Status:
UNKNOWN
Brain Activity in People With Chronic Neuropathic Pain and Spinal Cord Injury
Lead Sponsor:
Kessler Foundation
Collaborating Sponsors:
University of Surrey
Conditions:
Neuropathic Pain
Spinal Cord Injury
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
The purpose of this research study is to learn more about how patterns of brain activity change during different thinking tasks and how these changes relate to the intensity and unpleasantness of the ...
Detailed Description
Neuropathic pain is a kind of pain that is caused by a disruption of the nervous system. Neuropathic pain is common among people with spinal cord injury (SCI), is often severe, and can interfere signi...
Eligibility Criteria
Inclusion
- Age 18 or over
- Right-handed
- Complete or incomplete chronic (\>1 year) SCI classified as having a neurological level of C4 or below
- Chronic (≥3 month history) at- or below-level neuropathic pain
- Neuropathic pain of moderate or greater intensity (average intensity over the last week of ≥4 on an 11-point Numeric Rating Scale (NRS), where 0 = "no pain" and 10 = "worst pain imaginable")
- Neuropathic pain that is constant (present 7 days/week, 24 hours/day)
- Using a stable pain treatment regimen (not actively in process of starting a new pain treatment or changing dosage of an existing treatment)
- Able to understand verbal and written English
- Able and willing to comply with the study protocol, including availability for scheduled study procedures
Exclusion
- Current non-neuropathic pain of severe intensity (average intensity over the last week of ≥7 on an 11-point NRS, where 0 = "no pain" and 10 = "worst pain imaginable")
- SCI due to malignancy
- Cognitive impairment that could interfere with learning (Mini-Mental State Exam score of \<24)
- Current sacral, coccyx, or heel pressure injury
- Claustrophobia or fear of confined spaces
- Presence of any non-MRI compatible material in the body such as pacemakers or other implanted electrical devices, brain stimulators, particular types of dental implants, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves, and internal hearing aids \[cochlear implants\]), permanent eyeliner, implanted delivery pumps, or shrapnel fragments
- If female, currently pregnant
- Required use of non-MRI-compatible orthoses or devices (braces, ventilators, etc.)
- Current or past history of work as a welder or metal worker (because of possible small metal fragments in the eye of which they may be unaware)
- Inability to tolerate a supine position
- History (via self-report) of significant, uncontrollable spasticity while lying in supine position
- Progressive conditions that impact physical or cognitive functioning (metastatic cancer, multiple sclerosis, Parkinson Disease, Alzheimer's disease, etc.)
- History of traumatic brain injury
- Diagnosis of a psychiatric disorder such as post-traumatic stress disorder, schizophrenia or bipolar disorder
- History of substance abuse in the past six months
- Lack of intact sensation in the anterior shoulder (where stimuli will be applied during study procedures)
- Any other condition that would, in the opinion of the investigators, pose increased risk to the subject or affect the quality of data collected
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04386174
Start Date
August 1 2020
End Date
July 1 2022
Last Update
November 12 2021
Active Locations (1)
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1
Kessler Foundation
West Orange, New Jersey, United States, 07052