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Behavioral Intervention
Reflex Training for Spinal Cord Injury
N/A
Recruiting
Led By Aiko Thompson, PhD
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinical signs of spasticity in the plantarflexor muscles at least unilaterally
Functionally and medically stable for at least 3 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention
Awards & highlights
Study Summary
This trial is testing whether a reflex training system can change the size of a reflex in people with chronic incomplete SCI. 25 participants are needed, and the study will last for 6 months with 45 visits.
Who is the study for?
This trial is for individuals with chronic incomplete spinal cord injury who can walk at least 10 meters, have leg spasticity, and are medically stable. They must be able to consent and not expect medication changes during the study. Excluded are those with unstable health, cognitive impairments, other neurological conditions, daily use of certain electrical stimulation devices, motoneuron injuries, serious heart issues, inability to test lower limb mobility or weight bearing, recent deep vein thrombosis or pregnancy.Check my eligibility
What is being tested?
The trial tests a reflex training system designed to reduce the size of targeted muscle reflexes in people with spinal cord injuries. Participants will undergo about 45 sessions over six months to see if this method can help manage spasticity in their legs by conditioning their spinal reflexes.See study design
What are the potential side effects?
While specific side effects aren't listed for this type of non-drug intervention, participants might experience discomfort or fatigue from repeated testing sessions. There may also be potential risks associated with any physical therapy-like activities such as muscle soreness.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have muscle stiffness in at least one of my lower legs.
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I have been medically stable without major changes for the last 3 months.
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I can walk 10 meters in 100 seconds, with or without help.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ before baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~before baseline, after completion of intervention sessions (approximately 10 weeks), 1 month and 3 months after the completion of intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in reflex activity as measured by the H-reflex amplitude (mV) in response to nerve stimulation
Change in walking distance (meters) as measured by the 6-minute walk test
Change in walking speed (m/s) as measured by the 10-meter Walk Test (10MWT)
Secondary outcome measures
Change in balance as measured by Berg Balance Scale
Change in basic functional independence as measured by the Spinal Cord Independence Measure (SCIM III)
Change in dynamic and static muscle length and joint range of motion (ROM) as measured by Tardieu Scale
+5 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Validation of the new training systemExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
933 Previous Clinical Trials
7,394,610 Total Patients Enrolled
2 Trials studying Paralysis
60 Patients Enrolled for Paralysis
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,340 Previous Clinical Trials
649,334 Total Patients Enrolled
12 Trials studying Paralysis
609 Patients Enrolled for Paralysis
Aiko Thompson, PhDPrincipal InvestigatorMedical University of South Carolina
1 Previous Clinical Trials
15 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of heart issues, like a heart attack or use a pacemaker.My spinal cord injury above T11 has been stable for over a year.I have had a deep vein thrombosis in the last 6 months.I cannot perform tests that require walking or standing.My current medications are expected to stay the same during the trial's start period.I use an FES device for foot-drop or exercise daily.I have a motor neuron injury.I have muscle stiffness in at least one of my lower legs.I do not have a history of MS, TBI, stroke, or Parkinson's disease.I am able to understand and consent to medical procedures.I have been diagnosed with depression.I have been medically stable without major changes for the last 3 months.I can walk 10 meters in 100 seconds, with or without help.I have a health condition that changes rapidly.You have a condition that causes exaggerated reflexes.
Research Study Groups:
This trial has the following groups:- Group 1: Validation of the new training system
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this investigation actively open?
"The information on clinicialtrials.gov reveals that patient recruitment for this particular trial has been paused since May 11th 2022, when it was last updated. Although no more participants are being accepted now, over one thousand other studies remain open to new enrollees."
Answered by AI
What objectives is this clinical experiment attempting to fulfill?
"The primary outcome of this investigation is the alteration in walking speed (m/s) as determined by the 10-meter Walk Test (10MWT), assessed at baseline, after conclusion of intervention sessions (~10 weeks), 1 month and 3 months post-intervention. Secondary outcomes include change in spasticity level on the Modified Ashworth Scale (MAS; 0 to 4 scale where a lower score indicates reduced spasticity); balance improvement measured through Berg Balance Scale (0 to 56 scale with increasing scores signifying better equilibrium and decreased risk of falls); together with variation in basic functional independence per Spinal cord Independence Measure III (SCIM"
Answered by AI
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