N/A
N=21
Effects of Remote Ischemic Conditioning on Hand Use in Individuals With SCI and ALS
Spinal Cord Injuries · Amyotrophic Lateral Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT03851302 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: Percent Change of Electromyographic Responses After Remote Ischemic Conditioning (RIC) Plus Hand Isometric Exercise — 17.4; 22.2; -19.2; 79.7 change (%) from baseline
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Active Remote Ischemic Conditioning (Other); Sham Remote Ischemic Conditioning (Other); Isometric hand exercise (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bronx VA Medical Center
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change of Electromyographic Responses After Remote Ischemic Conditioning (RIC) Plus Hand Isometric Exercise |
17.4; 22.2; -19.2; 79.7; -6.1; 111.8 | — |
| SECONDARY Percent Change of Electromyographic Responses After RIC But Before Hand Isometric Exercise |
23.5; 21.6; -14.8; 59.9; 52.3; 200.1 | — |
| SECONDARY Percent Change of Electromyographic Responses 15 Mins After RIC Plus Hand Isometric Exercise |
15.2; 35.4; -5.1; 204.9; -46.7; -6.7 | — |
| SECONDARY Blood Pressure |
1.8; 4.4; 8.3; 3.4; -5.2; -3.4 | — |
| SECONDARY Heart Rate |
-0.8; -4.4; -5.0; 1.5; -6.0; -3.2 | — |
| SECONDARY Oxygen Saturation |
0.4; 0.6; 1.3; 0.3; 0; 2.3 | — |
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 stimulation require a large number of repetitions, and the retention of the intervention effects may be fleeting. In this proposal the investigators will test Remote ischemic conditioning (RIC), which has been shown to promote neural plasticity and has practical and theoretical advantages. RIC consists of transiently restricting blood flow to any 'remote' limb using a blood pressure cuff. This induces several of the body's systemic defensive reactions. RIC has been shown to improve motor learning. The investigators propose that RIC alters motor pathway excitability through a combination of systemic increases in plasticity-promoting factors and inhibition of inflammatory factors. The investigators have designed a clinical trial to test this hypothesis in 8 persons with SCI and 8 able-bodied controls. All participants will receive active/sham RIC plus a hand exercise. The investigators will measure effects on blood pressure, motor neuron excitability, and systemic inflammatory markers before and after RIC as well as after hand exercise. Starting July 2021, we will also enroll 5 individuals with Amyotrophic lateral sclerosis (ALS) in this study.
Eligibility Criteria
Able-bodied participants
- Age between 18 and 75 years;
- No known central or peripheral neurological disease or injury.
SCI participants
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03851302). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.