Actively Recruiting
Operant Conditioning of Spinal Reflexes Training System--Reflex Operant Down Conditioning
Led by Medical University of South Carolina · Updated on 2025-09-09
25
Participants Needed
2
Research Sites
175 weeks
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
The purpose of this study is to validate the capacity of a reflex training system to change the size of the targeted reflex. For this, the researchers are recruiting 25 individuals with chronic incomplete SCI who have spasticity in the leg to participate in the reflex training procedure. The study involves approximately 45 visits with a total study duration of about 6 months.
CONDITIONS
Official 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 occurring 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 the plantarflexor muscles at least on one side, including hyperreactivity to Achilles tendon tap and increased muscle tone (score >1 on Modified Ashworth scale)
- 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 like baclofen, diazepam, and tizanidine, will remain stable during the conditioning period; medication and dosage will be monitored throughout the study
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 like Multiple Sclerosis, Traumatic Brain Injury, Stroke, or Parkinson's disease
- Conditions preventing lower limb mobility testing or weight bearing, including fractures, severe sprains/strains, or recent botox muscle injections (orthotic knee hyperextension allowed; braces can be worn if severe)
- Cognitive impairments preventing informed consent, such as severe intellectual disability
- Daily use of functional electrical stimulation (FES) foot-drop devices or FES bicycles (arm FES allowed)
- Deep vein thrombosis within the past 6 months
- Depression that may interfere with medication or participation reliability
- Pregnancy due to expected weight, posture changes, and medical instability
AI-Screening
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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
CONTACT
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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