Neuropathic Pain and Operant Conditioning of Cutaneous Reflexes After SCI

Medical University of South Carolina (MUSC)

Status: Enrolling

Conditions: Spinal Cord Injuries; Neuropathic Pain; Pain; Neurological Injury

Treatments: Behavioral: Operant Conditioning of Cutaneous Reflexes

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05492188

CDMRP-SC210118 (Other Grant/Funding Number)

118771

Details and patient eligibility

About

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).

Full description

As part of the larger study of the relationship between reflexes in the leg and the presence of neuropathic pain, the researchers are also recruiting 30 individuals with spinal cord injury (SCI) total, 15 individuals with neuropathic pain due to SCI and 15 individuals without neuropathic pain. For this portion of the study, there are 2 visits. The first visit will examine cutaneous reflexes in the leg. During the second visit, the study team will assess sensation in the leg and administer questionnaires about pain, functioning, and quality of life. This portion of the study does not involve an intervention.

The study will then recruit 15 individuals who will participate in reflex training, as described in the brief summary.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. neurologically stable (>1 year post SCI)
2. medical clearance to participate
3. ability to stand with or without an assistive device for at least 3 minutes at a time
4. expectation that current medication will be maintained without change for at least 3 months (stable use of anti-spasticity medication is accepted)
5. For participants with neuropathic pain, the area of neuropathic pain must include lower leg.

Exclusion criteria

1. motoneuron injury
2. known cardiac condition
3. medically unstable condition (incl. pregnancy)
4. cognitive impairment
5. uncontrolled peripheral neuropathy
6. frequent use of electrical spinal stimulation (either transcutaneous or epidural) for pain treatment
7. daily use of electrical stimulation to the leg
8. complete lack of cutaneous sensation around foot.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Operant Conditioning of Cutaneous Reflexes

Experimental group

Description:

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.

Treatment:

Behavioral: Operant Conditioning of Cutaneous Reflexes