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

Primary Purpose

Spinal Cord Injury

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Neurofeedback therapy
No neurofeedback therapy
Sponsored by
NHS Greater Glasgow and Clyde
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with Central Neuropathic Pain (Treatment and Control Groups)

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

Patients with no chronic pain

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

Exclusion Criteria:

Patients with Central Neuropathic Pain (Control and Treatment Groups)

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

Patients with no chronic pain

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

Sites / Locations

  • Queen Elizabeth National Spinal Injuries Unit, Southern General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

No Intervention

Arm Label

patients with central neuropathic pain

Control: patients with central neuropathic pain

patients with no central neuropathic pain

Arm Description

Randomised to 20 neurofeedback therapy sessions

Randomised to no neurofeedback treatment

Observed for development of central neuropathic pain

Outcomes

Primary Outcome Measures

Intensity of Pain
As measured by a numerical analogue scale

Secondary Outcome Measures

Changes in EEG activity
Changes in Spasticity
Modified Ashworth Scale and patellar reflex
Changes in Mood
Changes in quality of sleep
Medical Outcomes Study (MOS) Sleep Scale

Full Information

First Posted
June 27, 2014
Last Updated
February 27, 2019
Sponsor
NHS Greater Glasgow and Clyde
Collaborators
University of Glasgow
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1. Study Identification

Unique Protocol Identification Number
NCT02178917
Brief Title
Neurofeedback for Treatment of Central Neuropathic Pain (CNP) in Sub-acute Spinal Cord Injury (SCI)
Official Title
Neurofeedback Treatment of Central Neuropathic Pain (CNP) in Sub-acute Patients With Spinal Cord Injury (SCI)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
August 27, 2014 (Actual)
Primary Completion Date
November 29, 2017 (Actual)
Study Completion Date
November 29, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NHS Greater Glasgow and Clyde
Collaborators
University of Glasgow

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients with central neuropathic pain
Arm Type
Experimental
Arm Description
Randomised to 20 neurofeedback therapy sessions
Arm Title
Control: patients with central neuropathic pain
Arm Type
Other
Arm Description
Randomised to no neurofeedback treatment
Arm Title
patients with no central neuropathic pain
Arm Type
No Intervention
Arm Description
Observed for development of central neuropathic pain
Intervention Type
Other
Intervention Name(s)
Neurofeedback therapy
Intervention Type
Other
Intervention Name(s)
No neurofeedback therapy
Primary Outcome Measure Information:
Title
Intensity of Pain
Description
As measured by a numerical analogue scale
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Changes in EEG activity
Time Frame
1 year
Title
Changes in Spasticity
Description
Modified Ashworth Scale and patellar reflex
Time Frame
1 year
Title
Changes in Mood
Time Frame
1 year
Title
Changes in quality of sleep
Description
Medical Outcomes Study (MOS) Sleep Scale
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Queen Elizabeth National Spinal Injuries Unit, Southern General Hospital
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
29751110
Citation
Vuckovic A, Jajrees M, Purcell M, Berry H, Fraser M. Electroencephalographic Predictors of Neuropathic Pain in Subacute Spinal Cord Injury. J Pain. 2018 Nov;19(11):1256.e1-1256.e17. doi: 10.1016/j.jpain.2018.04.011. Epub 2018 May 8.
Results Reference
derived

Learn more about this trial

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

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