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Behavioral Intervention
Reflex Training for Neuropathic Pain in 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
Neurologically stable (>1 year post SCI)
Ability to stand with or without an assistive device for at least 3 minutes at a time
Must not have
Daily use of electrical stimulation to the leg
Complete lack of cutaneous sensation around foot.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up completed at baseline, start of conditioning visits 13, 19, and 25, after completing 30 conditioning sessions, 1 month follow up, and 3 months follow up
Awards & highlights
No Placebo-Only Group
Summary
This trial will study the effects of reflex training on reducing neuropathic pain in people who have spinal cord injuries. 15 participants will be recruited for 6.5 months of visits.
Who is the study for?
This trial is for individuals with neuropathic pain in the lower leg due to spinal cord injury. They must be stable over a year post-injury, able to stand for at least 3 minutes, and on steady medication for 3 months. Excluded are those with motoneuron injuries, heart conditions, cognitive impairments or complete lack of sensation around the foot.
What is being tested?
The study tests reflex training aimed at reducing neuropathic pain after spinal cord injury. It involves about 50 sessions over roughly 6.5 months including baseline assessment, training phase and follow-up visits at one month and three months post-training.
What are the potential side effects?
While specific side effects aren't listed for this type of non-drug intervention, participants may experience discomfort or fatigue related to standing during sessions or potential changes in their pain levels.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My spinal cord injury has been stable for over a year.
Select...
I can stand for at least 3 minutes with or without help.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I use electrical stimulation on my leg every day.
Select...
I cannot feel anything in my foot.
Select...
I have severe nerve pain or tingling that is not under control.
Select...
I have a known heart condition.
Select...
I have difficulty with memory or thinking clearly.
Select...
I have a motor neuron injury.
Select...
I regularly use electrical spinal stimulation for pain management.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ completed at baseline, start of conditioning visits 13, 19, and 25, after completing 30 conditioning sessions, 1 month follow up, and 3 months follow up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~completed at baseline, start of conditioning visits 13, 19, and 25, after completing 30 conditioning sessions, 1 month follow up, and 3 months follow up
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in minimum intensity at which the sensation covers the maximum area of skin (radiating threshold, RT)
Change in minimum intensity at which the stimulus become painful (pain threshold, PainT)
Change in minimum stimulation intensity required to barely detect the sensation (perceived threshold, perT)
+2 moreSecondary study objectives
Change in ability to perceive various types of sensations as indicated by Quantitative Sensory Testing (QST)
Change in basic functional independence as measured by the Spinal Cord Independence Measure (SCIM III)
Change in functional independence as measured by the Functional Independence Measure (FIM)
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Operant Conditioning of Cutaneous ReflexesExperimental Treatment1 Intervention
Each participant completes 6 baseline sessions and 30 conditioning sessions. In each of the 30 conditioning sessions, while the participant is standing nerves in the lower leg and ankle are stimulated to activate the reflex. The participant attempts to change the reflex activity based on visual feedback. In this way the cutaneous reflex (skin reflex) will be changed to decrease neuropathic pain resulting from spinal cord injury.
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Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
966 Previous Clinical Trials
7,399,605 Total Patients Enrolled
7 Trials studying Pain
302 Patients Enrolled for Pain
Aiko Thompson, PhDPrincipal InvestigatorMedical University of South Carolina
1 Previous Clinical Trials
25 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My neuropathic pain affects my lower leg.I use electrical stimulation on my leg every day.My spinal cord injury has been stable for over a year.I cannot feel anything in my foot.I have severe nerve pain or tingling that is not under control.I have a known heart condition.My current medication will stay the same for the next 3 months.I can stand for at least 3 minutes with or without help.I have difficulty with memory or thinking clearly.I have a motor neuron injury.I regularly use electrical spinal stimulation for pain management.
Research Study Groups:
This trial has the following groups:- Group 1: Operant Conditioning of Cutaneous Reflexes
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.
Pain Patient Testimony for trial: Trial Name: NCT05492188 — N/A
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