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

• ClinicalTrials.gov Identifier: NCT05094362
• Recruitment Status: Not yet recruiting
• First Posted: October 26, 2021
• Last Update Posted: May 15, 2023
• Sponsor: Medical University of South Carolina
• Information provided by (Responsible Party): Aiko Thompson, Medical University of South Carolina

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Spinal Cord Injuries; Neurological Injury; Paralysis; Spasticity, Muscle	Behavioral: Spinal Reflex Operant Down Conditioning	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 25 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Operant Conditioning of Spinal Reflexes to Enhance Motor Function Recovery After Spinal Cord Injury
• Estimated Study Start Date: June 1, 2023
• Estimated Primary Completion Date: March 31, 2026
• Estimated Study Completion Date: March 31, 2026

Arms and Interventions

Arm

Intervention/treatment

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.

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.

Outcome Measures

Primary Outcome Measures :

1. 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 ]
   Decreased H-reflex amplitude indicates reduced reflex activity and a more normal reflex response to muscle activity
2. 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 ]
   Speed of the participant's fastest comfortable walking speed across 10 meters. Decreased time (sec) demonstrates increased walking speed (m/s)
3. 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 ]
   The distance walked in 6 minutes in measured. The participant is asked to walk at his/her fastest comfortable speed on an indoor walkway.

Secondary Outcome Measures :

1. 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 ]
   WI-SCI classifies the level of assistance needed to perform the 10MWT; the scale is from 0-20 with 20 being no assistance required at all. An increase of score indicates increased level of independence while walking.
2. 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 ]
   A decrease in the score on the MAS indicates a decrease in spasticity. To measure spasticity, resistance to passive movement about a joint is tested at a range of velocities. The score ranges from 0-4 (i.e., 0: normal muscle tone; 4: rigid in flexion or extension).
3. 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 ]
   An increase in score on the Berg Balance scale indicates better balance and decreased fall risk. For each item, the score ranges from 0-4 with a maximum total score of 56.
4. 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 ]
   An increase in the the score on the SCIM III indicates increased basic functional independence. This is a self report questionnaire with 19 items in three sub-scales: (1) self-care (6 items, subscore 0-20); (2) respiration and sphincter management (4 items, subscore 0-40); and (3) mobility (9 items, subscore 0-40). The total score ranges from 0-100.
5. 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 ]
   An increase in the score on the FIM indicates and increase in functional independence. This 18-item, clinician-reported scale assesses function in 6 areas including self-care, continence, mobility, transfers, communication, and cognition. Each of the 18 items is graded on a scale of 1-7 based on level of independence in that item (1 = total assistance required, 7 = complete independence).
6. 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 ]
   An increase in score on the SCI-QOL indicates an increase in quality of life.
7. 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 ]
   To test the strength against the examiner's resistance and grading the patient's strength on a 0 to 5 scale. 0: No muscle activation; 1: Trace muscle activation, such as a twitch, without achieving full range of motion; 2: Muscle activation with gravity eliminated, achieving full range of motion; 3: Muscle activation against gravity, full range of motion; 4: Muscle activation against some resistance, full range of motion; 5: Muscle activation against examiner's full resistance, full range of motion.
8. 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 ]
   An increase in joint range of motion (deg) indicates ROM more similar to individuals without injury

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Contacts

Contact: Blair Dellenbach, MSOT; 843-792-6313; stecb@musc.edu

Locations

United States, South Carolina

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

Contact: Blair Dellenbach, MSOT 843-792-6313 stecb@musc.edu

Sponsors and Collaborators

Medical University of South Carolina

Investigators

• Principal Investigator: Aiko Thompson, PhD; Medical University of South Carolina

More Information

• Responsible Party: Aiko Thompson, Associate Professor, Medical University of South Carolina
• ClinicalTrials.gov Identifier: NCT05094362
• Other Study ID Numbers: 00095583
• First Posted: October 26, 2021
• Last Update Posted: May 15, 2023
• Last Verified: May 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Aiko Thompson, Medical University of South Carolina:

Neuroplasticity; Spinal Reflex

Additional relevant MeSH terms:

Muscle Spasticity; Spinal Cord Injuries; Paralysis; Trauma, Nervous System; Wounds and Injuries; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations