Clinical trial NCT04418362: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Depression, Anxiety
Sleep
Quality of Life
Lead sponsor: Exsurgo Rehab Limited
Sponsor class: INDUSTRY
Collaborators: name: East Midlands Spine Ltd
name: PhysioFunction Ltd
First posted: 2020-06-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group assignment
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in pain intensity as measured by the VNS (Visual Numerical Scale)
timeFrame: Pre-intervention, before and after each training session over 8 week period, and 1, 3 and 6 months after final training session
Secondary outcomes:
measure: Change in mood as measured by Hospital Anxiety and Depression Scale (HADS)
timeFrame: Pre-intervention, after the final training session (8 weeks), and 1, 3 and 6 months after final session
measure: Change in quality of sleep as measured by the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Pre-intervention, after the final training session (8 weeks), and 1, 3 and 6 months after final session
measure: Change in quality of life components as measured by the EQ-5D-5L
timeFrame: Pre-intervention, after the final training session (8 weeks), and 1, 3 and 6 months after final session
measure: Changes in EEG activity
timeFrame: Baseline (eyes open and eyes closed) pre-intervention, and before and after each training session over 8 weeks
measure: Experience of chronic pain and neurofeedback training
timeFrame: Post-intervention - after final training session (8 weeks)
Other outcomes:
Locations:
city: Northampton
country: United Kingdom
facility: East Midlands Spine Ltd
Study officials:
affiliation: East Midlands Spine Ltd
name: Nicholas Birch
role: PRINCIPAL_INVESTIGATOR
References:
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.