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 range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.
. 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;
. 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;