Clinical trial NCT05094362: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Neurological Injury
Paralysis
Spasticity, Muscle
Keywords: Neuroplasticity
Spinal Reflex
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2021-10-26
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Change in reflex activity as measured by the H-reflex amplitude (mV) in response to nerve stimulation
timeFrame: Before Baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention
measure: Change in walking speed (m/s) as measured by the 10-meter Walk Test (10MWT)
timeFrame: Before Baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention
measure: Change in walking distance (meters) as measured by the 6-minute walk test
timeFrame: Before Baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention
Secondary outcomes:
measure: Change in the level of assistance required to walk 10 meters as measured by the Walking Index for Spinal Cord Injury (WI-SCI)
timeFrame: Before Baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention
measure: Change in level of spasticity in the more affected leg as measured by the Modified Ashworth Scale (MAS)
timeFrame: Before Baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention
measure: Change in balance as measured by Berg Balance Scale
timeFrame: Before Baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention
measure: Change in basic functional independence as measured by the Spinal Cord Independence Measure (SCIM III)
timeFrame: Before Baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention
measure: Change in functional independence as measured by the Functional Independence Measure (FIM)
timeFrame: Before Baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention
measure: Change in quality of life as measured by Spinal Cord Injury Quality of Life and Participation Questionnaire (SCI-QOL)
timeFrame: Before Baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention
measure: Change is strength of key muscles in the lower extremity as measured by Manual Muscle Testing (MMT)
timeFrame: Before Baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention
measure: Change in dynamic and static muscle length and joint range of motion (ROM) as measured by Tardieu Scale
timeFrame: Before Baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Aiko Thompson, PhD
role: PRINCIPAL_INVESTIGATOR
References: