Operant Conditioning of Spinal Reflexes Training System--Reflex Operant Down Conditioning

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
Medical University of South Carolina
Study ID
NCT05094362
Status
Recruiting
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Conditions

  • Neurological Injury
  • Paralysis
  • Spasticity, Muscle
  • Spinal Cord Injuries

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Spinal Reflex Operant Down Conditioning — BEHAVIORAL
    This is a training intervention in which people with a spinal cord injury are trained to reduce the activity of a certain spinal reflex. By decreasing this reflex, individuals decrease hyperactivity in the reflex and can reduce spasticity.

Study Details

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.

Key Dates

Start date
Aug 23, 2023
Status verified
Sep 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Validation of the new training system
    The researchers will measure changes in H-reflex size achieved with the use of the new system and compare these measures with the existing results in 25 spastic individuals with chronic incomplete SCI. Each participant completes 6 baseline sessions and 30 conditioning sessions. In the 30 conditioning sessions, the soleus H-reflex will be down-conditioned to decrease the activity of the hyperactive spinal stretch reflex pathway in people with spasticity that is characterized by exaggerated reflex activity. It is anticipated that the magnitude of reflex change obtained with the use of the new system would be greater or at least the same as the bench-marked values from the previous studies that used the old prototype reflex conditioning system.

Primary Outcome Measure

Change in reflex activity as measured by the H-reflex amplitude (mV) in response to nerve stimulation [ Time Frame: Before Baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Medical University of South CarolinaCharlestonSouth Carolina29425
Blair Dellenbach, MSOT
[email protected]
843-792-6313
Medical University of South CarolinaCharlestonSouth Carolina29425
Blair Dellenbach, MSOT
[email protected]
843-792-6313

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Medical University of South Carolina· Charleston, SC

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