EEG Predictors of Neuropathic Pain in SCI
Electroencephalographic Predictors of Central Neuropathic Pain in Subacute Spinal Cord Injury
2 other identifiers
observational
80
1 country
2
Brief Summary
Spinal cord injury (SCI), induced by damage to the spinal cord, can cause life-altering levels of disability including the development of chronic pain. Central Neuropathic Pain (CNP) typically develops within months after injury in 40-50% of SCI patients, affecting everyday activity, sleep and mood. There is no cure for CNP, it can be very difficult to treat and is often refractory to any pharmacological treatments. In a previous study (study no. 14/WS/1029) the principle investigators showed that the likelihood of CNP developing can be predicted by defining characteristics of brain waves that are related to pain. We will use electroencephalograph (EEG) to measure brain activity in people early after SCI, before they develop pain, knowing that about half will develop pain within a year. We aim to recruit 80 participants, aged 18-80; 40 with subacute spinal injury (level C3-T12) and no symptoms of CNP; 20 with symptoms of CNP and 20 able-bodied participants. Completeness of injury is irrelevant. Patients will be recruited by clinical consultants within national spinal units in Glasgow and Stoke Mandeville. Patients will undergo two EEG recording sessions in which they will imagine movements while we record EEG. Sessions will also involve basic sensory testing and completion of questionnaires. Able-bodied participants will be recruited by the Philosophy Doctor (PhD) candidate at the University of Glasgow and undergo only one EEG session (identical to SCI patients). The primary aim of this study is to use early EEG markers of CNP to optimise and validate an existing computer program based on machine learning to enable more accurate prediction of pain in newly injured patients with the hope of aiding future treatments. Secondary aims include characterising EEG features which might describe different phases in patients' development of CNP and exploring possible differences between pain at/below the level of SCI based on EEG markers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2021
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 16, 2020
CompletedFirst Posted
Study publicly available on registry
December 11, 2020
CompletedStudy Start
First participant enrolled
January 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2023
CompletedDecember 16, 2020
November 1, 2020
1.8 years
November 16, 2020
December 14, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
EEG based classifier of pain
Create a software application that can classifify between people with SCI and healthy people and people with SCI with and without pain based on EEG markers
All groups EEG recording upon recruitment
Changes in EEG
Difference between baseline EEG and EEG recorded six months later
EEG recording upon recruitment and EEG recording six month later in all groups of people with SCI
Secondary Outcomes (3)
EEG markers of different phased of SCI
Fist EEG recording upon recruitment, second six month later
EEG markers of at level and below level pain
Fist EEG recording upon recruitment, second six month later
Correlation between sensory and neurological test and questionnaires
Fist EEG recording, sensory test and questionnaires uppon recruitment, second six month later
Study Arms (3)
SCI with CNP
People with subacute spinal cord injury and no chronic pain
SCI no CNP
People with subacute spinal cord injury with central neuropathic pain
Able bodied
Able bodied people with no chronic pain
Interventions
Multichannel EEG recording in eyes opened and eyes closed relaxed state and during imagined movement (all one experimental session). EEG device "usbamp" (company "Guger Technologies", Austria) will be used.
Multichannel EEG recording in eyes opened and eyes closed relaxed state and during imagined movement (all one experimental session). This intervention will take place six month after EEG recording 1. EEG device "usbamp" (company "Guger Technologies", Austria) will be used.
Test for mechanical sensations of the feet and shins of both legs as well as on the trapezoidal muscle on both sides. Semmes-Weinstein Monofilaments will be used
This questionnaire that ask about any acute or chronic pain
Questionnaire that test personal belief about control of one's own health
Test of thermal sensations (thermal roller) of the feet and shins of both legs as well as on the trapezoidal muscle on both sides. A "Somedic SenseLab Rolltemp" device will be used
Questionnaire that test for neuropathic pain symptoms
Questionnaire assess three separate components of experiencing pain; the sensory intensity, the emotional impact and the cognitive evaluation of pain.
Questionnaire use to identify individual pain experience.
Eligibility Criteria
Able bodied people and people with subacute spinal cord injury
You may qualify if:
- Age between 18-80
- Subacute spinal cord injury (within 6 months post injury)
- Level C3-T12
- ASIA A, B, C or D
- Normal or corrected to normal vision
- No allodynia or hyperalgesia
- Age between 18-80
- Subacute spinal cord injury (within 6 months of injury)
- Level C3-T12
- ASIA A, B, C or D
- Normal or corrected to normal vision
- Presence of allodynia or hyperalgesia
- Diagnosed CNP related to SCI equal or larger than 4 on visual numerical scale (VNS)
- Age 18-80
- No self-reported neurological conditions
- +3 more criteria
You may not qualify if:
- Inability to understand the task
- Inability to sit for at least 2 hours (duration of EEG assessment)
- Invasive 24/7 ventilation
- Previously confirmed brain injury, (peripheral nerve injury and brachial plexus injury)
- Other self-reported neurological condition that would affect EEG recording
- Presence/history of any other chronic or acute pain (larger or equal to 3 on the VNS)
- Pressure sores or any other condition that might prevent sitting for 2 hours
- Halos or neck support that prevent EEG recording
- Infections of the skin or communicable diseases (e.g. hospital bugs)
- Concurrent acute medical problems (e.g. infections)
- Infection control issues i.e. the need for patient isolation
- Do not understand English
- Unable to give informed consent
- Presence of chronic or acute pain equal to or larger than 3 on VNS
- Any self-reported neurological conditions
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Stoke Mandevill Hospital, National Spinal Injuries Unit
Stoke Mandeville, Buckinghamshire, HP218AL, United Kingdom
Queen Elizabeth University Hospital, Queen Elizabeth National Spinal Injurie Unit
Glasgow, G514TF, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Aleksandra Vuckovic
University of Glasgow
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 16, 2020
First Posted
December 11, 2020
Study Start
January 15, 2021
Primary Completion
November 1, 2022
Study Completion
April 1, 2023
Last Updated
December 16, 2020
Record last verified: 2020-11