Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effectiveness of Neurofeedback for the Treatment of Chronic Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04097522
Recruitment Status : Recruiting
First Posted : September 20, 2019
Last Update Posted : September 25, 2019
Sponsor:
Collaborator:
TIYGA Health
Information provided by (Responsible Party):
Anthony Jones, University of Manchester

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).

Condition or disease Intervention/treatment Phase
Chronic Pain Other: Neurofeedback Not Applicable

Detailed Description:

Chronic pain is a persisting pain which often exists in the absence of detectable tissue damage. It is also associated with feelings of depression, anxiety, and despair. Current treatments for chronic pain usually involves drug treatments, which often has unwanted side effects.

This study aims to assess the effectiveness of neurofeedback, which refers to teaching participants to gain control over their own brainwaves, as an intervention to treat chronic pain. It is believed that by teaching participants to gain control over a brain signal associated with pain resilience, the participant can reduce some of the negative effects associated with chronic pain.

Participants who take part in this study will have their brain activity recorded using electroencephalography (EEG), and have pain elicited using the cold pressor test (CPT), which involves the participant submerging their wrist in cold water to elicit a chronic pain-like sensation. This is a safe, regularly used method, and the participant is free to remove their hand early if the pain becomes too great.

Some participants who take part will undergo neurofeedback training, which will involve them viewing a signal associated with pain resilience, and learning to increase it over multiple sessions.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Neurofeeback for Chronic Pain Project (NFB Project)
Actual Study Start Date : December 3, 2018
Estimated Primary Completion Date : January 14, 2020
Estimated Study Completion Date : January 14, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Active Comparator: real neurofeedback
Participants receive neurofeedback from a region of the brain thought to be associated with increasing pain resilience
Other: Neurofeedback
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.

Sham Comparator: sham neurofeedback
Participants receive neurofeedback from a region of the brain thought to be unrelated with increasing pain resilience
Other: Neurofeedback
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.




Primary Outcome Measures :
  1. Changes in pain ratings [ Time Frame: 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.). ]
    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.


Secondary Outcome Measures :
  1. Smartphone app measures of changes in of chronic pain-related symptoms [ Time Frame: Throughout the participant's time in the study, an average of 12 weeks. ]
    Participants may be given a smartphone app with which to record their current chronic pain levels using sliders. The sliders have no units, sliding towards maximum will indicate high chronic pain, sliding towards minimum indicates low chronic pain. Participants will be free to choose whether to use this or not.

  2. Changes in brain activity caused by neurofeedback procedures [ Time Frame: Throughout the participant's time in the study, an average of 12 weeks. ]
    The investigators will monitor changes in brain activity associated with neurofeedback procedures, measured using EEG (focusing on the alpha band). It is expected that neurofeedback will cause an increase in brain activity associated with pain resilience.

  3. Self-report: participant's own ratings of pain experienced [ Time Frame: through study completion, an average of 12 weeks. ]
    Participant will self-report on their own levels of pain experienced, using a visual analogue scale (VAS) from 0 (no pain) to 10 (worst pain imaginable).

  4. Questionnaire: Brief Pain Inventory [ Time Frame: through study completion, an average of 12 weeks. ]
    Participant self-assesses current or recent pain using a scale which ranges from from 0 (no pain/does not interfere) to 10 (worst pain imaginable/completely interferes), with high scores representing a worse outcome.

  5. Questionnaire: Participant Demographics [ Time Frame: Administered at initial session, one day only ]
    General information about participant's age, gender, etc

  6. Questionnaire: EQ5D (developed by EuroQol group) [ Time Frame: through study completion, an average of 12 weeks. ]
    General measure of overall health, includes a scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state), with 0 representing the worst outcome

  7. Questionnaire: Hospital Anxiety and Depression Scale [ Time Frame: through study completion, an average of 12 weeks. ]
    Participant self-reports feelings of anxiety and depression, ticking against responses representing their current feelings.

  8. Questionnaire: McGill Short Form [ Time Frame: through study completion, an average of 12 weeks. ]
    Questionnaire assessing participants current pain level

  9. Questionnaire: Medical history [ Time Frame: Administered at initial session, one day only ]
    Participant notes current medications and previous major operations

  10. Assessment: Montreal Cognitive Assessment [ Time Frame: through study completion, an average of 12 weeks. ]
    Used to assess participant's cognitive abilities, several questions are answered verbally or by writing on the form

  11. Questionnaire: Pain Catastrophizing Scale [ Time Frame: through study completion, an average of 12 weeks. ]
    Measures the extent to which a person 'catastrophises' i.e. overly worries about a pain or events associated with pain, and includes a scale ranging from 0 (Not at all) to 4 (all the time), with high scores for negatively phrased events representing the worst outcomes

  12. Questionnaire: PANAS (Positive and Negative Affect Schedule) [ Time Frame: through study completion, an average of 12 weeks. ]
    Participant rates a number of words which describe different feelings and emotions, and includes a scale ranging from 1 (Very slightly or not at all) to 5 (Extremely), with high scores for negatively phrased events representing the worst outcomes

  13. Questionnaire: PSEQ (Pain Self-Efficacy Questionnaire) [ Time Frame: through study completion, an average of 12 weeks. ]
    Participant rates how confident they are that they can do the following things at present, despite their current pain. Scale ranges from 0 (not confident at all) to 6 (completely confident), with a high score indicating confidence in one's own ability to cope or perform a task despite the pain

  14. Assessment: Tender Points Survey [ Time Frame: through study completion, an average of 12 weeks. ]
    Assessor gently but firmly presses a finger against certain pressure points on the participant to asses levels of pain.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04097522


Contacts
Layout table for location contacts
Contact: James Henshaw, PhD 0161 206 4528 james.henshaw-2@manchester.ac.uk
Contact: Tim Rainey 01612060205 timothy.rainey@manchester.ac.uk

Locations
Layout table for location information
United Kingdom
Salford Royal NHS Foundation Trust Recruiting
Salford, Greater Manchester, United Kingdom, M6 8HD
Contact: James Henshaw, PhD    0161 206 4528    james.henshaw-2@manchester.ac.uk   
Contact: Tim Rainey    0161 206 0205    timothy.rainey@manchester.ac.uk   
Sponsors and Collaborators
University of Manchester
TIYGA Health

Layout table for additonal information
Responsible Party: Anthony Jones, Clinical Professor, University of Manchester
ClinicalTrials.gov Identifier: NCT04097522     History of Changes
Other Study ID Numbers: 244779
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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)
URL: https://dmponline.dcc.ac.uk/plans/29612

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anthony Jones, University of Manchester:
neurofeedback
Additional relevant MeSH terms:
Layout table for MeSH terms
Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms