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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 below

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My spinal cord injury has been stable for over a year.

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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:

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I use electrical stimulation on my leg every day.

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I cannot feel anything in my foot.

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I have severe nerve pain or tingling that is not under control.

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I have a known heart condition.

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I have difficulty with memory or thinking clearly.

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I have a motor neuron injury.

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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

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

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 more

Secondary 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 more

Awards & 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.

0 / 9Eligibility criteria met