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 @ 3:56 AM
Ignite Modification Date:
2025-12-25 @ 3:56 AM
NCT ID:
NCT03851302
Eligibility Criteria:
Able-bodied participants
1. Age between 18 and 75 years;
2. No known central or peripheral neurological disease or injury.
SCI participants
Inclusion Criteria:
1. Age between 18 and 75 years;
2. Chronic (more than 12 months since injury) motor-incomplete SCI between neurological levels C2-C8
3. Detectable F-wave responses of the left or right abductor pollicis brevis (APB) to median nerve stimulation;
4. Detectable motor evoked potentials in left or right APB muscles to transcranial magnetic stimulation;
5. Able to perform thumb-middle finger opposition pinch task with detectable APB EMG muscle activity.
ALS participants
1. Age between 21 and 75 years;
2. Diagnosis of probable or definite ALS.
3. Incomplete weakness of left or right wrist or hand muscles: score of 2, 3, or 4 (out of 5) on manual muscle testing of finger extension, finger flexion, or finger abduction.
4. Detectable motor evoked potentials in left or right APB muscles to transcranial magnetic stimulation;
5. Able to perform thumb-middle finger opposition pinch task with detectable APB electromyography (EMG) muscle activity.
Exclusion Criteria:
1. Multiple spinal cord lesions;
2. History of seizures;
3. Use of medications that significantly lower seizure threshold, such as amphetamines and bupropion;
4. History of implanted brain/spine/nerve stimulators, aneurysm clips, or cardiac pacemaker/defibrillator;
5. Any extremity soft tissue, orthopedic, or vascular condition or injury that may contraindicate remote limb ischemic conditioning (RLIC) (uncontrolled hypertension, peripheral vascular disease, hematological disease, severe hepatic or renal dysfunction);
6. Any other contraindication to undergoing magnetic resonance imaging (except for claustrophobia);
7. Clinically significant infection of any kind (urinary tract, pulmonary, skin or other)
8. Significant coronary artery or cardiac conduction disease;
9. Open skin lesions over the neck, shoulders, or arms;
10. Pregnancy
11. Unsuitable for study participation as determined by study physician. In addition, a medical record review will be conducted to identify any other medical concerns that might increase the risks associated with participation.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03851302
Study Brief:
Protocol Section:
NCT03851302