15 Participants Needed

Reflex Training for Neuropathic Pain in Spinal Cord Injury

BD
Overseen ByBlair Dellenbach, MSOT
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Medical University of South Carolina
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

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

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
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.

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Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials
994
Recruited
7,408,000+

United States Department of Defense

Collaborator

Trials
940
Recruited
339,000+

Findings from Research

Rats with spinal cord injuries of varying severity exhibited similar reductions in pain sensitivity, indicating that the severity of the injury does not necessarily correlate with the level of pain experienced.
Increased wind-up responses, which reflect central excitability, were observed in all injured rats, with more severe injuries showing greater increases, suggesting that wind-up measurements can effectively assess changes in pain mechanisms after spinal cord injury.
Longitudinal study of wind-up responses after graded spinal cord injuries in the adult rat.Redondo Castro, E., Udina, E., Verdú, E., et al.[2013]
The newly designed Overground System allows for a more accurate assessment of pain-like behaviors in response to cold and mechanical stimuli in animals with spinal cord injury, addressing issues of hyperreflexia that can confound traditional testing methods.
Results showed that after spinal cord injury, animals exhibited significant changes in crossing behavior over different surfaces, indicating adaptive decision-making in response to pain stimuli, which can help tailor pain assessment methods for different types of hypersensitivity.
A novel affective-motivational-based Overground System for detecting spinal cord injury-associated thermal and mechanical hypersensitivity in rats.Dugan, EA., Sagen, J.[2019]
Individuals with spinal cord injuries often experience neuropathic pain during intensive gait rehabilitation, suggesting that pain and rehabilitation may not be independent issues as previously thought.
Research indicates that nociception (pain perception) and motor learning may share common neural mechanisms, which could impact rehabilitation strategies and outcomes for patients with spinal cord injuries.
Promoting Gait Recovery and Limiting Neuropathic Pain After Spinal Cord Injury.Mercier, C., Roosink, M., Bouffard, J., et al.[2018]

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]