Research
Research Overview
SynapSense conducts human-subject research to evaluate whether non-invasive EEG can capture reproducible neural signatures associated with pain states. All research activities are designed to prioritize participant safety, methodological rigor, and ethical compliance, while generating high-quality datasets suitable for biomarker discovery and validation.
The current research phase focuses on feasibility, signal reliability, and construct validity, rather than clinical deployment or diagnostic claims.
Research Objectives
The primary objectives of the SynapSense research program are:
To determine whether pain-related neural activity can be reliably detected using non-invasive EEG
To identify EEG features that systematically change across baseline, pain induction, and recovery phases
To evaluate correlations between neural features and repeated self-reported pain measures
To assess within-subject stability and between-subject variability of candidate biomarkers
To establish a validated methodological foundation for future translational studies
Study Design
Study Type
The current study is a mixed-method, cross-sectional investigation with repeated measures. Each participant completes a single laboratory session lasting approximately 90 to 120 minutes.
Controlled experimental manipulation of pain states
Continuous neural recording
Repeated subjective labeling
Post-task qualitative feedback
Participant Population
Eligibility
Participants include adults aged 18 to 65 from two cohorts:
- Individuals living with chronic pain
- Healthy control participants with no history of chronic pain
All participants must be medically stable, capable of providing informed consent, and fluent in English.
Exclusion Criteria
- History of epilepsy or seizure disorders
- Acute intoxication or recent sedative/opioid use
- Pregnancy
- Active scalp dermatologic conditions
- Incompatible implants or devices
- Psychiatric instability
Ethical Oversight and Consent
All research activities are conducted under Institutional Review Board (IRB) oversight. Participants provide written informed consent prior to any study procedures.
Explanation of study purpose and procedures
Discussion of risks, benefits, and alternatives
Emphasis on voluntary participation and right to withdraw
Opportunity to ask questions and receive clarification
Participants may discontinue participation without penalty at any point during the study.
Experimental Procedure
Session Structure
Participants complete demographic and medical history questionnaires, along with validated pain-related surveys for contextual information and subgroup analysis.
A research-grade EEG cap is fitted according to the international 10-20 system. Electrode impedances are checked and reduced to acceptable thresholds.
Baseline neural activity is recorded during alternating eyes-open and eyes-closed conditions to establish an individualized neural reference state.
Experimental Pain Induction Tasks
To induce controlled, temporary pain states, participants complete three standardized experimental paradigms. These tasks are widely used in pain research and selected for their safety, reproducibility, and controllability.
Participants immerse their non-dominant hand in cold water (1-9°C) for a maximum of 120 seconds. They may withdraw at any time if discomfort becomes intolerable.
A standard sphygmomanometer cuff is applied and inflated above resting systolic pressure. Occlusion is maintained for up to five minutes or until participant requests termination.
Surface electrodes deliver mild electrical stimulation for up to ten minutes. Intensity is gradually increased until predefined pain threshold or participant request.
All tasks are continuously supervised, time-limited, and governed by strict safety criteria.
Pain Labeling and Behavioral Measures
Continuous Pain Ratings
During each pain task, participants provide Visual Analog Scale (VAS) ratings at regular intervals, generating a time-resolved subjective pain profile aligned with EEG recordings.
Multidimensional Assessment
Following each task, participants complete the McGill Pain Questionnaire to capture qualitative and affective dimensions of pain beyond intensity alone.
Cognitive-Affective Context
Participants complete the Pain Catastrophizing Scale to assess baseline cognitive and emotional factors that may influence pain perception and reporting.
Recovery and Modulation Phase
After each pain induction task, participants undergo a structured recovery period involving passive rest and paced breathing. EEG recording continues throughout this phase to capture neural dynamics associated with pain resolution and autonomic regulation.
Recovery-phase data are treated as a distinct analytical condition rather than a return to baseline, allowing investigation of post-pain neural modulation.
Qualitative Feedback and Usability
At the conclusion of the session, participants engage in a brief semi-structured interview addressing:
- Comfort and tolerability of the EEG setup
- Perceived difficulty or distress during tasks
- Overall study experience
This feedback informs future protocol refinement and human factors considerations.
Data Management and Security
All data are de-identified and labeled only with numerical subject identifiers. Identifiable information is stored separately under restricted access.
Encrypted storage
Institution-approved secure systems
Access limited to trained personnel
Research Stage and Limitations
The current research phase is exploratory and feasibility-focused. Findings are intended to inform future validation studies rather than support clinical deployment.
Acknowledged Limitations
- Single-session design
- Controlled laboratory conditions
- Sample size appropriate for feasibility rather than population inference
Commitment to Responsible Research
SynapSense is committed to:
Ethical human-subject research
Transparent methodology
Conservative interpretation of findings
Publication through appropriate academic channels
Scientific credibility and participant safety are prioritized over speed or commercialization.