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).

Primary outcome measures

  • Scale evaluation [Time frame: Baseline (Week 0), Week 2, Week 6, Week 8]
Secondary outcome measures (7)
  • Scale evaluation [Time frame: Baseline (Week 0), Week 2, Week 6, Week 8]
  • Scale evaluation [Time frame: Baseline (Week 0), Week 2, Week 6, Week 8]
  • Scale evaluation [Time frame: Baseline (Week 0), Week 2, Week 6, Week 8]
  • Scale evaluation [Time frame: Baseline (Week 0), Week 2, Week 6, Week 8]
  • Imaging evaluation [Time frame: Baseline (Week 0), Week 2, Week 6, Week 8]
  • Gait instrument [Time frame: Baseline (Week 0), Week 2, Week 6, Week 8]
  • biological indicator [Time frame: Baseline (Week 0), Week 2, Week 6, Week 8]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06819358 · M2024877

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗