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 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT04083794
Eligibility Criteria:
Inclusion Criteria:
* healthy males and females
* individuals with spinal cord injuries, between 3 and 24 months post injury, with complete injuries according to the American Spinal Injury Association Impairment Scale A and B, with injuries at T6 and below
Exclusion Criteria:
* clinical signs or symptoms of heart disease
* hypertension
* coronary disease
* diabetes
* other neurological disease
* cancer
* recent weight change \>15 pounds
* abnormal resting ECG
* pregnant and/or breastfeeding women
* underweight and obese individuals (body mass index between 18.5 and 29.9)
* use of amphetamines (Ritalin, Adderall, Concerta) in the past 48 hours
* tibial fracture or tibial stress fracture in the past year
* those with SCI will have no extreme spasticity to avoid spontaneous contractions
* use of baclofen for those with SCI
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT04083794
Study Brief:
Protocol Section:
NCT04083794