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Completed

NCT Number: NCT02178917

Neurofeedback for Treatment of Central Neuropathic Pain (CNP) in Sub-acute Spinal Cord Injury (SCI)

Spinal Cord Injury (SCI) affects a person's ability to move and feel sensation in the body. SCI is also an indirect cause of a persistent pain, called Central Neuropathic Pain (CNP). This pain typically develops several months after the injury. In 30-40% of SCI patients, severe CNP affects their everyday living including sleep and mood. Many patients give up work, not because of the injury, but because of pain. Medical treatment of CNP is moderately effective and costly, both to the patient and to the health care system.

In previous research, characteristic 'signatures' of brain waves that are probably related to CNP have been defined. Based on this, a novel treatment for CNP based on neurofeedback was developed and clinically tested on five SCI patients. Electroencephalograph (EEG) was used to record patients' brain waves and these were shown to patients on a computer screen in a simple graphical form (e.g. bars). Patients were trained to change their brain activity at will and, as a consequence, their pain was reduced. Patients who had suffered from CNP for years received up to 40 neurofeedback treatment sessions, reducing their pain for several days after each session.

The primary aim of this study is to apply neurofeedback therapy to a larger number of recently injured patients, who are still in a hospital. It is hypothesised that neurofeedback treatment will be more effective in people who have suffered from CNP for a shorter period of time.

The secondary aim of the study is to define EEG predictors of CNP. EEG will be recorded in recently injured patients with no chronic pain, knowing that a certain number of patients will develop CNP within weeks or months. These patients will be followed up for a year and the EEGs of patients who develop CNP will be compared with those who do not.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Elizabeth National Spinal Injuries Unit, Southern General Hospital

Glasgow, G51 4TF, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with Central Neuropathic Pain (Treatment and Control Groups)

  • Normal or corrected to normal vision
  • No history of brain disease or injury
  • Incomplete/complete spinal cord injury at level C5 to T12
  • Below level neuropathic pain for at least 6 weeks
  • Intensity of pain 4 or above (verbal numeric scale - VNS)
  • Stable medication regime responding to some extent to CNP medication treatment

Patients with no chronic pain

  • Normal or corrected to normal vision
  • No history of brain disease or injury
  • Incomplete/complete injury at level C5 to T12
  • Within 23 months post-injury

Exclusion criteria

Patients with Central Neuropathic Pain (Control and Treatment Groups)

  • Chronic or acute muscular or visceral pain larger than 4 VNS.
  • Epilepsy
  • Diagnosed mental health problems
  • Active intervention of pain team

Patients with no chronic pain

  • Chronic or acute pain larger than 3 on the VNS.
  • Epilepsy
  • Diagnosed mental health problems

Treatment and study plan

Neurofeedback therapy

Other

No neurofeedback therapy

Other

Primary outcomes

  1. Intensity of Pain

    Time frame: 1 year

    As measured by a numerical analogue scale

Secondary outcomes

  1. Changes in EEG activity

    Time frame: 1 year

  2. Changes in Spasticity

    Time frame: 1 year

    Modified Ashworth Scale and patellar reflex

  3. Changes in Mood

    Time frame: 1 year

  4. Changes in quality of sleep

    Time frame: 1 year

    Medical Outcomes Study (MOS) Sleep Scale

Sponsors and collaborators

Lead sponsor

NHS Greater Glasgow and Clyde

Other

Collaborators

  • University of Glasgow

Registry information

Official study title

Neurofeedback Treatment of Central Neuropathic Pain (CNP) in Sub-acute Patients With Spinal Cord Injury (SCI)

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jul 1, 2014
Registry last updated
Mar 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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