NCT04418362

Brief Summary

A mixed methods proof of concept study to ascertain the effectiveness of a home-based self-administered neurofeedback intervention to treat the primary and secondary symptoms of chronic pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable chronic-pain

Timeline
Completed

Started Jun 2020

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

May 29, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 5, 2020

Completed
11 days until next milestone

Study Start

First participant enrolled

June 16, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2021

Completed
Last Updated

March 23, 2022

Status Verified

July 1, 2020

Enrollment Period

8 months

First QC Date

May 29, 2020

Last Update Submit

March 21, 2022

Conditions

Chronic PainDepression, AnxietySleepQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Change in pain intensity as measured by the VNS (Visual Numerical Scale)

    Ordinal measurement of individual's pain intensity

    Pre-intervention, before and after each training session over 8 week period, and 1, 3 and 6 months after final training session

Secondary Outcomes (5)

  • Change in mood as measured by Hospital Anxiety and Depression Scale (HADS)

    Pre-intervention, after the final training session (8 weeks), and 1, 3 and 6 months after final session

  • Change in quality of sleep as measured by the Pittsburgh Sleep Quality Index (PSQI)

    Pre-intervention, after the final training session (8 weeks), and 1, 3 and 6 months after final session

  • Change in quality of life components as measured by the EQ-5D-5L

    Pre-intervention, after the final training session (8 weeks), and 1, 3 and 6 months after final session

  • Changes in EEG activity

    Baseline (eyes open and eyes closed) pre-intervention, and before and after each training session over 8 weeks

  • Experience of chronic pain and neurofeedback training

    Post-intervention - after final training session (8 weeks)

Study Arms (1)

Neurofeedback training

EXPERIMENTAL

Neurofeedback training: self-administered at home 4-6 times per week for 8 weeks. Each session consists of 6 blocks of 5 minute training with a one minute rest period between each block.

Other: Neurofeedback training

Interventions

Neurofeedback trainingOTHER

A home-based self-administered neurofeedback intervention taking place 4-6 times per week for 8 weeks.

Neurofeedback training

Eligibility Criteria

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

You may qualify if:

  • Head circumference range (560 - 595 mm)
  • Patients suffering from chronic pain (mean VNS \>4) for at least 6 months.
  • Chronic pain from any neurological or musculoskeletal cause, of which examples could be, post herpetic (or post-shingles) neuralgia, complex regional pain syndrome (CRPS), lower back pain, neck pain, major joint pain, spinal cord injury, phantom limb pain, brachial plexus injury related pain, traumatic peripheral nerve injury pain and post-cancer treatment pain
  • Stable medication and treatment over the intervention period
  • Participant or caregiver with minimum computer literacy able to effectively operate equipment after training, and the ability to position and remove headset effectively for training sessions

You may not qualify if:

  • Failing pre-screening suitability criteria for neurofeedback due to a neurological disorder, psychiatric disorder, epilepsy, regular use of benzodiazepines, previous neurofeedback training, serious head injury and other medication that has contraindications for neurofeedback training
  • Dreadlocks, braids, beads, or any other hairstyle or hair covering that cannot be removed for training
  • Known or suspected pregnancy
  • Diagnosis of (or currently undergoing treatment for) cancer, systemic infection, severe cardiovascular/respiratory comorbidity
  • Implanted electronic neuromodulation device
  • Implanted pacemaker or loop recorder
  • Any change in medication or treatment planned during the intervention period
  • Inability to use the equipment due to severity of pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

East Midlands Spine Ltd

Northampton, United Kingdom

Location

Related Publications (1)

  • Birch N, Graham J, Ozolins C, Kumarasinghe K, Almesfer F. Home-Based EEG Neurofeedback Intervention for the Management of Chronic Pain. Front Pain Res (Lausanne). 2022 May 27;3:855493. doi: 10.3389/fpain.2022.855493. eCollection 2022.

    PMID: 35712448DERIVED

MeSH Terms

Conditions

Chronic PainDepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorMental Disorders

Study Officials

  • Nicholas Birch

    East Midlands Spine Ltd

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single group assignment
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2020

First Posted

June 5, 2020

Study Start

June 16, 2020

Primary Completion

January 31, 2021

Study Completion

July 28, 2021

Last Updated

March 23, 2022

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)