Operant Conditioning of Spinal Reflexes Training System--Reflex Operant Down Conditioning
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of South Carolina
About this trial
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.
Eligibility criteria
Qualifiers
a clinically stable spinal cord injury (above T11) that occurred at least one year previously
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)
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)
spastic hyperreflexia reflected in exaggerated H-reflex
Disqualifiers
motoneuron injury;
a cardiac condition (history of myocardial infarct, pacemaker use, etc.)
an unstable medical condition
a pre-existing or confounding neurological condition (e.g., history of Multiple Sclerosis (MS), Traumatic Brain Injury (TBI), Stroke, Parkinson's disease)
Trial design
Treatments tested in this trial
- Spinal Reflex Operant Down Conditioning
Treatment groups
25 Participants
are divided into 1 treatment groupSponsors and collaborators
Medical University of South Carolina
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov