Back to resultsNeuropathic Pain and Operant Conditioning of Cutaneous Reflexes After SCI
Primary Purpose
Spinal Cord Injuries, Neuropathic Pain, Neurological Injury
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Operant Conditioning of Cutaneous Reflexes
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Neuroplasticity
Eligibility Criteria
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.
Sites / Locations
- Medical University of South CarolinaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Operant Conditioning of Cutaneous Reflexes
Arm Description
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.
Outcomes
Primary Outcome Measures
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 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 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 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).
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).
Secondary Outcome Measures
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.
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.
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).
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
Full Information
NCT ID
NCT05492188
First Posted
August 5, 2022
Last Updated
April 3, 2023
Sponsor
Medical University of South Carolina
1. Study Identification
Unique Protocol Identification Number
NCT05492188
Brief Title
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
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 27, 2023 (Actual)
Primary Completion Date
October 1, 2025 (Anticipated)
Study Completion Date
October 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Neuropathic Pain, Neurological Injury, Pain
Keywords
Neuroplasticity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Operant Conditioning of Cutaneous Reflexes
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Operant Conditioning of Cutaneous Reflexes
Intervention Description
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 Information:
Title
Change in minimum stimulation intensity required to barely detect the sensation (perceived threshold, perT)
Description
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.
Time Frame
change from baseline to immediately after completing the training protocol, at 1 month follow up and at 3 months follow up
Title
Change in minimum intensity at which the sensation covers the maximum area of skin (radiating threshold, RT)
Description
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.
Time Frame
change from baseline to immediately after completing the training protocol, at 1 month follow up and at 3 months follow up
Title
Change in minimum intensity at which the stimulus become painful (pain threshold, PainT)
Description
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.
Time Frame
change from baseline to immediately after completing the training protocol, at 1 month follow up and at 3 months follow up
Title
Change in pain as measured by the McGill Pain Questionnaire (MPQ)
Description
The MPQ is a self-report questionnaire that assesses quality and intensity of pain. Scores range from 0 (no pain) to 78 (severe pain).
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
Title
Change in neuropathic pain as measured by the Neuropathic Pain Symptom Inventory (NPSI)
Description
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).
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
Secondary Outcome Measure Information:
Title
Change in ability to perceive various types of sensations as indicated by Quantitative Sensory Testing (QST)
Description
The QST is a battery of assessments that measure sensory thresholds for pain, touch, vibration, and hot and cold temperature sensations.
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
Title
Change in basic functional independence as measured by the Spinal Cord Independence Measure (SCIM III)
Description
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.
Time Frame
Completed at baseline, after completing 30 conditioning sessions, 1 month follow up, and 3 months follow up
Title
Change in functional independence as measured by the Functional Independence Measure (FIM)
Description
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).
Time Frame
Completed at baseline, after completing 30 conditioning sessions, 1 month follow up, and 3 months follow up
Title
Change in quality of life as measured by Spinal Cord Injury Quality of Life and Participation Questionnaire (SCI-QOL)
Description
An increase in score on the SCI-QOL indicates an increase in quality of life
Time Frame
Completed at baseline, after completing 30 conditioning sessions, 1 month follow up, and 3 months follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Blair Dellenbach, MSOT
Phone
843-792-6313
Email
stecb@musc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aiko Thompson, PhD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Blair Dellenbach, MSOT
Phone
843-792-6313
12. IPD Sharing Statement
Learn more about this trial
Neuropathic Pain and Operant Conditioning of Cutaneous Reflexes After SCI
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