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

Official title

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

Overview

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.

Interventions

• Behavioral 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 measures

• 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]

Secondary outcome measures (8)

• Change in the level of assistance required to walk 10 meters as measured by the Walking Index for Spinal Cord Injury (WI-SCI) [Time frame: Before Baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention]
• Change in level of spasticity in the more affected leg as measured by the Modified Ashworth Scale (MAS) [Time frame: Before Baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention]
• Change in balance as measured by Berg Balance Scale [Time frame: Before Baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention]
• Change in basic functional independence as measured by the Spinal Cord Independence Measure (SCIM III) [Time frame: Before Baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention]
• Change in functional independence as measured by the Functional Independence Measure (FIM) [Time frame: Before Baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention]
• Change in quality of life as measured by Spinal Cord Injury Quality of Life and Participation Questionnaire (SCI-QOL) [Time frame: Before Baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention]
• Change is strength of key muscles in the lower extremity as measured by Manual Muscle Testing (MMT) [Time frame: Before Baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention]
• Change in dynamic and static muscle length and joint range of motion (ROM) as measured by Tardieu Scale [Time frame: Before Baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention]

Eligibility criteria

Inclusion criteria

• 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
• functionally and medically stable for at least 3 months
• medical clearance to participate
• 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

• 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)
• 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)
• a cognitive impairment that precludes giving informed consent (e.g., severe intellectual disability)
• 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)
• deep vein thrombosis within the past 6 months
• depression (due to potential interference of anti-depressant medication with the intervention and possible reduced participation reliability)
• pregnancy (due to expected changes in weight and posture and potentially unstable medical condition).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 2 centers

• Medical University of South Carolina — Charleston
• Medical University of South Carolina — Charleston

Identifiers

NCT: NCT05094362 · 00095583 · 4U44NS114420-03

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗