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

NCT03032497 | Completed DMC

• 2 other identifiers: 2016/00516RRG1/16013
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Chronic

Keywords

Brain Computer Interface; Electroencephalogram (EEG); Chronic Pain

Outcome Measures

Primary Outcomes (2)

• Assessing change in Numerical pain rating scale

  Measure of pain intensity

  Phase 1: week 1; Phase 2: Week 1, Week 6 and Week 7; Phase 3: Week 1 and week 9

• Assessing change in Tampa Kinesiophobia Scale (Miller et al., 1991)

  Measure of fear-avoidance

  Phase 1: week 1; Phase 2: Week 1, Week 6 and Week 7; Phase 3: Week 1 and week 9

Secondary Outcomes (6)

• Assessing change in Photograph series of daily activities (PHODA-SeV) scale (Leeuw et al., 2007)

  Phase 1: week 1; Phase 2: Week 1, Week 6 and Week 7; Phase 3: Week 1 and week 9

• Assessing change in Pain Interference Scale on the Brief Pain Inventory (BPI) (Cleeland & Ryan, 1994)

  Phase 1: week 1; Phase 2: Week 1, Week 6 and Week 7; Phase 3: Week 1 and week 9

• Assessing change in Short-form 36 questionnaire (SF-36) (Ware & Sherbourne, 1992)

  Phase 1: week 1; Phase 2: Week 1, Week 6 and Week 7; Phase 3: Week 1 and week 9

• Assessing change in Patient Health Questionnaire-9 (PHQ-9) (Spitzer et al., 1999)

  Phase 1: week 1; Phase 2: Week 1, Week 6 and Week 7; Phase 3: Week 1 and week 9

• Assessing change in Pain Catastrophizing Scale (PCS) (Sullivan et al., 1995)

  Phase 1: week 1; Phase 2: Week 1, Week 6 and Week 7; Phase 3: Week 1 and week 9

Study Arms (1)

EEG-based BCI analysis of fear avoidance

EXPERIMENTAL

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

Interventions

EEG-based BCI analysis of fear avoidance DEVICE

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.

EEG-based BCI analysis of fear avoidance

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Only English speaking participants are recruited.
• Not suffering from any active pain condition
• Without any known disease
• Not on any long- term medication or health supplements AND
• Able to complete a digital self-report questionnaire in English without need for translation.
• Diagnosed to have musculoskeletal low back pain OR lower limb pain lasting for \> 3 months.
• 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).
• Able to complete a digital self-report questionnaire without need for translation.

You may not qualify if:

• Participants are excluded from the study if they meet any of the following criteria:
• Pregnant or lactating.
• History of drug or alcohol abuse
• 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.
• 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.
• History of back surgery and surgery involving the joints and bones of the lower limbs, such as knee and hip replacement surgery.
• Spine or lower limb pain that has not been medically stabilised.
• History of previous injuries to the head and/or brain, including but not limited to epilepsy, skull defects or cranioplasty
• Ongoing compensation claims or litigation.

Sponsors & Collaborators

• Tan Tock Seng Hospital: lead
• Institute for Infocomm Research: collaborator

Study Sites (1)

Tan Tock Seng Hospital, Pain Management Clinic

Singapore, 308433, Singapore

Location

Related Publications (3)

• Jensen MP, Sherlin LH, Fregni F, Gianas A, Howe JD, Hakimian S. Baseline brain activity predicts response to neuromodulatory pain treatment. Pain Med. 2014 Dec;15(12):2055-63. doi: 10.1111/pme.12546. Epub 2014 Oct 7.

  PMID: 25287554 BACKGROUND

• Jensen MP, Hakimian S, Sherlin LH, Fregni F. New insights into neuromodulatory approaches for the treatment of pain. J Pain. 2008 Mar;9(3):193-9. doi: 10.1016/j.jpain.2007.11.003. Epub 2007 Dec 21.

  PMID: 18096437 BACKGROUND

• Pinheiro ES, de Queiros FC, Montoya P, Santos CL, do Nascimento MA, Ito CH, Silva M, Nunes Santos DB, Benevides S, Miranda JG, Sa KN, Baptista AF. Electroencephalographic Patterns in Chronic Pain: A Systematic Review of the Literature. PLoS One. 2016 Feb 25;11(2):e0149085. doi: 10.1371/journal.pone.0149085. eCollection 2016.

  PMID: 26914356 BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Su-Yin Yang, PhD

  Tan Tock Seng Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2017
• First Posted: January 26, 2017
• Study Start: June 5, 2017
• Primary Completion: March 31, 2019
• Study Completion: March 31, 2019
• Last Updated: September 13, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)