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Status:

UNKNOWN

EEG Predictors of Neuropathic Pain in SCI

Lead Sponsor:

NHS Greater Glasgow and Clyde

Collaborating Sponsors:

Buckinghamshire Healthcare NHS Trust

Conditions:

Central Neuropathic Pain

Spinal Cord Injuries

Eligibility:

All Genders

18-80 years

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 develop...

Detailed Description

Study Design The proposed study will be a longitudinal cohort study in which participants will attend one assessment session as inpatients in the subacute stage and a further assessment six months lat...

Eligibility Criteria

Inclusion

  • Inclusion criteria for patients with SCI and NO chronic pain are as follows:
  • 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
  • Inclusion criteria for patients with SCI and CNP are as follows:
  • 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)
  • Inclusion criteria for able-bodied participants:
  • Age 18-80
  • No self-reported neurological conditions
  • No chronic or acute pain equal or larger than 3 on VNS
  • Normal or corrected to normal vision
  • English speaker

Exclusion

  • Exclusion criteria for patients with and without CNP:
  • 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
  • Able bodied people and people who had spinal cord injury and are still in subacute phase (6 monthExclusion Criteria for able-bodied participants:
  • Unable to give informed consent
  • Presence of chronic or acute pain equal to or larger than 3 on VNS
  • Any self-reported neurological conditions
  • Non-English Speaker s post injury)

Key Trial Info

Start Date :

January 15 2021

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

April 1 2023

Estimated Enrollment :

80 Patients enrolled

Trial Details

Trial ID

NCT04665492

Start Date

January 15 2021

End Date

April 1 2023

Last Update

December 16 2020

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Stoke Mandevill Hospital, National Spinal Injuries Unit

Stoke Mandeville, Buckinghamshire, United Kingdom, HP218AL

2

Queen Elizabeth University Hospital, Queen Elizabeth National Spinal Injurie Unit

Glasgow, United Kingdom, G514TF