Neuropathic Pain and Operant Conditioning of Cutaneous Reflexes After SCI

NCT ID: NCT05492188

Last Updated: 2025-10-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-27
• Study Completion Date: 2026-10-01

Brief Summary

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).

Detailed 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.

Conditions

Spinal Cord Injuries; Neuropathic Pain; Neurological Injury; Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Operant Conditioning of Cutaneous Reflexes

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.

Group Type: EXPERIMENTAL

Operant Conditioning of Cutaneous Reflexes

Intervention Type: BEHAVIORAL

This is a training intervention in which people with a spinal cord injury are trained to change (increase or decrease) the activity of a certain spinal reflex. By changing this reflex, it is hypothesized that individuals can reduce pain due to spinal cord injury.

Interventions

Operant Conditioning of Cutaneous Reflexes

This is a training intervention in which people with a spinal cord injury are trained to change (increase or decrease) the activity of a certain spinal reflex. By changing this reflex, it is hypothesized that individuals can reduce pain due to spinal cord injury.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Aiko Thompson

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aiko Thompson, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Blair Dellenbach, MSOT

Role: CONTACT

stecb@musc.edu

843-792-6313

Facility Contacts

Blair Dellenbach, MSOT

Role: primary

843-792-6313

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

CDMRP-SC210118

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

118771

Identifier Type: -

Identifier Source: org_study_id