Chronic PainNCT04418362
Axon - Brain Train for Pain
A study testing Neurofeedback training in people with Chronic Pain and Depression, Anxiety, run by Exsurgo Rehab Limited at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Pain, Depression, Anxiety, Sleep
- What is being tested?
- Neurofeedback training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Jun 2020to 28 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Axon - Brain Train for Pain - A Home-based Neurofeedback Intervention to Treat the Primary and Secondary Symptoms of Chronic Pain
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.
Read the 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.
- Conditions
- Chronic Pain, Depression, Anxiety, Sleep, Quality of Life
- Being tested
- Neurofeedback training
- Medical subject headings
- Chronic Pain, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurofeedback trainingOther
A home-based self-administered neurofeedback intervention taking place 4-6 times per week for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Neurofeedback training | Experimental | 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. Receives: Other: Neurofeedback training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity as measured by the VNS (Visual Numerical Scale)
Ordinal measurement of individual's pain intensity
Measured: Pre-intervention, before and after each training session over 8 week period, and 1, 3 and 6 months after final training session
Secondary outcomes (5)
Change in mood as measured by Hospital Anxiety and Depression Scale (HADS)
Rating scale (self-administered)
Measured: Pre-intervention, after the final training session (8 weeks), and 1, 3 and 6 months after final session
Change in quality of sleep as measured by the Pittsburgh Sleep Quality Index (PSQI)
A self-report questionnaire assessing sleep quality
Measured: Pre-intervention, after the final training session (8 weeks), and 1, 3 and 6 months after final session
Change in quality of life components as measured by the EQ-5D-5L
A self-assessed, health related, quality of life questionnaire.
Measured: Pre-intervention, after the final training session (8 weeks), and 1, 3 and 6 months after final session
Changes in EEG activity
Changes in relative Alpha, Theta and Beta ratio, as measured by EEG
Measured: Baseline (eyes open and eyes closed) pre-intervention, and before and after each training session over 8 weeks
Experience of chronic pain and neurofeedback training
Qualitative interviews of the lived experience of taking part in neurofeedback training for chronic pain
Measured: Post-intervention - after final training session (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start16 Jun 2020
- Primary completion31 Jan 2021
- Study completion28 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group assignment
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Exsurgo Rehab Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- East Midlands Spine Ltd, PhysioFunction Ltd
- Responsible party
- Sponsor
- Investigators
- Nicholas Birch, Principal investigator, East Midlands Spine Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04418362
- Sponsor's protocol ID
- ED1001033
- Status last verified
- Jul 2020
- First submitted
- 29 May 2020
- Last updated
- 23 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35712448
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Axon - Brain Train for Pain - A Home-based Neurofeedback Intervention to Treat the Primary and Secondary Symptoms of Chronic Pain
- ClinicalTrials.gov ID
- NCT04418362
- Acronym / sponsor ID
- ED1001033
- Conditions
- Chronic Pain, Depression, Anxiety, Sleep, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Exsurgo Rehab LimitedIndustry (pharma, biotech, devices)
- Collaborators
- East Midlands Spine Ltd, PhysioFunction Ltd
- Study start
- 16 Jun 2020 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 28 Jul 2021 (actual)
- First posted
- 5 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group assignment
| Arm | Type | Receives |
|---|---|---|
| Neurofeedback training | Experimental | Other: Neurofeedback trainingNeurofeedback 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurofeedback trainingA home-based self-administered neurofeedback intervention taking place 4-6 times per week for 8 weeks. | Other | Neurofeedback training |
Primary outcome
Change in pain intensity as measured by the VNS (Visual Numerical Scale)
Time frame: Pre-intervention, before and after each training session over 8 week period, and 1, 3 and 6 months after final training session
Ordinal measurement of individual's pain intensity
5 secondary outcomes
Change in mood as measured by Hospital Anxiety and Depression Scale (HADS)
Time frame: Pre-intervention, after the final training session (8 weeks), and 1, 3 and 6 months after final session
Change in quality of sleep as measured by the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Pre-intervention, after the final training session (8 weeks), and 1, 3 and 6 months after final session
Change in quality of life components as measured by the EQ-5D-5L
Time frame: Pre-intervention, after the final training session (8 weeks), and 1, 3 and 6 months after final session
Changes in EEG activity
Time frame: Baseline (eyes open and eyes closed) pre-intervention, and before and after each training session over 8 weeks
Experience of chronic pain and neurofeedback training
Time frame: Post-intervention - after final training session (8 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
- Derived from this study: PubMed 35712448Birch 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas Birch principal investigator
East Midlands Spine Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurofeedback training in people with Chronic Pain and Depression, Anxiety, run by Exsurgo Rehab Limited at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity as measured by the VNS (Visual Numerical Scale) (time frame: Pre-intervention, before and after each training session over 8 week period, and 1, 3 and 6 months after final training session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04418362, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2022.