Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 12:05 AM
NCT ID:
NCT06819358
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06819358
Study Brief:
Protocol Section:
NCT06819358