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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
For participants with neuropathic pain, the area of neuropathic pain must include lower leg.
Neurologically stable (>1 year post SCI)
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

Study 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.Check my eligibility
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.See study design
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 below
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My neuropathic pain affects my lower leg.
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My spinal cord injury has been stable for over a year.
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My current medication will stay the same for the next 3 months.
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I can stand for at least 3 minutes with or without help.
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My spinal cord injury has been stable for over a year.

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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 more
Secondary outcome measures
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 more

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.

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
930 Previous Clinical Trials
7,393,796 Total Patients Enrolled
Aiko Thompson, PhDPrincipal InvestigatorMedical University of South Carolina
1 Previous Clinical Trials
25 Total Patients Enrolled

Media Library

Operant Conditioning of Cutaneous Reflexes (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05492188 — N/A
Spinal Cord Injury Research Study Groups: Operant Conditioning of Cutaneous Reflexes
Spinal Cord Injury Clinical Trial 2023: Operant Conditioning of Cutaneous Reflexes Highlights & Side Effects. Trial Name: NCT05492188 — N/A
Operant Conditioning of Cutaneous Reflexes (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05492188 — N/A
Spinal Cord Injury Patient Testimony for trial: Trial Name: NCT05492188 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are included in this medical trial?

"Affirmative. The clinicaltrials.gov portal indicates that this research trial commenced on March 27th 2023 and is still actively recruiting participants. 15 individuals are sought from a single location to take part in the experiment."

Answered by AI

Are there any vacancies available for individuals to join this trial?

"Affirmative, according to the information hosted on clinicaltrials.gov this medical trial is currently searching for participants. It was initially posted online on March 27th 2023 and last updated April 3rd 2023. 15 individuals are required at a singular test site."

Answered by AI

What end results are expected from this research endeavor?

"The primary purpose of this trial is to observe the modification in pain threshold (PainT) from baseline till completion of training protocol, 1 month follow-up and 3 months follow-up. Additional secondary goals include tracking any changes in quality of life with [Spinal cord injury](https://www.withpower.com/clinical-trials/spinal-cord-injury) Quality of Life and Participation Questionnaire (SCI-QOL), basic functional independence as per Spinal Cord Independence Measure (SCIM III) and Functional Independence Measure (FIM). SCI-QOL comprises 6 self care items with a subscore ranging between 0 - 20; 4 respiration & sphincter management items having subscore range 0 - 40"

Answered by AI

Who else is applying?

What site did they apply to?
Medical University of South Carolina
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
1
What state do they live in?
Ohio

Why did patients apply to this trial?

I am hoping I can benefit from your trials. I’ve just been looking into to studies anywhere that can truly help provide me with any other options to help live with this problem. I am constantly hurting, And i’ve been seeking all over for places that are doing studies to help me gain more knowledge and this could be something to help me and other people who are struggling with chronic pain at a young age. I’m 28, too young for surgery .
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

Will you do spinal cord injury repair trials?
PatientReceived 1 prior treatment
~9 spots leftby Oct 2025