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Smartphone-based Brainwave Entrainment (BWE) Technology in Chronic Pain

NCT04493775 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-07-06

No results posted yet for this study

Summary

Is brainwave entrainment a feasible tool for managing long-term pain in a patient population in the home-setting? Long-term pain affects 4 in 10 people in the UK and can impact on all aspects of life. Many people find that their pain is not well controlled on the treatments that are currently available, or they experience unpleasant side-effects from painkillers. There is therefore an urgent need for new safe and effective treatments for long-term pain.

One new approach to treatment is to target alpha brainwaves - rhythmic brain activity that is known to be associated with reduced pain. Alpha brainwaves can be increased by looking at flashing lights or listening to rhythmic sounds at the same rhythm as the brainwaves. This is known as "brainwave entrainment" (BWE) and can be delivered through a smartphone application.

The aim of this study is to test the suitability, acceptability and benefits of the brainwave entrainment smartphone application for people with long-term pain, and to inform the design of a future larger study.

The investigators aim to recruit 40 participants. Individuals may be eligible if they are over 18 years old and have suffered persistent pain for longer than 3 months. Participants will attend a 3-hour session in the laboratory in either Manchester or Leeds. They will undergo brainwave entrainment for different lengths of time whilst their brain activity and pain levels are recorded to determine the most effective "dose" of entrainment for that individual. They will then use the smartphone application at home 3 times a day for 4 weeks, and will complete pain, sleep, fatigue and quality of life questionnaires. At the end of the study, the investigators will conduct interviews to gain in-depth feedback. The total duration for each participant is around 7 weeks. This study is funded by a Leeds Cares Clinical Research Fellowship.

Conditions

Interventions

DEVICE

Brainwave Entrainment

Alpha frequency visual and auditory stimulation delivered through a smartphone application, with the use of a virtual reality headset and earphones respectively.

Sponsors & Collaborators

  • University of Leeds

    collaborator OTHER

  • Helen Locke

    lead OTHER

Principal Investigators

  • Jones · University of Manchester

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2023-10-01
Completion
2024-10-01

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT04493775 on ClinicalTrials.gov