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 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT02313194
Eligibility Criteria:
Inclusion Criteria:
1. Stable medical condition without cardiopulmonary disease or dysautonomia that would contraindicate hand/arm movement
2. No severe cardiopulmonary diseases such as severe bradycardia, severe autonomic dysreflexia, and/or Chronic Obstructive Pulmonary Disease.
3. No painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore, or infection that might interfere with upper extremity training
4. No clinically significant depression or ongoing drug abuse
5. No current anti-spasticity medication regimen
6. Non-progressive SCI above C5
7. Must not have received botox injections in the prior six months
8. Be unable to grip or move independently
9. Be at least one-year post injury
10. Must be at least 18 years of age
11. Segmental reflexes remain functional below the lesion
12. Female subjects of child-bearing potential must not be pregnant and must be using a medically acceptable method of contraception
13. No current implant(s) of neurostimulators, cardiac pacemakers, defibrillators, shunts, stents, or aneurysm clips, and must have no future exposure to diathermy following implantation
14. No coagulopathy, cardiac risk factors, or other significant medical risk factors for surgery
15. Must not be involved in another clinical trial
16. Must not have disorders or conditions that would require MRI monitoring
Exclusion Criteria:
None as long as inclusion criteria are met.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02313194
Study Brief:
Protocol Section:
NCT02313194