Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05464199 |
| Other study ID # |
2022/NEURO/02 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 1
|
| First received |
|
| Last updated |
|
| Start date |
October 6, 2022 |
| Est. completion date |
August 16, 2023 |
Study information
| Verified date |
September 2023 |
| Source |
East Kent Hospitals University NHS Foundation Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
In order to address the growing problem of chronic pain management in the UK, a proof of
concept/feasibility open label cohort study has been devised to explore the effectiveness of
a home-based self-administered non-pharmacological treatment utilising neurofeedback (NFB)
training with a headset and tablet-based software application. This study will replicate the
intervention from a previous clinical trial conducted in the UK during the Covid-19 lockdown
in 2020/21 (NCT04418362) and extend it by examining EEG activity before, during, and after
the intervention, alongside outcome measures, including changes in pain intensity and
severity, sleep, mood and quality of life.
Ten participants will take part in pre-intervention assessments followed by four weeks of EEG
baseline readings (5 times per week for 5 minutes), eight weeks of NFB treatment (5 times per
week for 40 mins), and 12 weeks of post treatment EEG baselines readings (5 times per week
for 5 minutes). Participants will be provided with training and detailed instructions on how
to self-administer the NFB treatment using a bespoke headset and tablet-based software
application in the comfort of their own homes.
Assessments will be conducted at Week 0 (pre-intervention), Week 4 (pre-NFB treatment), Week
12 (post NFB treatment) and at follow up points (Week 16, 20, and 24). It is anticipated this
study will provide 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 neuropathic pain conducted within the NHS health
system.
Description:
This research trial aims to explore the feasibility, safety and effectiveness of an 8-week
home-based EEG neurofeedback training programme for a sample of 10 individuals living with
severe chronic neuropathic pain within the NHS treatment framework.
Neurofeedback training aims to modulate brain EEG activity arising from cortical and
sub-cortical areas of the brain associated with pain perception and modulation, and
preliminary findings suggest it could be a safe and effective tool in the treatment of
chronic pain.
Several studies indicate that neurofeedback which aims to upregulate alpha frequency activity
over sensorimotor areas of the brain can produce substantial improvements in pain. Recent
systematic reviews have called for more robustly designed trials in terms of methodology and
feasibility and for changes in EEG activity to be measured and correlated with outcome
measure assessments.
A recent proof of concept study (Number of participants=16) was conducted in the UK during
the Covid pandemic lockdown in 2020/21, to examine the safety and efficacy of a home-based
EEG neurofeedback intervention for the management of chronic pain and associated symptoms.
This study as referred to below, showed significant improvements in pain, central
sensitisation, sleep, mood and quality of life measures for many of the heterogenous group,
alongside correlations with changes in EEG activity.
Study title: Brain Train for Pain - A home-based neurofeedback intervention to treat the
primary and secondary symptoms of chronic pain.
REC reference: 20/NW/0209 Protocol number: ED1001033 IRAS project ID: 277936
This trial will utilise an updated version of the equipment (Headset, tablet and software
App) and replicate the neurofeedback intervention while expanding on the above study by
showing changes in EEG activity during and after the intervention period in a homogenous
cohort of participants living with chronic neuropathic pain. Furthermore, it will validate
the efficacy of a home-based telehealth intervention for chronic neuropathic pain within the
NHS.
The primary hypotheses of this study are that:
i) 8 weeks of usual care plus active EEG neurofeedback is feasible, safe, and clinically
efficacious, resulting in a reduction in perceived pain, and improvement in central
sensitisation, mood, sleep, and quality of life measures ii) Baseline EEG resting state
activity will differ over three time points - pre, during, and post-intervention.
iii) Changes in EEG activity will be correlated with changes in primary and secondary outcome
measures
The research team will conduct a simple single arm cohort study measuring outcomes before and
after an 8-week period of neurofeedback intervention and then throughout a follow up period
of 12 weeks. The total time period for each participant will be 23 weeks.
All potential applicants will be screening against eligibility criteria. Individuals who meet
the eligibility criteria will be invited to take part in this trial.
Potential participants will be recruited from a variety of sources including East Kent
Hospitals University NHS Foundation Trust (EKHUFT) Out-patient clinics (primarily from the
Out-patient clinic of the Chief Investigator), patient association networks (for example:
Kent Multiple Sclerosis Therapy Centre and Headway Kent), NHS primary care in East Kent and
social media may also be used.
Participant time-line -
Week 1 - EEG baseline measurements (5 times during the week for 5 mins) and initial outcome
measurements Week 2 - Transition week - Research team video based appointment for checking
all aspects and further training required and outcome measure assessment.
Weeks 3 to 10 - active self administered neurofeedback treatment by participant at home - 5
times per week for 40 minute sessions.
Weeks 11 to 23 - EEG baseline measurements (5 times per week for 5 mins). 4 video based
follow up appointments with a member of the research team for outcome measurements and
checking and confirmation of any potentially reported issues.
After completion of the trial, all participants will be provided with a debrief document to
enable participants to have an opportunity to discuss anything they would like with the Chief
Investigator and also to enable them to have the opportunity of obtaining a brief 1-page
summary report of the results of the research after all data and results have been analysed.
Statistical Analysis.
Study results will first undergo descriptive level statistical analyses. Continuous variables
will be reported using mean (standard deviation) or median (interquartile range), depending
on the data distribution, and dichotomous and categorical variables will be reported using
frequencies (proportion). All data will be analysed following intention-to-treat principles.
Secondary per protocol analyses may also be completed. The difference in primary and
secondary outcomes will be analysed with linear or general linear mixed effects models,
controlling for baseline scores. The research team will report the number of participants
with missing scores for each outcome and any imputations will be carried out consistent with
the approaches laid out in Gelman and Hill (Ref: Gelman A. and J. Hill, Missing-data
Imputation in Data Analysis Using Regression and Multilevel/Hierarchical models. 2006,
London, UK. p. 529-544.)
The research team will report imputation methods, and will perform a sensitivity analysis,
examining effects on the outcomes reported, using the approach recommended by White et al
(Ref: White, I.R., et al., Strategy for intention to treat analysis in randomised trials with
missing outcome data. BMJ, 2011. 342: p. d40.)
For the secondary outcome measures, linear mixed effects models will also be used to assess
the relationship between % improvement in Brief Pain Inventory and Visual Analogue Scale for
pain average changes 1) in resting EEG alpha frequency band power, relative alpha, hi-beta
and theta, pre to post intervention and at all follow up points. Potentially important
covariates (e.g. baseline pain intensity, psychological distress, sleep quality) will also be
assessed for interaction, collinearity and confounding. With respect to participant safety,
discontinuation rates, adverse events and treatment emergent adverse events will all be
reported and documented.
