Brain-Train Home Based Pain Treatment
Primary Purpose
Neuropathic Pain
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Neurofeedback training
Sponsored by
About this trial
This is an interventional treatment trial for Neuropathic Pain focused on measuring Spinal Cord Injury
Eligibility Criteria
Inclusion Criteria:
- normal or corrected to normal vision
- no history of brain disease or injury
- incomplete/complete injury at level C5 to T12
- central neuropathic pain (below the level of injury)
- intensity of pain 4 or above (VNS)
- stable medication regime (expected not to change during the period of the study), responding to some extent to CNP medication treatment
- patient or caregiver minimum computer literacy (owning a computer, laptop, tablet, ipad etc)
Exclusion Criteria:
- chronic or acute muscular or visceral pain larger than 4 VNS
- epilepsy
- diagnosed mental health problems
- active intervention of pain team (changing existing treatments)
Sites / Locations
- Queen Elizabeth National Spinal Injuries Unit
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Neurofeedback training
Arm Description
Neurofeedback training: self-administered at home for 3 months. 3-5 sessions per week initially, then at least once a week. Each session consists of 5-6 blocks of 5 minute training.
Outcomes
Primary Outcome Measures
Pain intensity
Change in intensity of pain as measured by the Visual Numerical Scale
Secondary Outcome Measures
Brain activity
Change in brain activity as measured by EEG
Patients' perspective of home-based neuro-therapy training
Qualitative assessment of patient's perspective of treatment as assessed by questionnaire and one-to-one semi-structured interview
Full Information
NCT ID
NCT02678494
First Posted
February 5, 2016
Last Updated
August 30, 2018
Sponsor
NHS Greater Glasgow and Clyde
1. Study Identification
Unique Protocol Identification Number
NCT02678494
Brief Title
Brain-Train Home Based Pain Treatment
Official Title
Home Based Brain-Train Treatment of Central Neuropathic Pain Following Spinal Cord Injury
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
June 9, 2016 (Actual)
Primary Completion Date
November 1, 2017 (Actual)
Study Completion Date
November 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NHS Greater Glasgow and Clyde
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A study examining the effectiveness of neurofeedback therapy for the treatment of Central Neuropathic Pain (CNP), in patients with a Spinal Cord Injury, using a small user-friendly device which can be operated by patients at home.
Detailed Description
Spinal Cord Injury (SCI) affects a person's ability to move and feel sensation from 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% to 40% of SCI patients, severe CNP affects their everyday living including sleep and mood. Medical treatment of CNP is moderately effective and costly, both to the patient and to the health care system.
In a previous study, some characteristic 'signatures' of brain waves that are related to CNP were 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 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. Costly laboratory devices were used and once the study was over, an adequate alternative could not be offered to patients.
In this study, a cheap, portable, wireless and user friendly, Conformité Européenne (CE) marked EEG device will be used to train 10 patients to self-administer the therapy in the comfort of their homes. Participants will be given initial training to use the equipment then will be asked to use the system at home for 3 months - initially, 3-5 times a week then, if/when pain subsides, at least once a week or as required.
The primary purpose of the study is to determine whether a portable system for neuromodulation is a useful tool for administering therapy for pain (intensity of pain will be measured by the visual numerical scale (VNS)).
The secondary purpose of the study is a quantitative analysis of changes in the brain activity due to therapy, as measured by EEG; patients' perspective of the home based neuro-therapy (assessed by questionnaires and one-to-one, semi-structured interviews).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain
Keywords
Spinal Cord Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Neurofeedback training
Arm Type
Experimental
Arm Description
Neurofeedback training: self-administered at home for 3 months. 3-5 sessions per week initially, then at least once a week. Each session consists of 5-6 blocks of 5 minute training.
Intervention Type
Other
Intervention Name(s)
Neurofeedback training
Primary Outcome Measure Information:
Title
Pain intensity
Description
Change in intensity of pain as measured by the Visual Numerical Scale
Time Frame
Baseline and 3 months
Secondary Outcome Measure Information:
Title
Brain activity
Description
Change in brain activity as measured by EEG
Time Frame
Baseline and 3 months
Title
Patients' perspective of home-based neuro-therapy training
Description
Qualitative assessment of patient's perspective of treatment as assessed by questionnaire and one-to-one semi-structured interview
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
normal or corrected to normal vision
no history of brain disease or injury
incomplete/complete injury at level C5 to T12
central neuropathic pain (below the level of injury)
intensity of pain 4 or above (VNS)
stable medication regime (expected not to change during the period of the study), responding to some extent to CNP medication treatment
patient or caregiver minimum computer literacy (owning a computer, laptop, tablet, ipad etc)
Exclusion Criteria:
chronic or acute muscular or visceral pain larger than 4 VNS
epilepsy
diagnosed mental health problems
active intervention of pain team (changing existing treatments)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aleksandra Vuckovic, Dipl Ing MSc PhD
Organizational Affiliation
University of Glasgow
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Elizabeth National Spinal Injuries Unit
City
Glasgow
Country
United Kingdom
12. IPD Sharing Statement
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Brain-Train Home Based Pain Treatment
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