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

NCT ID: NCT05094362

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-23
• Study Completion Date: 2026-12-31

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Spinal Reflex Operant Down Conditioning

Intervention Type: 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.

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Aiko Thompson

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aiko Thompson, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status: NOT_YET_RECRUITING

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Blair Dellenbach, MSOT

Role: CONTACT

stecb@musc.edu

843-792-6313

Facility Contacts

Blair Dellenbach, MSOT

Role: primary

stecb@musc.edu

843-792-6313

Blair Dellenbach, MSOT

Role: primary

stecb@musc.edu

843-792-6313

Other Identifiers

4U44NS114420-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

00095583

Identifier Type: -

Identifier Source: org_study_id