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 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07452133
Eligibility Criteria:
Inclusion Criteria:
Healthy volunteers:
1. Adults aged 21 years or older with the mental capacity to provide informed consent.
2. No prior diagnosis of neuromuscular or neurological conditions affecting the lower limbs.
3. Able to walk independently with a normal gait pattern, as confirmed by clinical observation done by the study team.
SCI patients:
1. Age 21 -75 years;
2. Non-progressive, incomplete SCI (traumatic or non-traumatic).
3. International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) /ASIA Impairment scale (AIS) grade B, C, or D, with Lower Extremity Motor Scores (ISNCSCI-LEMS) less than or equal to 40;
4. Injury level at/above L1 (above conus medullaris) with intact segmental reflexes below level of lesion;
5. Able to provide informed consent;
6. No contraindication for tSCS, such as pace makers or other implantable electrical devices;
7. Eligible for body-weight support treadmill training;
8. Able to stand with body weight support and/or assistance.
Exclusion Criteria:
Healthy voluteers:
1. Presence of significant or unstable medical comorbidities, including uncontrolled cardiopulmonary disease or severe cognitive impairment, as determined by the study team.
2. Diagnosis of any neuromuscular or musculoskeletal disorders (e.g., congenital skeletal deformity, limb amputation, neurological disorders, myopathy).
3. Abnormal gait pattern due to underlying medical co-morbidities, as identified through physical examination and clinical assessment, and confirmed by the study team.
4. Current pregnancy.
SCI patients:
1. Significant or unstable medical co-morbidities, including uncontrolled cardiopulmonary disease, severe cognitive impairment, or severe dysautonomia, as determined by the study team;
2. Uncontrolled neuropathic or musculoskeletal pain, or contractures affecting participation in therapy;
3. Known history of peripheral nerve injury (e.g., traumatic nerve injury, entrapment neuropathy);
4. Pregnancy;
5. Active malignancy or ongoing cancer treatment;
6. Skin conditions (e.g., ulcers, infections, malignant lesions) that limit the application of tSCS electrodes;
7. Prior exposure to tSCS or eSCS interventions.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
75 Years
Study:
NCT07452133
Study Brief:
Protocol Section:
NCT07452133