Status:
COMPLETED
Effects of Remote Ischemic Conditioning on Hand Use in Individuals With SCI and ALS
Lead Sponsor:
Bronx VA Medical Center
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Spinal Cord Injuries
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Rehabilitation interventions such as physical training and neural stimulation after spinal cord injury (SCI) have been shown to increase neural plasticity. However, both physical training and neural s...
Detailed Description
Most spinal cord injuries (SCI) are not full transections, indicating that there are residual nerve circuits after injury. Rehabilitation interventions after SCI, including physical training and neura...
Eligibility Criteria
Inclusion
- Able-bodied participants
- Age between 18 and 75 years;
- No known central or peripheral neurological disease or injury.
- SCI participants
- Age between 18 and 75 years;
- Chronic (more than 12 months since injury) motor-incomplete SCI between neurological levels C2-C8
- Detectable F-wave responses of the left or right abductor pollicis brevis (APB) to median nerve stimulation;
- Detectable motor evoked potentials in left or right APB muscles to transcranial magnetic stimulation;
- Able to perform thumb-middle finger opposition pinch task with detectable APB EMG muscle activity.
- ALS participants
- Age between 21 and 75 years;
- Diagnosis of probable or definite ALS.
- 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.
- Detectable motor evoked potentials in left or right APB muscles to transcranial magnetic stimulation;
- Able to perform thumb-middle finger opposition pinch task with detectable APB electromyography (EMG) muscle activity.
Exclusion
- Multiple spinal cord lesions;
- History of seizures;
- Use of medications that significantly lower seizure threshold, such as amphetamines and bupropion;
- History of implanted brain/spine/nerve stimulators, aneurysm clips, or cardiac pacemaker/defibrillator;
- 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);
- Any other contraindication to undergoing magnetic resonance imaging (except for claustrophobia);
- Clinically significant infection of any kind (urinary tract, pulmonary, skin or other)
- Significant coronary artery or cardiac conduction disease;
- Open skin lesions over the neck, shoulders, or arms;
- Pregnancy
- 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.
Key Trial Info
Start Date :
October 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2022
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03851302
Start Date
October 28 2019
End Date
October 31 2022
Last Update
November 10 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
James J. Peters VA Medical Center
The Bronx, New York, United States, 10468