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:
2025-12-24 @ 12:06 PM
Ignite Modification Date:
2025-12-24 @ 12:06 PM
NCT ID:
NCT04391361
Eligibility Criteria:
Inclusion Criteria:
1. Patients should voluntarily participate in the experiment by signing an informed consent form.
2. Patients should comply with the research process and cooperate with the interventions applied throughout the experiment.
3. Patients should be between 30 and 65 years of age, and both sexes are acceptable.
4. Patients should comply with the diagnostic criteria and exclusion criteria for amyotrophic lateral sclerosis in the Chinese Guidelines for the Diagnosis and Treatment of Amyotrophic Lateral Sclerosis developed by the Chinese Society of Neurology of the Chinese Medical Association in 2012.
5. Patient's amyotrophic lateral sclerosis history must not exceed 5 years.
6. ALS functional scale score (ALSFRS-R) should be ≥ 2 points for each patients.
Exclusion Criteria:
1. Patients with cardiac conduction block, severe ventricular insufficiency, severe hepatorenal insufficiency and severe, progressive or uncontrolled major organ and systemic disease.
2. High or low blood pressure: systolic blood pressure \>150 or \<110 mmHg; bradycardia (\<60 beats per minute).
3. Patients with ventilator-assisted ventilation.
4. Patients who are allergic to research intervention drugs.
5. Patients with obvious signs of dementia.
6. Female patients who are pregnant or breastfeeding or who have a plan to become pregnant in the near future.
7. Persons with other psychiatric disorders that may affect the assessment of their condition.
8. Severely obese patients (BMI \>35kg/m2).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
65 Years
Study:
NCT04391361
Study Brief:
Protocol Section:
NCT04391361