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NCT Number: NCT05492188

Neuropathic Pain and Operant Conditioning of Cutaneous Reflexes After SCI

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).

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Neuralgia Neurologic Manifestations Neurological Injury Neuromuscular Diseases Neuropathic Pain Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location status: Recruiting

Location contact

Blair Dellenbach, MSOT

CONTACT

843-792-6313

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. 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

    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.

  2. 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

    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.

  3. 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

    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.

  4. 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

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

  5. 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

    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).

Secondary outcomes

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

    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

    The QST is a battery of assessments that measure sensory thresholds for pain, touch, vibration, and hot and cold temperature sensations.

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

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

    An increase in the the score on the SCIM III indicates increased basic functional independence. This is a self report questionnaire with 19 items in three sub-scales: (1) self-care (6 items, subscore 0-20); (2) respiration and sphincter management (4 items, subscore 0-40); and (3) mobility (9 items, subscore 0-40). The total score ranges from 0-100, with higher scores indicated increase independence.

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

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

    An increase in the score on the FIM indicates and increase in functional independence. This 18-item, clinician-reported scale assesses function in 6 areas including self-care, continence, mobility, transfers, communication, and cognition. Each of the 18 items is graded on a scale of 1-7 based on level of independence in that item (1 = total assistance required, 7 = complete independence).

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

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

    An increase in score on the SCI-QOL indicates an increase in quality of life

Study contacts

Contact information is provided by the study sponsor or research team.

Blair Dellenbach, MSOT

CONTACT

[email protected]

843-792-6313

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

Targeted Spinal Cord Plasticity for Alleviating SCI-related Neuropathic Pain

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 8, 2022
Registry last updated
Oct 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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