Spinal Cord InjuriesNCT05492188
Neuropathic Pain and Operant Conditioning of Cutaneous Reflexes After SCI
A study testing Operant Conditioning of Cutaneous Reflexes in people with Spinal Cord Injuries and Neuropathic Pain, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Neuropathic Pain, Neurological Injury
- What is being tested?
- Operant Conditioning of Cutaneous Reflexes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2023to 15 Jan 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Blair Dellenbach, MSOT, 843-792-6313
About this study
Official title: Targeted Spinal Cord Plasticity for Alleviating SCI-related Neuropathic Pain
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).
Read the 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
- Being tested
- Operant Conditioning of Cutaneous Reflexes
- Keywords
- Neuroplasticity
- Medical subject headings
- Spinal Cord Injuries, Neuralgia, Trauma, Nervous System, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Operant Conditioning of Cutaneous ReflexesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Operant Conditioning of Cutaneous Reflexes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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)
The QST is a battery of assessments that measure sensory thresholds for pain, touch, vibration, and hot and cold temperature sensations.
Measured: 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)
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.
Measured: 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)
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).
Measured: 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)
An increase in score on the SCI-QOL indicates an increase in quality of life
Measured: Completed at baseline, after completing 30 conditioning sessions, 1 month follow up, and 3 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start27 Mar 2023
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Aiko Thompson, Medical University of South Carolina
- Investigators
- Aiko Thompson, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05492188
- Sponsor's protocol ID
- 118771
- Other IDs
- CDMRP-SC210118
- Status last verified
- Oct 2026
- First submitted
- 5 Aug 2022
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No