Effects of Remote Ischemic Conditioning on Hand Use in Individuals With SCI and ALS (NCT03851302) | Clinical Trial Compass
CompletedNot Applicable
Effects of Remote Ischemic Conditioning on Hand Use in Individuals With SCI and ALS
United States21 participantsStarted 2019-10-28
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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.
✓. 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.
Exclusion criteria
✕. Multiple spinal cord lesions;
What they're measuring
1
Percent Change of Electromyographic Responses After Remote Ischemic Conditioning (RIC) Plus Hand Isometric Exercise
Timeframe: Outcome measured immediately after completion of RIC plus isometric hand exercise. The RIC plus hand exercise duration is 60 minutes.
✕. 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;