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Home-based EEG Neurofeedback for Chronic Neuropathic Pain

NCT05464199 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2023-09-13

No results posted yet for this study

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.

Conditions

  • Neuralgia

Interventions

OTHER

Neurofeedback training

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.

Sponsors & Collaborators

  • Exsurgo Ltd

    collaborator UNKNOWN

  • East Kent Hospitals University NHS Foundation Trust

    lead OTHER_GOV

Principal Investigators

  • Dr Mohamed Sakel, MBBS · East Kent Hospitals University NHS Foundation Trust

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-06
Primary Completion
2023-07-01
Completion
2023-08-16

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05464199 on ClinicalTrials.gov