Axon - Brain Train for Pain

Quality of Life Clinical Trial

Official title:

Axon - Brain Train for Pain - A Home-based Neurofeedback Intervention to Treat the Primary and Secondary Symptoms of Chronic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04418362
• Other study ID #: ED1001033
• Status: Completed
• Phase: N/A
• Start date: June 16, 2020
• Est. completion date: July 28, 2021

Study information

• Verified date: July 2020
• Source: Exsurgo Rehab Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 28, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Depression, Anxiety
• Quality of Life
• Sleep

Intervention

Other:
• Neurofeedback training
A home-based self-administered neurofeedback intervention taking place 4-6 times per week for 8 weeks.

Locations

Country	Name	City	State
United Kingdom	East Midlands Spine Ltd	Northampton

Sponsors (3)

Lead Sponsor	Collaborator
Exsurgo Rehab Limited	East Midlands Spine Ltd, PhysioFunction Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain intensity as measured by the VNS (Visual Numerical Scale)	Ordinal measurement of individual's pain intensity	Pre-intervention, before and after each training session over 8 week period, and 1, 3 and 6 months after final training session
Secondary	Change in mood as measured by Hospital Anxiety and Depression Scale (HADS)	Rating scale (self-administered)	Pre-intervention, after the final training session (8 weeks), and 1, 3 and 6 months after final session
Secondary	Change in quality of sleep as measured by the Pittsburgh Sleep Quality Index (PSQI)	A self-report questionnaire assessing sleep quality	Pre-intervention, after the final training session (8 weeks), and 1, 3 and 6 months after final session
Secondary	Change in quality of life components as measured by the EQ-5D-5L	A self-assessed, health related, quality of life questionnaire.	Pre-intervention, after the final training session (8 weeks), and 1, 3 and 6 months after final session
Secondary	Changes in EEG activity	Changes in relative Alpha, Theta and Beta ratio, as measured by EEG	Baseline (eyes open and eyes closed) pre-intervention, and before and after each training session over 8 weeks
Secondary	Experience of chronic pain and neurofeedback training	Qualitative interviews of the lived experience of taking part in neurofeedback training for chronic pain	Post-intervention - after final training session (8 weeks)