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

NCT04493775 | Unknown

• 1 other identifier: NHS001675
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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

Chronic Pain

Keywords

Alpha rhythm; EEG phase synchronisation; Mobile applications; Pain perception; Pain management

Outcome Measures

Primary Outcomes (2)

• Numerical pain ratings (NRS)

  0-10 where 0 = no pain and 10 = worst pain. To indicate whether there is a dose-related change in efficacy of BWE.

  2 years

• Qualitative data from semi-structured interviews

  This will answer key feasibility questions to enable planning of a future clinical trial. This will include information on acceptability and usability of the intervention, feedback on the outcome measures used, engagement with the research, process issues including recruitment, and the extent to which they felt the intervention improved their pain.

  2 years

Secondary Outcomes (5)

• Electroencephalography data

  1 year

• Pittsburgh sleep quality index (PSQI)

  2 years

• Multidimensional Fatigue Inventory (MFI)

  2 years

• EuroQol - 5 dimensions (EQ-5D)

  2 years

• Brief Pain Inventory (BPI)

  2 years

Interventions

Brainwave Entrainment DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults over the age of 18 years (there is no upper age limit as we would want the intervention to be as inclusive as possible)
• clinically significant non-cancer-related chronic pain (for which they have sought medical input) for more than three months' duration
• willing and able to consent to taking part.

You may not qualify if:

• any history or first-degree relative history of epilepsy or convulsions/seizures
• discomfort with flashing lights
• history of recurrent headaches or migraines
• participants who have difficulty understanding verbal or written English, or who have cognitive or mental health problems that would prevent them being able to provide written informed consent
• planned intervention (surgery, new medications or treatments) during the study period.

Sponsors & Collaborators

• Helen Locke: lead
• University of Leeds: collaborator

Study Sites (2)

University of Manchester

Manchester, Lancashire, M13 9PL, United Kingdom

Location

University of Leeds

Leeds, West Yorkshire, LS1 3EX, United Kingdom

Location

MeSH Terms

Conditions

Chronic Pain; Agnosia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Jones

  University of Manchester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Locke

CONTACT

01612064266; Helen.locke@manchester.ac.uk

Sivan

CONTACT

01612064266; Manoj.sivan@manchester.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Neither the researcher delivering the intervention nor the participant will know the selected sequence at the start, however, it will not be possible for either the researcher or the participant to be completely blinded to the sequence once it is underway, given that the differences in duration of stimulation are likely to be quite apparent.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Research Fellow

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: July 30, 2020
• Study Start: October 1, 2021
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2024
• Last Updated: July 6, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)