Ignite Creation Date:
2024-05-06 @ 8:08 AM
Last Modification Date:
2024-10-26 @ 11:56 AM
Study NCT ID:
NCT02678494
Status:
COMPLETED
Last Update Posted:
2018-09-04
First Post:
2016-02-05
Brief Title:
Brain-Train Home Based Pain Treatment
Sponsor:
NHS Greater Glasgow and Clyde
Organization:
NHS Greater Glasgow and Clyde
Study Overview
Official Title:
Home Based Brain-Train Treatment of Central Neuropathic Pain Following Spinal Cord Injury
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 persons 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 eg 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 ifwhen 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
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 eg 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 ifwhen 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None