RECRUITING

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

Conditions

Spinal Cord Injuries Neurological Injury Paralysis Spasticity, Muscle Neuroplasticity Spinal Reflex

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Operant Conditioning of Spinal Reflexes to Enhance Motor Function Recovery After Spinal Cord Injury

Quick Facts

Study Start:2023-08-23

Study Completion:2026-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05094362

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.)	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).

Inclusion Criteria

Exclusion 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.)

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).

Contacts and Locations

Study Contact

Blair Dellenbach, MSOT

CONTACT

843-792-6313

stecb@musc.edu

Principal Investigator

Aiko Thompson, PhD

PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Study Locations (Sites)

Medical University of South Carolina

Charleston, South Carolina, 29425

United States

Medical University of South Carolina

Charleston, South Carolina, 29425

United States

Collaborators and Investigators

Sponsor: Medical University of South Carolina

Aiko Thompson, PhD, PRINCIPAL_INVESTIGATOR, Medical University of South Carolina

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-23

Study Completion Date2026-03-31

Study Record Updates

Study Start Date2023-08-23

Study Completion Date2026-03-31

Terms related to this study

Keywords Provided by Researchers

Neuroplasticity
Spinal Reflex

Additional Relevant MeSH Terms

Spinal Cord Injuries
Neurological Injury
Paralysis
Spasticity, Muscle