Training system to improve spinal reflexes in individuals with spinal cord injuries
Operant Conditioning of Spinal Reflexes to Enhance Motor Function Recovery After Spinal Cord Injury
This study is testing a new training system to see if it can help people with spinal cord injuries reduce leg stiffness and improve their movement.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 2 sites (Charleston, South Carolina and 1 other locations) |
| Trial ID | NCT05094362 on ClinicalTrials.gov |
What this trial studies
This study aims to validate a reflex training system designed to modify the size of targeted spinal reflexes in individuals with chronic incomplete spinal cord injuries (SCI) who experience spasticity in their legs. It involves recruiting 25 participants who will undergo approximately 45 visits over a six-month period to engage in spinal reflex operant down conditioning. The goal is to assess the effectiveness of this intervention in enhancing neuroplasticity and improving motor function. Participants will be closely monitored for their ability to ambulate and their spasticity levels throughout the study.
Who should consider this trial
Good fit: Ideal candidates are individuals with chronic incomplete spinal cord injuries above T11 who exhibit spasticity in their legs and can ambulate at least 10 meters within 100 seconds.
Not a fit: Patients with complete spinal cord injuries or those unable to ambulate 10 meters within the specified time frame may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could lead to improved motor function and reduced spasticity for patients with spinal cord injuries.
How similar studies have performed: While the approach of operant conditioning for spinal reflexes is innovative, similar studies have shown promise in enhancing neuroplasticity and motor function in related conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. a clinically stable spinal cord injury (above T11) that occurred at least one year previously 2. the ability to ambulate at least 10 m with or without an assistive device (i.e., walker, crutches, or cane, not parallel bars) within 100 sec (those with 10-meter walking time \>100 sec are excluded because it is unlikely that they are able to participate in and complete our planned locomotion evaluation procedures) 3. clinical signs of spasticity in the plantarflexor muscles at least unilaterally (i.e., hyperreactivity to Achilles tendon tap, and increased muscle tone, score \>1 on Modified Ashworth scale) 4. spastic hyperreflexia reflected in exaggerated H-reflex 5. functionally and medically stable for at least 3 months 6. medical clearance to participate 7. reasonable expectation that current medications (including antispasticity medication such as baclofen, diazepam, and tizanidine) will not change over the conditioning period. Each participant's medication and dosage will be monitored and recorded throughout the study. Once enrolled, the subject will remain enrolled even if medication changes. (Because only neurologically stable subjects will enter this study, medication changes will be unlikely.) Exclusion Criteria: 1. motoneuron injury; 2. a cardiac condition (history of myocardial infarct, pacemaker use, etc.) 3. an unstable medical condition 4. a pre-existing or confounding neurological condition (e.g., history of Multiple Sclerosis (MS), Traumatic Brain Injury (TBI), Stroke, Parkinson's disease) 5. a condition that prevents lower extremity mobility testing or weight bearing (e.g. fracture, severe sprain/strain, botox muscular injection) (orthotic knee hyperextension is not excluded; in severe cases of knee hyperextension, the brace can be worn during the study sessions) 6. a cognitive impairment that precludes giving informed consent (e.g., severe intellectual disability) 7. use of a functional electrical stimulation (FES) foot-drop stimulator or an FES bicycle on a daily basis (FES applied to the arm is acceptable) 8. deep vein thrombosis within the past 6 months 9. depression (due to potential interference of anti-depressant medication with the intervention and possible reduced participation reliability) 10. pregnancy (due to expected changes in weight and posture and potentially unstable medical condition).
Where this trial is running
Charleston, South Carolina and 1 other locations
- Medical University of South Carolina — Charleston, South Carolina, United States (Not_yet_recruiting)
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Aiko Thompson, PhD — Medical University of South Carolina
- Study coordinator: Blair Dellenbach, MSOT
- Email: stecb@musc.edu
- Phone: 843-792-6313
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.