Brain-Computer Interface (BCI)-Based Feedback for Chronic Pain Management
CompletedNot applicableNCT03032497
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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…
Study details
- Official title
- Feasibility of a Brain-Computer Interface (BCI)-Based Adaptive Sensing and Feedback for Chronic Pain Management
- Conditions
- Interventions
- Device: EEG-based BCI analysis of fear avoidance
- Sponsor
- Tan Tock Seng Hospital
- Collaborators
- Institute for Infocomm Research
- Start date
- 2017-06-05
- Primary completion
- 2019-03-31
- Sex
- All
- Age range
- from 21 Years to 65 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- Singapore
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03032497