Actively Recruiting
Operant Conditioning of Spinal Reflexes to Enhance Motor Function Recovery After Spinal Cord Injury
Led by Medical University of South Carolina · Updated on 2025-09-09
25
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Medical University of South Carolina
Lead Sponsor
N
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a reflex training system designed to change the size of a targeted spinal reflex in individuals with chronic incomplete spinal cord injury (SCI) who experience leg spasticity. The study aims to validate whether this new system can effectively decrease hyperactive spinal stretch reflex activity, which contributes to spasticity. About 25 participants who meet the criteria will take part in this interventional study lasting approximately six months with around 45 visits. Participants will undergo 6 baseline sessions followed by 30 conditioning sessions where the soleus H-reflex is trained to decrease activity. This operant conditioning intervention focuses on reducing the hyperactive spinal reflex pathway to potentially improve motor function. Researchers will compare the changes achieved with this new system to previous results from older training systems. The intervention is behavioral and involves training participants to reduce reflex activity. During the study, participants will have their reflex activity measured through H-reflex amplitude before baseline, after completing intervention sessions (about 10 weeks), and at 1 and 3 months post-intervention. Walking speed and distance will be assessed using the 10-meter Walk Test and 6-minute walk test. Additional assessments include walking assistance needs, spasticity levels, balance, functional independence, quality of life, muscle strength, and joint range of motion. Medication use will be monitored throughout, and participants will attend about 45 visits over six months for training and evaluations.
CONDITIONS
Brief Title
Operant Conditioning of Spinal Reflexes Training System--Reflex Operant Down Conditioning
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinically stable spinal cord injury above T11 that occurred at least one year ago
- Ability to walk at least 10 meters within 100 seconds with or without assistive devices (walker, crutches, or cane)
- Clinical signs of spasticity in plantarflexor muscles on at least one leg (hyperreactivity to Achilles tendon tap and Modified Ashworth scale score greater than 1)
- Presence of spastic hyperreflexia shown by exaggerated H-reflex
- Functionally and medically stable for at least 3 months
- Medical clearance to participate
- Expectation that current medications, including antispasticity drugs, will remain stable during conditioning period
You will not qualify if you...
- Motoneuron injury
- Cardiac conditions such as history of heart attack or pacemaker use
- Unstable medical conditions
- Pre-existing or confounding neurological conditions (e.g., Multiple Sclerosis, Traumatic Brain Injury, Stroke, Parkinson's disease)
- Conditions preventing lower extremity mobility testing or weight bearing (e.g., fracture, severe sprain/strain, recent botox injection)
- Cognitive impairment preventing informed consent
- Daily use of functional electrical stimulation (FES) foot-drop devices or FES bicycle (arm FES allowed)
- Deep vein thrombosis within the past 6 months
- Depression that may interfere with participation
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 2 weeks
Participants complete 6 baseline sessions to measure initial reflex activity and walking function before starting the training intervention.
6 visits (in-person)
Duration - Approximately 8 weeks
Participants undergo 30 training sessions of spinal reflex operant down conditioning to reduce hyperactive spinal reflexes and improve motor function after spinal cord injury.
30 visits (in-person)
Duration - 3 months
Participants are monitored to assess changes in reflex activity, walking speed, distance, spasticity, balance, functional independence, muscle strength, and quality of life after completing the intervention.
3 visits at 1 month and 3 months post-intervention
Trial Site Locations
Total: 2 locations
1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Not Yet Recruiting
2
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
Research Team
B
Blair Dellenbach, MSOT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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