~2 spots leftby Oct 2025

Reflex Training for Neuropathic Pain in Spinal Cord Injury

Recruiting in Palo Alto (17 mi)
AT
Overseen byAiko Thompson, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Medical University of South Carolina
Disqualifiers: Motoneuron injury, Cardiac condition, Pregnancy, others
No Placebo Group
Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

The purpose of the second part of the study is to examine the effect of reflex training in the leg to decrease neuropathic pain. For this, the researchers are recruiting 15 individuals with neuropathic pain due to spinal cord injury to participate in the reflex training procedure. The study involves approximately 50 visits with a total study duration of about 6.5 months (3 months for baseline and training phases followed by 1 month and 3 month follow-up visits).

Will I have to stop taking my current medications?

The trial requires that you keep taking your current medications without any changes for at least 3 months. If you are on anti-spasticity medication, you can continue using it as usual.

What data supports the effectiveness of the treatment Operant Conditioning of Cutaneous Reflexes for neuropathic pain in spinal cord injury?

Research on operant conditioning of spinal reflexes shows promising results in both animals and humans, indicating that this approach can help modify reflex behaviors through brain and spinal cord plasticity. This suggests potential benefits for managing neuropathic pain in spinal cord injury patients.12345

Is reflex training for neuropathic pain in spinal cord injury safe?

Research on reflex training, also known as operant conditioning of spinal reflexes, has been conducted in animals and humans, showing promising results without significant safety concerns. Studies have demonstrated that this method can safely modify reflexes in people with spinal cord injuries, suggesting it is generally safe for human use.46789

How does the Reflex Training Procedure treatment differ from other treatments for neuropathic pain in spinal cord injury?

The Reflex Training Procedure is unique because it uses operant conditioning to modify spinal reflexes, promoting plasticity (the ability to change and adapt) in the nervous system, which can improve motor function and potentially reduce pain. Unlike traditional treatments that may rely on medication, this approach focuses on retraining the body's reflex pathways to enhance recovery.18101112

Research Team

AT

Aiko Thompson, PhD

Principal Investigator

Medical University of South Carolina

Eligibility Criteria

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.

Inclusion Criteria

My neuropathic pain affects my lower leg.
My spinal cord injury has been stable for over a year.
My current medication will stay the same for the next 3 months.
See 2 more

Exclusion Criteria

I use electrical stimulation on my leg every day.
I cannot feel anything in my foot.
I have severe nerve pain or tingling that is not under control.
See 5 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants undergo baseline assessments including cutaneous reflex examination and sensation assessment

3 months
6 visits (in-person)

Conditioning

Participants complete 30 conditioning sessions to alter cutaneous reflexes and reduce neuropathic pain

3 months
30 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 months
2 visits (in-person)

Treatment Details

Interventions

  • Operant Conditioning of Cutaneous Reflexes (Behavioral Intervention)
Trial OverviewThe 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.
Participant Groups
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 Clinic Near You

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials
994
Recruited
7,408,000+
Dr. Erik Summers profile image

Dr. Erik Summers

Medical University of South Carolina

Chief Medical Officer

MD from University of Alabama at Birmingham

Dr. Patrick J. Cawley profile image

Dr. Patrick J. Cawley

Medical University of South Carolina

Chief Executive Officer

MD, MBA

Findings from Research

Operant conditioning of spinal reflexes has evolved over 35 years from basic science to a promising rehabilitation therapy for spinal cord injuries, showing significant potential for enhancing nervous system plasticity.
Initial studies in both animal models and humans indicate that reflex conditioning can lead to exciting therapeutic outcomes, highlighting the importance of basic research in informing clinical applications.
Operant conditioning of spinal reflexes: from basic science to clinical therapy.Thompson, AK., Wolpaw, JR.[2022]
In a rat model of spinal cord injury (SCI), different pain assessment methods revealed that brainstem reflexes and aversive behaviors were more indicative of pain at the level of injury, while below-level stimulation primarily triggered spastic reflexes rather than pain-like responses.
The study suggests that traditional spinal reflex measures are not suitable for assessing pain in SCI models, and emphasizes the importance of using cortical-dependent methods, like the place escape/avoidance paradigm (PEAP), for accurately evaluating central pain mechanisms.
Spinal-, brainstem- and cerebrally mediated responses at- and below-level of a spinal cord contusion in rats: evaluation of pain-like behavior.Baastrup, C., Maersk-Moller, CC., Nyengaard, JR., et al.[2021]
Operant conditioning protocols can effectively modify spinal reflexes, which are fundamental behaviors, providing valuable insights into the mechanisms of learning.
These protocols can also promote neural plasticity, potentially aiding in the recovery of motor skills like walking in individuals with spinal cord injuries or related disorders.
The simplest motor skill: mechanisms and applications of reflex operant conditioning.Thompson, AK., Wolpaw, JR.[2021]

References

Longitudinal study of wind-up responses after graded spinal cord injuries in the adult rat. [2013]
A novel affective-motivational-based Overground System for detecting spinal cord injury-associated thermal and mechanical hypersensitivity in rats. [2019]
Promoting Gait Recovery and Limiting Neuropathic Pain After Spinal Cord Injury. [2018]
Operant conditioning of spinal reflexes: from basic science to clinical therapy. [2022]
Spinal-, brainstem- and cerebrally mediated responses at- and below-level of a spinal cord contusion in rats: evaluation of pain-like behavior. [2021]
The simplest motor skill: mechanisms and applications of reflex operant conditioning. [2021]
Operant conditioning of spinal stretch reflexes in patients with spinal cord injuries. [2022]
Targeted neuroplasticity for rehabilitation. [2018]
Afferent stimulation inhibits abnormal cutaneous reflex activity in patients with spinal cord injury spasticity syndrome. [2018]
Analgesic effect of paired associative stimulation in a tetraplegic patient with severe drug-resistant neuropathic pain: a case report. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Modulation in spinal circuits and corticospinal connections following nerve stimulation and operant conditioning. [2020]
Noxious radiant heat evokes bi-component nociceptive withdrawal reflexes in spinal cord injured humans-A clinical tool to study neuroplastic changes of spinal neural circuits. [2023]