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Brain-Computer Interface (BCI)-Based Feedback for Chronic Pain Management

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03032497
Recruitment Status : Completed
First Posted : January 26, 2017
Last Update Posted : September 13, 2019
Sponsor:
Collaborator:
Institute for Infocomm Research
Information provided by (Responsible Party):
Tan Tock Seng Hospital

Brief Summary:

The feasibility study proposed here will primarily examine the sensitivity of an electroencephalogram (EEG)-based Brain Computer Interface (BCI) in detecting significant differences in brain signals in patients with chronic low back pain (N=10), lower limb pain (N=10) and healthy controls (N=10) through perceived movements via a video and during actual movements. The BCI device has been approved for use in previous trials (e.g. NNI-IRB/07/001, DSRB Domain D/09/608, DSRB Domain D/10/072) and the safety and effectiveness of this non-invasive EEG-based BCI device validated through these trials. However, the validation has not been specific to its use in pain. Related to the primary objective of the study, we will develop and validate an adaptive and participant-specific pain detection and analysis program by exploring and identifying discriminative and robust patterns in spontaneous EEG from our study sample.

For the secondary objective, we will develop and validate a BCI and computer based pain and attention diversion training system with interactive audio-visual feedbacks for Phase 2 of the study. These feedbacks will inform the user about the current brain activation level and attention level, and guide the user in learning to modulate the EEG characteristics and develop skills to manage attention to alleviate perceived fear-related pains. The BCI system captures EEG signals and decodes the underlying brain states in relation to cognition and fear-related pain perception. Such decoded brain states are then presented to the participant in visual or other form to guide the participant to learn to regulate the brain states towards better pain management. For example, the participant may over a few sessions learn to focus on the visual feedback while inhibiting the brain function activity in relation to fear-related pain perception. With practice, the user is encouraged to achieve brain activity modulation without external feedback so fear-related pain can be reduced in realistic situations.


Condition or disease Intervention/treatment Phase
Pain, Chronic Device: EEG-based BCI analysis of fear avoidance Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Feasibility of a Brain-Computer Interface (BCI)-Based Adaptive Sensing and Feedback for Chronic Pain Management
Actual Study Start Date : June 5, 2017
Actual Primary Completion Date : March 31, 2019
Actual Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: EEG-based BCI analysis of fear avoidance
All participants complete two experiments one after another-EEG patterns, skin conductance and pulse rate are recorded. The EEG cap is mounted on the participant's head, the GSR sensor secured on the fingers and the PPG sensor secured on the wrist using a Velcro strap. Exp 1-participants watch a series of 15, 1 min videos of people doing daily activities. Exp 2-participants do 15 movements (15 reps each in 1 min) as guided by a physiotherapist. 2 identical buzzers (labelled "lesser pain" and "more pain") are available to press accordingly should participants experience 'lesser' or 'more' pain any time during the experiment. If 'more' pain experienced, participants' condition will be assessed and they can choose to continue the experiment at a lower intensity or stop.
Device: EEG-based BCI analysis of fear avoidance
Scalp EEG signals that are acquired and recorded from experiment 1 and 2 are analysed for healthy controls, participants with low back pain and participants with lower limb pain. Comparisons of signal patterns are made between groups. Assuming unique signal patterns are obtained for each groups, these signals are further analysed and used to develop a feedback brain training system to better manage pain and ideally reduce fear-avoidant behaviors towards pain.




Primary Outcome Measures :
  1. Assessing change in Numerical pain rating scale [ Time Frame: Phase 1: week 1; Phase 2: Week 1, Week 6 and Week 7; Phase 3: Week 1 and week 9 ]
    Measure of pain intensity

  2. Assessing change in Tampa Kinesiophobia Scale (Miller et al., 1991) [ Time Frame: Phase 1: week 1; Phase 2: Week 1, Week 6 and Week 7; Phase 3: Week 1 and week 9 ]
    Measure of fear-avoidance


Secondary Outcome Measures :
  1. Assessing change in Photograph series of daily activities (PHODA-SeV) scale (Leeuw et al., 2007) [ Time Frame: Phase 1: week 1; Phase 2: Week 1, Week 6 and Week 7; Phase 3: Week 1 and week 9 ]
    Measure of patients' perceptions about the consequences of harmful situations based on a series of photographs

  2. Assessing change in Pain Interference Scale on the Brief Pain Inventory (BPI) (Cleeland & Ryan, 1994) [ Time Frame: Phase 1: week 1; Phase 2: Week 1, Week 6 and Week 7; Phase 3: Week 1 and week 9 ]
    Measure of pain interference on daily activities

  3. Assessing change in Short-form 36 questionnaire (SF-36) (Ware & Sherbourne, 1992) [ Time Frame: Phase 1: week 1; Phase 2: Week 1, Week 6 and Week 7; Phase 3: Week 1 and week 9 ]
    Measure of quality of life

  4. Assessing change in Patient Health Questionnaire-9 (PHQ-9) (Spitzer et al., 1999) [ Time Frame: Phase 1: week 1; Phase 2: Week 1, Week 6 and Week 7; Phase 3: Week 1 and week 9 ]
    Measure of Depressive Symptoms

  5. Assessing change in Pain Catastrophizing Scale (PCS) (Sullivan et al., 1995) [ Time Frame: Phase 1: week 1; Phase 2: Week 1, Week 6 and Week 7; Phase 3: Week 1 and week 9 ]
    Measure of pain related catastrophizing

  6. Assessing change in 6 minute Shuttle Walk Test [ Time Frame: Phase 1: week 1; Phase 2: Week 1, Week 6 and Week 7; Phase 3: Week 1 and week 9 ]
    Objective measure of disability



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Only English speaking participants are recruited.

  • Participants who are healthy controls need to meet the following inclusion criteria:

    1. Not suffering from any active pain condition
    2. Without any known disease
    3. Not on any long- term medication or health supplements AND
    4. Able to complete a digital self-report questionnaire in English without need for translation.

Participants who have either low back pain or lower limb pain need to meet the following inclusion criteria:

  1. Diagnosed to have musculoskeletal low back pain OR lower limb pain lasting for > 3 months.
  2. Not currently on any active therapy (Example: physiotherapy, stabilisation exercise therapy) or medication EXCEPT simple analgesics (Paracetamol, Paracetamol/Orphenadrine, Non-steriodal anti-inflammatory drugs (NSAIDs), Tramadol).
  3. Able to complete a digital self-report questionnaire without need for translation.

Exclusion Criteria:

  • Participants are excluded from the study if they meet any of the following criteria:

    1. Pregnant or lactating.
    2. History of drug or alcohol abuse
    3. History of significant moderate to severe systemic disease including a confirmed diagnosis or current investigation for neoplasm, immunological condition involving musculo-skeletal system; active liver, heart and or renal failure; respiratory diseases needing supplementary oxygen or Bilevel Positive Airway Pressure (BiPAP) machine and any other conditions that make it improbable to engage in physical movements.
    4. History of psychiatric condition- in particular a psychiatric diagnosis meeting Diagnostic and Statistical Manual of Mental Disorders-V (DSM-V) criteria for major depression, anxiety, phobias or any other conditions that make it improbable to engage in physical movements.
    5. History of back surgery and surgery involving the joints and bones of the lower limbs, such as knee and hip replacement surgery.
    6. Spine or lower limb pain that has not been medically stabilised.
    7. History of previous injuries to the head and/or brain, including but not limited to epilepsy, skull defects or cranioplasty
    8. Ongoing compensation claims or litigation.

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): NCT03032497


Locations
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Singapore
Tan Tock Seng Hospital, Pain Management Clinic
Singapore, Singapore, 308433
Sponsors and Collaborators
Tan Tock Seng Hospital
Institute for Infocomm Research
Investigators
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Principal Investigator: Su-Yin Yang, PhD Tan Tock Seng Hospital
Publications:
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Responsible Party: Tan Tock Seng Hospital
ClinicalTrials.gov Identifier: NCT03032497    
Other Study ID Numbers: 2016/00516
RRG1/16013 ( Other Grant/Funding Number: Rehabilitation Research Institute of Singapore (RRIS) )
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make IPD available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tan Tock Seng Hospital:
Brain Computer Interface
Electroencephalogram (EEG)
Chronic Pain
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations