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 @ 6:38 PM
Ignite Modification Date:
2025-12-24 @ 6:38 PM
NCT ID:
NCT03886857
Eligibility Criteria:
Inclusion Criteria:
written informed consent prior to participation
for participants with intact CNS:
• no previous neurological or musculoskeletal disorders
for participants with spinal cord injury:
* Spinal cord injury due to trauma
* ≥ 12 months post-spinal cord injury
* complete or incomplete spinal cord injury classified as grade C or D on the American Spinal Injury Association Impairment Scale (AIS)
* neurological level of spinal cord injury: C3-T10
* preserved tendon and cutaneo-muscular reflexes in the lower limbs
Exclusion Criteria:
* other neuromuscular diseases, e.g., amyotrophic lateral sclerosis (ALS), Parkinson's disease, Guillain-Barré syndrome, muscular dystrophy
* active implants (e.g., cardiac pacemaker, drug pump)
* passive implants at vertebral level T10 or caudal (e.g., metal screws/plates for surgical stabilization of spinal fractures)
* active infections or diseases, pressure sores
* dermatological issues at the stimulation site
* malignant diseases
* heart insufficiency (NYHA III-IV)
* potential pregnancy (pregnancy test to be conducted in women of child bearing age before application of transcutaneous spinal cord stimulation)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03886857
Study Brief:
Protocol Section:
NCT03886857