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:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07397559
Eligibility Criteria:
Inclusion Criteria:
1. Age between 16 and 65 years.
2. Have a spinal cord injury (neurological level C3-T12) that occurred ≥1 year (chronic stage) prior to enrollment.
3. American Spinal Injury Association (ASIA) Impairment Scale (AIS) classification C or D
4. Able to voluntarily contract (motor score ≥ 1) at least two leg muscles (visual or palpable contraction).
5. Use of prescription medication(s) for control of spasticity has not changed in the last 2 weeks
6. Able to provide consent
7. Ability to follow multiple instructions and communicate pain or discomfort
Exclusion Criteria:
1. Progressive spinal lesions, including degenerative disorders of the spinal cord
2. Pregnant, planning to become pregnant, or currently breastfeeding
3. History of cardiopulmonary disease or cardiac symptoms
4. Implanted stimulators of any type (baclofen pump, epidural spinal stimulator, cardiac defibrillator, pace-maker, etc.)
5. Presence of orthopedic conditions that would negatively affect participation in leg exercise
6. History of autonomic dysreflexia that is severe, unstable, and/or uncontrolled
7. Unstable or significant medical conditions that can interfere with exercise or neurophysiological evaluations, such as severe neuropathic pain, depression, mood disorders, or other cognitive disorders
8. Spasms that limit the ability to participate in leg exercise activity
9. Breakdown in skin area that will be in contact with electrodes
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
65 Years
Study:
NCT07397559
Study Brief:
Protocol Section:
NCT07397559