Clinical trial NCT05492188: Neuropathic Pain and Operant Conditioning of Cutaneous Reflexes After SCI
Official title: Targeted Spinal Cord Plasticity for Alleviating SCI-related Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Neuropathic Pain
Neurological Injury
Pain
Keywords: Neuroplasticity
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2022-08-08
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in minimum stimulation intensity required to barely detect the sensation (perceived threshold, perT)
timeFrame: change from baseline to immediately after completing the training protocol, at 1 month follow up and at 3 months follow up
measure: Change in minimum intensity at which the sensation covers the maximum area of skin (radiating threshold, RT)
timeFrame: change from baseline to immediately after completing the training protocol, at 1 month follow up and at 3 months follow up
measure: Change in minimum intensity at which the stimulus become painful (pain threshold, PainT)
timeFrame: change from baseline to immediately after completing the training protocol, at 1 month follow up and at 3 months follow up
measure: Change in pain as measured by the McGill Pain Questionnaire (MPQ)
timeFrame: 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
measure: Change in neuropathic pain as measured by the Neuropathic Pain Symptom Inventory (NPSI)
timeFrame: 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:
measure: Change in ability to perceive various types of sensations as indicated by Quantitative Sensory Testing (QST)
timeFrame: 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
measure: Change in basic functional independence as measured by the Spinal Cord Independence Measure (SCIM III)
timeFrame: Completed at baseline, after completing 30 conditioning sessions, 1 month follow up, and 3 months follow up
measure: Change in functional independence as measured by the Functional Independence Measure (FIM)
timeFrame: Completed at baseline, after completing 30 conditioning sessions, 1 month follow up, and 3 months follow up
measure: Change in quality of life as measured by Spinal Cord Injury Quality of Life and Participation Questionnaire (SCI-QOL)
timeFrame: Completed at baseline, after completing 30 conditioning sessions, 1 month follow up, and 3 months follow up
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Aiko Thompson, PhD
role: PRINCIPAL_INVESTIGATOR
References: