Recruiting

Reflex Operant Conditioning

Sponsor:

Medical University of South Carolina

Code:

NCT05094362

Conditions

Spinal Cord Injuries

Neurological Injury

Paralysis

Spasticity, Muscle

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Spinal Reflex Operant Down Conditioning

Study Details

Brief summary:

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

Spinal Cord Injuries

Neurological Injury

Paralysis

Spasticity, Muscle

Study ID

NCT05094362

Start date

Aug 23, 2023

Status verified date

Sep, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Spinal Reflex Operant Down Conditioning

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.

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 ]
  • Change in walking speed (m/s) as measured by the 10-meter Walk Test (10MWT) [ Time Frame: Before Baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention ]
  • Change in walking distance (meters) as measured by the 6-minute walk test [ Time Frame: Before Baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention ]

Central Contacts and Locations

Central contacts

Blair Dellenbach, MSOT

843-792-6313stecb@musc.edu

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Blair Dellenbach, MSOT

843-792-6313stecb@musc.edu

More Information

Sponsor

Medical University of South Carolina

Last update posted

Sep 9, 2025

Last verified

Sep, 2025

Keywords

  • Neuroplasticity
  • Spinal Reflex

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2025-09-09.