Axon - Brain Train for Pain
Primary Purpose
Chronic Pain, Depression, Anxiety, Sleep
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 Chronic Pain
Eligibility Criteria
Inclusion Criteria:
- Head circumference range (560 - 595 mm)
- Patients suffering from chronic pain (mean VNS >4) for at least 6 months.
- Chronic pain from any neurological or musculoskeletal cause, of which examples could be, post herpetic (or post-shingles) neuralgia, complex regional pain syndrome (CRPS), lower back pain, neck pain, major joint pain, spinal cord injury, phantom limb pain, brachial plexus injury related pain, traumatic peripheral nerve injury pain and post-cancer treatment pain
- Stable medication and treatment over the intervention period
- Participant or caregiver with minimum computer literacy able to effectively operate equipment after training, and the ability to position and remove headset effectively for training sessions
Exclusion Criteria:
- Patients who do not meet inclusion criteria (above)
- Failing pre-screening suitability criteria for neurofeedback due to a neurological disorder, psychiatric disorder, epilepsy, regular use of benzodiazepines, previous neurofeedback training, serious head injury and other medication that has contraindications for neurofeedback training
- Dreadlocks, braids, beads, or any other hairstyle or hair covering that cannot be removed for training
- Known or suspected pregnancy
- Diagnosis of (or currently undergoing treatment for) cancer, systemic infection, severe cardiovascular/respiratory comorbidity
- Implanted electronic neuromodulation device
- Implanted pacemaker or loop recorder
- Any change in medication or treatment planned during the intervention period
- Inability to use the equipment due to severity of pain
Sites / Locations
- East Midlands Spine Ltd
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Neurofeedback training
Arm Description
Neurofeedback training: self-administered at home 4-6 times per week for 8 weeks. Each session consists of 6 blocks of 5 minute training with a one minute rest period between each block.
Outcomes
Primary Outcome Measures
Change in pain intensity as measured by the VNS (Visual Numerical Scale)
Ordinal measurement of individual's pain intensity
Secondary Outcome Measures
Change in mood as measured by Hospital Anxiety and Depression Scale (HADS)
Rating scale (self-administered)
Change in quality of sleep as measured by the Pittsburgh Sleep Quality Index (PSQI)
A self-report questionnaire assessing sleep quality
Change in quality of life components as measured by the EQ-5D-5L
A self-assessed, health related, quality of life questionnaire.
Changes in EEG activity
Changes in relative Alpha, Theta and Beta ratio, as measured by EEG
Experience of chronic pain and neurofeedback training
Qualitative interviews of the lived experience of taking part in neurofeedback training for chronic pain
Full Information
NCT ID
NCT04418362
First Posted
May 29, 2020
Last Updated
March 21, 2022
Sponsor
Exsurgo Rehab Limited
Collaborators
East Midlands Spine Ltd, PhysioFunction Ltd
1. Study Identification
Unique Protocol Identification Number
NCT04418362
Brief Title
Axon - Brain Train for Pain
Official Title
Axon - Brain Train for Pain - A Home-based Neurofeedback Intervention to Treat the Primary and Secondary Symptoms of Chronic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
June 16, 2020 (Actual)
Primary Completion Date
January 31, 2021 (Actual)
Study Completion Date
July 28, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Exsurgo Rehab Limited
Collaborators
East Midlands Spine Ltd, PhysioFunction Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A mixed methods proof of concept study to ascertain the effectiveness of a home-based self-administered neurofeedback intervention to treat the primary and secondary symptoms of chronic pain.
Detailed Description
In order to address the growing problem of chronic pain management in the UK, a proof of concept/feasibility open label study has been devised to test a home-based self-administered non-pharmacological treatment utilising neurofeedback training with a headset and tablet-based software application.
This study will include individuals suffering from various types of chronic pain, measuring changes in pain intensity alongside associated symptoms (depression, anxiety, sleep, and quality of life) by utilising a purpose-built software application and headset that is easy to use and structurally robust.
Twenty participants will take part in pre-intervention quantitative assessments measuring the primary and secondary symptoms of chronic pain. This will be followed by one-to-one remote training where they will be provided with detailed instructions on how to self-administer the neurofeedback training in the comfort of their own homes. They will then take part in 4-6 training sessions per week over an 8-week period.
Post- intervention quantitative assessments will be conducted alongside a qualitative analysis of the experience of doing neurofeedback training for chronic pain. Participant feedback on how the protocol, equipment and research could be improved will also be recorded to inform further research.
Participants will also take part in online follow-up assessments at 1, 3, and 6 months after the intervention. Any adjustments to pain medication will also be recorded over this period. It is anticipated this study will provide initial evidence of the safety, efficacy, reliability and validity of a low-cost non-pharmacological solution to the physical, psychological and social difficulties experienced by individuals with chronic pain, with a view to a larger subsequent multisite trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Depression, Anxiety, Sleep, Quality of Life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single group assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Neurofeedback training
Arm Type
Experimental
Arm Description
Neurofeedback training: self-administered at home 4-6 times per week for 8 weeks. Each session consists of 6 blocks of 5 minute training with a one minute rest period between each block.
Intervention Type
Other
Intervention Name(s)
Neurofeedback training
Intervention Description
A home-based self-administered neurofeedback intervention taking place 4-6 times per week for 8 weeks.
Primary Outcome Measure Information:
Title
Change in pain intensity as measured by the VNS (Visual Numerical Scale)
Description
Ordinal measurement of individual's pain intensity
Time Frame
Pre-intervention, before and after each training session over 8 week period, and 1, 3 and 6 months after final training session
Secondary Outcome Measure Information:
Title
Change in mood as measured by Hospital Anxiety and Depression Scale (HADS)
Description
Rating scale (self-administered)
Time Frame
Pre-intervention, after the final training session (8 weeks), and 1, 3 and 6 months after final session
Title
Change in quality of sleep as measured by the Pittsburgh Sleep Quality Index (PSQI)
Description
A self-report questionnaire assessing sleep quality
Time Frame
Pre-intervention, after the final training session (8 weeks), and 1, 3 and 6 months after final session
Title
Change in quality of life components as measured by the EQ-5D-5L
Description
A self-assessed, health related, quality of life questionnaire.
Time Frame
Pre-intervention, after the final training session (8 weeks), and 1, 3 and 6 months after final session
Title
Changes in EEG activity
Description
Changes in relative Alpha, Theta and Beta ratio, as measured by EEG
Time Frame
Baseline (eyes open and eyes closed) pre-intervention, and before and after each training session over 8 weeks
Title
Experience of chronic pain and neurofeedback training
Description
Qualitative interviews of the lived experience of taking part in neurofeedback training for chronic pain
Time Frame
Post-intervention - after final training session (8 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Head circumference range (560 - 595 mm)
Patients suffering from chronic pain (mean VNS >4) for at least 6 months.
Chronic pain from any neurological or musculoskeletal cause, of which examples could be, post herpetic (or post-shingles) neuralgia, complex regional pain syndrome (CRPS), lower back pain, neck pain, major joint pain, spinal cord injury, phantom limb pain, brachial plexus injury related pain, traumatic peripheral nerve injury pain and post-cancer treatment pain
Stable medication and treatment over the intervention period
Participant or caregiver with minimum computer literacy able to effectively operate equipment after training, and the ability to position and remove headset effectively for training sessions
Exclusion Criteria:
Patients who do not meet inclusion criteria (above)
Failing pre-screening suitability criteria for neurofeedback due to a neurological disorder, psychiatric disorder, epilepsy, regular use of benzodiazepines, previous neurofeedback training, serious head injury and other medication that has contraindications for neurofeedback training
Dreadlocks, braids, beads, or any other hairstyle or hair covering that cannot be removed for training
Known or suspected pregnancy
Diagnosis of (or currently undergoing treatment for) cancer, systemic infection, severe cardiovascular/respiratory comorbidity
Implanted electronic neuromodulation device
Implanted pacemaker or loop recorder
Any change in medication or treatment planned during the intervention period
Inability to use the equipment due to severity of pain
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas Birch
Organizational Affiliation
East Midlands Spine Ltd
Official's Role
Principal Investigator
Facility Information:
Facility Name
East Midlands Spine Ltd
City
Northampton
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35712448
Citation
Birch N, Graham J, Ozolins C, Kumarasinghe K, Almesfer F. Home-Based EEG Neurofeedback Intervention for the Management of Chronic Pain. Front Pain Res (Lausanne). 2022 May 27;3:855493. doi: 10.3389/fpain.2022.855493. eCollection 2022.
Results Reference
derived
Learn more about this trial
Axon - Brain Train for Pain
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