Neuropathic Pain and Operant Conditioning of Cutaneous Reflexes After SCI

NCT05492188 | Recruiting DMC

• 2 other identifiers: 118771CDMRP-SC210118
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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).

Conditions

Spinal Cord Injuries; Neuropathic Pain; Neurological Injury; Pain

Keywords

Neuroplasticity

Outcome Measures

Primary Outcomes (5)

• Change in minimum stimulation intensity required to barely detect the sensation (perceived threshold, perT)

  This is measured by slowly increasing the nerve stimulation and recording the minimum intensity of stimulation at which the participant is barely able to perceive the sensation. A decrease in this threshold would demonstrate improved sensation.

  change from baseline to immediately after completing the training protocol, at 1 month follow up and at 3 months follow up

• Change in minimum intensity at which the sensation covers the maximum area of skin (radiating threshold, RT)

  This is measured by slowly increasing the nerve stimulation and recording the minimum intensity of stimulation at which the sensation covers the maximum skin area). A decrease in this threshold indicates improved sensation.

  change from baseline to immediately after completing the training protocol, at 1 month follow up and at 3 months follow up

• Change in minimum intensity at which the stimulus become painful (pain threshold, PainT)

  This is measured by slowly increasing the nerve stimulation and recording the intensity of stimulation at which the stimulation first becomes painful. An increase in this threshold indicates an increased tolerance to pain.

  change from baseline to immediately after completing the training protocol, at 1 month follow up and at 3 months follow up

• Change in pain as measured by the McGill Pain Questionnaire (MPQ)

  The MPQ is a self-report questionnaire that assesses quality and intensity of pain. Scores range from 0 (no pain) to 78 (severe pain).

  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

• Change in neuropathic pain as measured by the Neuropathic Pain Symptom Inventory (NPSI)

  The NPSI is a self-report questionnaire that characterizes neuropathic pain symptom severity. Participants rate different symptoms of neuropathic pain on a scale of 0 (no pain) to 10 (intense pain).

  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

Secondary Outcomes (4)

• Change in ability to perceive various types of sensations as indicated by Quantitative Sensory Testing (QST)

  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

• Change in basic functional independence as measured by the Spinal Cord Independence Measure (SCIM III)

  Completed at baseline, after completing 30 conditioning sessions, 1 month follow up, and 3 months follow up

• Change in functional independence as measured by the Functional Independence Measure (FIM)

  Completed at baseline, after completing 30 conditioning sessions, 1 month follow up, and 3 months follow up

• Change in quality of life as measured by Spinal Cord Injury Quality of Life and Participation Questionnaire (SCI-QOL)

  Completed at baseline, after completing 30 conditioning sessions, 1 month follow up, and 3 months follow up

Study Arms (1)

Operant Conditioning of Cutaneous Reflexes

EXPERIMENTAL

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.

Behavioral: Operant Conditioning of Cutaneous Reflexes

Interventions

Operant Conditioning of Cutaneous Reflexes 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.

Operant Conditioning of Cutaneous Reflexes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• United States Department of Defense: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Neuralgia; Trauma, Nervous System; Pain

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Peripheral Nervous System Diseases; Neuromuscular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Aiko Thompson, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Blair Dellenbach, MSOT

CONTACT

843-792-6313; stecb@musc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 5, 2022
• First Posted: August 8, 2022
• Study Start: March 27, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: October 10, 2025

Record last verified: 2025-10

Locations

US (1)