NCT04097522

Brief Summary

This study evaluates the effectiveness of neurofeedback (teaching participants to gain control over their own brainwaves) in chronic pain. The study is made up of four pilot studies. Participants who take part will undergo the cold pressor test, submerging their hand in cold water in order to simulate chronic pain. Brain activity will be measured using electroencephalography (EEG).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P50-P75 for not_applicable chronic-pain

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2018

Completed
12 days until next milestone

Study Start

First participant enrolled

December 3, 2018

Completed
10 months until next milestone

First Posted

Study publicly available on registry

September 20, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2020

Completed
Last Updated

April 16, 2020

Status Verified

April 1, 2020

Enrollment Period

1.8 years

First QC Date

November 21, 2018

Last Update Submit

April 15, 2020

Conditions

Chronic Pain

Keywords

neurofeedback

Outcome Measures

Primary Outcomes (1)

  • Changes in pain ratings

    The investigators will monitor changes in pain ratings, which are ratings of current pain level, given on a scale from 0-10 using a Visual Analogue Scale (VAS). These ratings will be given by participants while undergoing the experimental procedures in the study.

    Throughout the participant's time in the study, approximately 8-16 weeks. (16 sessions which occur approximately twice per week,depending on participant's availability.).

Secondary Outcomes (14)

  • Smartphone app measures of changes in of chronic pain-related symptoms

    Throughout the participant's time in the study, an average of 12 weeks.

  • Changes in brain activity caused by neurofeedback procedures

    Throughout the participant's time in the study, an average of 12 weeks.

  • Self-report: participant's own ratings of pain experienced

    through study completion, an average of 12 weeks.

  • Questionnaire: Brief Pain Inventory

    through study completion, an average of 12 weeks.

  • Questionnaire: Participant Demographics

    Administered at initial session, one day only

  • +9 more secondary outcomes

Study Arms (2)

real neurofeedback

ACTIVE COMPARATOR

Participants receive neurofeedback from a region of the brain thought to be associated with increasing pain resilience

Other: Neurofeedback

sham neurofeedback

SHAM COMPARATOR

Participants receive neurofeedback from a region of the brain thought to be unrelated with increasing pain resilience

Other: Neurofeedback

Interventions

NeurofeedbackOTHER

During the neurofeedback intervention, participants will be shown visual representations of their own brain activity in real-time. Over a number of sessions participants will teach themselves to increase this brain activity, in order to increase their own pain resilience levels.

real neurofeedbacksham neurofeedback

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Willing and able to give informed consent for participation in the study
  • Must be aged 40 or older

You may not qualify if:

  • Current or planned hospitalisation during the period of study.
  • Non-English speaking participants
  • Participants already involved in clinical trials, if it is not possible to schedule around this
  • Unable, in the opinion of the research investigator, to comply or adhere to the requirements of the study.
  • Patients with chronic pain in both upper limbs
  • History of brain injury, stroke or neurosurgical procedures
  • An implanted neurostimulator (e.g., deep brain stimulator)
  • Damaged skin tissue on the head, or a skin condition such as severe eczema, or any skin allergies
  • Failure of cognitive test (Montreal Cognitive Assessment) will exclude participants from taking part in studies that use neurofeedback procedures
  • Some but not all of the study will be unavailable to participants currently undergoing psychotherapy (such as cognitive behavioural therapy).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Salford Royal NHS Foundation Trust

Salford, Greater Manchester, M6 8HD, United Kingdom

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Interventions

Neurofeedback

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biofeedback, PsychologyMind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, Psychological

Central Study Contacts

James Henshaw, PhD

CONTACT

0161 206 4528james.henshaw-2@manchester.ac.uk

Tim Rainey

CONTACT

01612060205timothy.rainey@manchester.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
A number of the studies include double-blind neurofeedback, where half of the participants receive sham neurofeedback, and half receive actual neurofeedback from a region thought to increase pain resilience. The experimenter, participant, and care provider will all be blinded as to which condition the participant is in until the participant leaves the study.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Half of the participants that take part in the neurofeedback procedures will receive sham neurofeedback, whilst the other half will receive neurofeedback from an area the investigators believe to be associated with increasing pain resilience. Participants may or may not receive sham neurofeedback, and will be made aware of this fact.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

November 21, 2018

First Posted

September 20, 2019

Study Start

December 3, 2018

Primary Completion

October 5, 2020

Study Completion

October 5, 2020

Last Updated

April 16, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will share

No individually identifiable participant data will be shared outside of the research group, and the University of Manchester (for the purposes of audit). Non-identifiable (pseudo-anonymised) data will be shared with TIYGA Health through their phone app if participants choose to upload this information, however, no phone location data, names, ore any other personal information will be shared with them. Participants are free to choose not to use the phone app with no penalties for not taking part

Time Frame
Non-identifiable information will be shared, only when participants choose to share it during the neurofeedback training sessions (8-16 weeks). TIYGA Health will retain the data in line with GDPR (General Data Protection Regulation) requirements for pseudo-anonymised data - retaining data for 5 years before deletion (after last data entry), and may archive accounts if no new data is added for 2 years
Access Criteria
Please contact us at james.henshaw-2@manchester.ac.uk and we will provide email access to the full DMP (Data Management Plan, available at link below)
More information

Locations

GB(1)