Recruiting

Observational Study

Sponsor:

Medical University of South Carolina

Code:

NCT05492188

Conditions

Spinal Cord Injuries

Neuropathic Pain

Neurological Injury

Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Operant Conditioning of Cutaneous Reflexes

Study Details

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

Study ID

NCT05492188

Start date

Mar 27, 2023

Status verified date

Oct, 2025

Completion date

Oct 1, 2026

Anticipated

Primary completion date

Oct 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

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.

Primary outcome measure

  • Change in minimum stimulation intensity required to barely detect the sensation (perceived threshold, perT) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Blair Dellenbach, MSOT

843-792-6313stecb@musc.edu

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Blair Dellenbach, MSOT

843-792-6313

More Information

Sponsor

Medical University of South Carolina

Last update posted

Oct 10, 2025

Last verified

Oct, 2025

Keywords

  • Neuroplasticity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2025-10-10.