Back to resultsOperant Conditioning of Spinal Reflexes Training System--Reflex Operant Down Conditioning
Primary Purpose
Spinal Cord Injuries, Neurological Injury, Paralysis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Spinal Reflex Operant Down Conditioning
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Neuroplasticity, Spinal Reflex
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).
Sites / Locations
- Medical University of South Carolina
- Medical University of South CarolinaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Validation of the new training system
Arm Description
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.
Outcomes
Primary Outcome Measures
Change in reflex activity as measured by the H-reflex amplitude (mV) in response to nerve stimulation
Decreased H-reflex amplitude indicates reduced reflex activity and a more normal reflex response to muscle activity
Change in walking speed (m/s) as measured by the 10-meter Walk Test (10MWT)
Speed of the participant's fastest comfortable walking speed across 10 meters. Decreased time (sec) demonstrates increased walking speed (m/s)
Change in walking distance (meters) as measured by the 6-minute walk test
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
Change in the level of assistance required to walk 10 meters as measured by the Walking Index for Spinal Cord Injury (WI-SCI)
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.
Change in level of spasticity in the more affected leg as measured by the Modified Ashworth Scale (MAS)
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).
Change in balance as measured by Berg Balance Scale
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.
Change in basic functional independence as measured by the Spinal Cord Independence Measure (SCIM III)
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.
Change in functional independence as measured by the Functional Independence Measure (FIM)
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).
Change in quality of life as measured by Spinal Cord Injury Quality of Life and Participation Questionnaire (SCI-QOL)
An increase in score on the SCI-QOL indicates an increase in quality of life.
Change is strength of key muscles in the lower extremity as measured by Manual Muscle Testing (MMT)
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.
Change in dynamic and static muscle length and joint range of motion (ROM) as measured by Tardieu Scale
An increase in joint range of motion (deg) indicates ROM more similar to individuals without injury
Full Information
NCT ID
NCT05094362
First Posted
October 14, 2021
Last Updated
August 25, 2023
Sponsor
Medical University of South Carolina
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
1. Study Identification
Unique Protocol Identification Number
NCT05094362
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 23, 2023 (Actual)
Primary Completion Date
March 31, 2026 (Anticipated)
Study Completion Date
March 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Neurological Injury, Paralysis, Spasticity, Muscle
Keywords
Neuroplasticity, Spinal Reflex
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Validation of the new training system
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Spinal Reflex Operant Down Conditioning
Intervention Description
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 Measure Information:
Title
Change in reflex activity as measured by the H-reflex amplitude (mV) in response to nerve stimulation
Description
Decreased H-reflex amplitude indicates reduced reflex activity and a more normal reflex response to muscle activity
Time Frame
Before Baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention
Title
Change in walking speed (m/s) as measured by the 10-meter Walk Test (10MWT)
Description
Speed of the participant's fastest comfortable walking speed across 10 meters. Decreased time (sec) demonstrates increased walking speed (m/s)
Time Frame
Before Baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention
Title
Change in walking distance (meters) as measured by the 6-minute walk test
Description
The distance walked in 6 minutes in measured. The participant is asked to walk at his/her fastest comfortable speed on an indoor walkway.
Time Frame
Before Baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention
Secondary Outcome Measure Information:
Title
Change in the level of assistance required to walk 10 meters as measured by the Walking Index for Spinal Cord Injury (WI-SCI)
Description
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.
Time Frame
Before Baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention
Title
Change in level of spasticity in the more affected leg as measured by the Modified Ashworth Scale (MAS)
Description
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).
Time Frame
Before Baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention
Title
Change in balance as measured by Berg Balance Scale
Description
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.
Time Frame
Before Baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention
Title
Change in basic functional independence as measured by the Spinal Cord Independence Measure (SCIM III)
Description
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.
Time Frame
Before Baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention
Title
Change in functional independence as measured by the Functional Independence Measure (FIM)
Description
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).
Time Frame
Before Baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention
Title
Change in quality of life as measured by Spinal Cord Injury Quality of Life and Participation Questionnaire (SCI-QOL)
Description
An increase in score on the SCI-QOL indicates an increase in quality of life.
Time Frame
Before Baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention
Title
Change is strength of key muscles in the lower extremity as measured by Manual Muscle Testing (MMT)
Description
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.
Time Frame
Before Baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention
Title
Change in dynamic and static muscle length and joint range of motion (ROM) as measured by Tardieu Scale
Description
An increase in joint range of motion (deg) indicates ROM more similar to individuals without injury
Time Frame
Before Baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Blair Dellenbach, MSOT
Phone
843-792-6313
Email
stecb@musc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aiko Thompson, PhD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Blair Dellenbach, MSOT
Phone
843-792-6313
Email
stecb@musc.edu
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Blair Dellenbach, MSOT
Phone
843-792-6313
Email
stecb@musc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Operant Conditioning of Spinal Reflexes Training System--Reflex Operant Down Conditioning
We'll reach out to this number within 24 hrs