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 @ 12:07 PM
Ignite Modification Date:
2025-12-24 @ 12:07 PM
NCT ID:
NCT03721861
Eligibility Criteria:
Inclusion Criteria:
1. Neurological level ≥ C7
2. 18 years old min and max 65 years old,
3. Complete traumatic injury: defined by A or B score on the AIS scale.
4. patient belonging to group 0 or 1 of the Giens classification.
5. neurological stability (no change in muscle testing)\> 6 months,
6. post-injury duration\> 6 months
7. Patients undergoing surgery to restore elbow extension.
8. threshold of stimulation and diffusion of the studied muscles below 50 mA of intensity for a pulse width of 300 μs and a frequency of 25 Hz.
9. positive electrical mapping of muscles with a minimum score of 4 MRC for at least one of the extensors (triceps, ECRL, ECRB, EDC, EPL) and / or flexor (FPL, FDS, FDP).
Exclusion Criteria:
* 1\. strong spasticity and contractures in flexion or extension of the upper limbs.
2\. Unstable epilepsy. 3. Unstable cardiovascular pathology (coronary heart disease, major hypertension, heart failure etc.).
4\. wearing a pacemaker. 5. Dermatological problems contraindicate the application of surface electrodes.
6\. body weight\> 100kg
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03721861
Study Brief:
Protocol Section:
NCT03721861