NCT06819358Not yet recruitingEarly phase 1
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
Source: ClinicalTrials.gov · Last updated 11 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- First submitted
- 23 Jan 2025
- Start date
- 14 Feb 2025
- Primary completion date
- 15 Mar 2026
- Lead sponsor
- Peking University Third Hospital
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT06819358
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 45
- From 14 Feb 2025 to the primary completion date, 15 Mar 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 illness
- History of substance abuse within the past 6 months;
- History of epilepsy or first-degree relative with epilepsy;
- 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;
Lab values
- Patients with severe systemic diseases in the heart, lungs, liver, or kidneys that cannot be controlled with routine medications, based on laboratory results;
Other
- Pregnant women or those planning to become pregnant;
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.