Status:
COMPLETED
Axon - Brain Train for Pain
Lead Sponsor:
Exsurgo Rehab Limited
Collaborating Sponsors:
East Midlands Spine Ltd
PhysioFunction Ltd
Conditions:
Chronic Pain
Depression, Anxiety
Eligibility:
All Genders
18-65 years
Phase:
NA
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-pharmacologica...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 28 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04418362
Start Date
June 16 2020
End Date
July 28 2021
Last Update
March 23 2022
Active Locations (1)
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1
East Midlands Spine Ltd
Northampton, United Kingdom