NCT05464199

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 19, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

October 6, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2023

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

9 months

First QC Date

June 27, 2022

Last Update Submit

September 11, 2023

Conditions

Neuralgia

Keywords

Neurofeedback

Outcome Measures

Primary Outcomes (2)

  • Visual Analogue Pain Scale

    Unidimensional measure of pain intensity - Numeric scale from 0 (no pain) to 10 (worst pain ever). Number is chosen by participant to rate their pain.

    23 weeks

  • Brief Pain Inventory

    A self-reported scale that measures the frequency, and severity of pain and the interference of pain on various domains of daily activity. The severity items ratings range from 0 (no pain) to 10 (pain as bad as you can imagine).

    23 weeks

Secondary Outcomes (6)

  • Depression Anxiety and Stress Outcome Scale 21

    23 weeks

  • Pain Catastrophizing Scale

    23 weeks

  • Central Sensitization Inventory

    23 weeks

  • Pittsburg Sleep Quality Index

    23 weeks

  • Health related perceived quality of life EuroQol scale

    23 weeks

  • +1 more secondary outcomes

Study Arms (1)

Participants receiving neurofeedback intervention

EXPERIMENTAL

Self administered neurofeedback training - Use of Headset and tablet with software App for playing a selected neurofeedback game. The EEG headset and tablet-based application is designed with the purpose of alleviating chronic pain by providing the user with feedback of, and allowing them to modulate, their own EEG signals associated with activity in brain networks related to pain perception and pain modulation.

Other: Neurofeedback training

Interventions

Neurofeedback trainingOTHER

Self-administered neurofeedback treatment using headset and tablet-based application, designed with the purpose of alleviating chronic pain by providing the user with feedback of, and allowing them to modulate, their own brain EEG signals associated with activity in brain networks related to pain perception and pain modulation. Visual feedback will be provided onscreen representing the participant's real time EEG activity measured by the headset. Each session will be split into five blocks of five minutes each, with a one-minute rest period in between, in order to avoid fatigue and allow the participant to move around and adjust their position. After each rest block, participants will be asked if they are ready to proceed and when ready, the next block can be started. After the end of the session (5 blocks) the participant will then be asked to perform a post-session eyes-open EEG recording, similar to the eyes-open baseline taken at the start of the session.

Participants receiving neurofeedback intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females over 18 years of age with ongoing chronic neuropathic pain for 3 months or more
  • must have had an average pain rating in the last week of equal to or greater than 4/10 on Visual Analogue Scale for Pain
  • must have a head circumference between 520-620 mm to ensure correct fitment of headset
  • must have access to a reliable internet connection and Wi-Fi at home
  • must have and display competence with equipment and headset usage after training

You may not qualify if:

  • Previous neurofeedback training
  • serious recent (within 12 months) head injury and/or traumatic brain injury and/or concussion
  • diagnosed with a major neurological disorder (e.g. trigeminal neuralgia)
  • a history of seizures
  • diagnosed with a major psychiatric disorder
  • has an implanted electronic neuromodulation device for example - a heart pacemaker, or loop recorder
  • is unable to provide informed consent
  • must not have any change in medication or treatment planned in the 1 week prior to and during the trial intervention period, or in the 12 weeks post trial intervention, while EEG baselines are being recorded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

East Kent Hospitals University NHS Trust

Canterbury, Kent, CT1 3NG, United Kingdom

Location

Related Publications (1)

  • Sakel M, Ozolins CA, Saunders K, Biswas R. A home-based EEG neurofeedback treatment for chronic neuropathic pain-a pilot study. Front Pain Res (Lausanne). 2025 Mar 11;6:1479914. doi: 10.3389/fpain.2025.1479914. eCollection 2025.

    PMID: 40134759DERIVED

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Dr Mohamed Sakel, MBBS

    East Kent Hospitals University NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single cohort
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2022

First Posted

July 19, 2022

Study Start

October 6, 2022

Primary Completion

July 1, 2023

Study Completion

August 16, 2023

Last Updated

September 13, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)