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 @ 4:08 PM
Ignite Modification Date:
2025-12-24 @ 4:08 PM
NCT ID:
NCT02799966
Eligibility Criteria:
Inclusion Criteria:
1. Traumatic incomplete (AIS B-D) C4-C7 SCI
2. Early treatment group = 10 days to 6 months (182 days) post tSCI (note it is expected that most ppts will be recruited from this group, while at GF Strong)
3. Late treatment group = initiate treatment on or after 6 months plus one day (183 days+) post tSCI
4. SCIM self-care sub-score ≤ 10
5. Able to understand and follow instructions
6. Able to be in a seated position for a least one hour of upper limb therapy
7. Able to attend the study treatment sessions
8. Able to provide informed consent
9. Men and women of the age of majority in their province or state
Exclusion Criteria:
1. Previous history of any other neurological disorder or conditions that may affect motor response
2. Upper extremity injury or condition prior to SCI that limits the function of the hand or arm
3. Malignant skin lesion on the affected upper extremity
4. History of seizure disorder not effectively managed by seizure medications
5. An existing electrical stimulation devices (e.g. ICD, Pacemaker, Spinal Stimulation)
6. Rash or open wound at any potential electrode site
7. Denervation of muscles that are targeted by MyndMove
8. Poorly controlled autonomic dysreflexia (as determined by the local site physician)
9. In the judgment of the local site physician, participant has medical complications that may interfere with the execution of the study
10. Botulinum toxin injection into affected upper extremity within 3 months prior to the study start. No botulinum toxin injections during the study treatment and follow up period.
11. Currently enrolled in another upper limb study
12. Enrolled, in the past six months, in a clinical study involving drugs or biologics
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02799966
Study Brief:
Protocol Section:
NCT02799966