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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
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
|Tan Tock Seng Hospital, Pain Management Clinic|
|Singapore, Singapore, 308433|
|Principal Investigator:||Su-Yin Yang, PhD||Tan Tock Seng Hospital|