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 @ 2:39 AM
Ignite Modification Date:
2025-12-25 @ 2:39 AM
NCT ID:
NCT06944834
Eligibility Criteria:
Inclusion Criteria:
* Adults aged 18-65 years;
* Patients with complete or incomplete quadriplegia due to spinal cord injury, brainstem stroke, amyotrophic lateral sclerosis (ALS), or other motor neuron diseases, or those with bilateral upper limb amputations;
* Normal motor cortex function confirmed by neurological assessment;
* Muscle strength of bilateral or unilateral upper limbs ≤ Grade 3;
* Patients who have received standardized treatment and met diagnostic criteria for at least 12 months before screening, with stable disease status for ≥6 months;
* Expected lifespan ≥12 months;
* Normal cognitive function;
* Normal hearing and vision, or corrected vision to normal with standard lenses;
* Patients with stable caregivers;
* Willing to sign informed consent and able to comply with follow-up requirements.
Exclusion Criteria:
* Patients with neuropsychiatric disorders or psychological impairments;
* Patients with brain MRI findings showing hemorrhage, tumors, anatomical abnormalities, or distortions;
* History of severe systemic diseases (e.g., cardiac, pulmonary, hepatic, renal, thyroid, gastrointestinal, or hematologic disorders), poorly controlled diabetes, or pregnancy in females;
* History of infectious diseases (e.g., syphilis, HIV), severe traumatic brain injury, or major surgeries;
* Presence of metal implants or devices (e.g., cochlear implants, pacemakers, neurostimulators, defibrillators), except for dental implants or other implants deemed non-interfering;
* Surgical or anesthesia contraindications as determined by surgeons or anesthesiologists;
* Morbid obesity (BMI \>40);
* Hearing impairment or uncorrectable visual deficits that would hinder prolonged computer monitor viewing;
* Current participation in other clinical trials;
* Other conditions considered unsuitable by investigators or medical staff.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06944834
Study Brief:
Protocol Section:
NCT06944834