EEG Predictors of Neuropathic Pain in SCI

NCT04665492 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2020-12-16

No results posted yet for this study

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.

Conditions

  • Central Neuropathic Pain
  • Spinal Cord Injuries

Interventions

DIAGNOSTIC_TEST

EEG recording 1

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.

DIAGNOSTIC_TEST

EEG recording 2

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.

DIAGNOSTIC_TEST

Sensory Test

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

DIAGNOSTIC_TEST

Brief Pain Inventory 1

This questionnaire that ask about any acute or chronic pain

DIAGNOSTIC_TEST

Multidimensional health locus of control

Questionnaire that test personal belief about control of one's own health

DIAGNOSTIC_TEST

Sensory test thermal

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

DIAGNOSTIC_TEST

Neuropathic pain symptoms

Questionnaire that test for neuropathic pain symptoms

DIAGNOSTIC_TEST

McGill pain questionnaire

Questionnaire assess three separate components of experiencing pain; the sensory intensity, the emotional impact and the cognitive evaluation of pain.

DIAGNOSTIC_TEST

Pain Catastrophising Scale

Questionnaire use to identify individual pain experience.

Sponsors & Collaborators

  • Buckinghamshire Healthcare NHS Trust

    collaborator OTHER
  • NHS Greater Glasgow and Clyde

    lead OTHER

Principal Investigators

  • Aleksandra Vuckovic · University of Glasgow

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-15
Primary Completion
2022-11-01
Completion
2023-04-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04665492 on ClinicalTrials.gov