Can Portable EEGs Make Seizure Diagnosis More Accessible for Children in Columbia?

Introduction

Globally, approximately 80% of individuals with epilepsy live in low- and middle-income countries (LMICs), where significant diagnostic and treatment gaps persist (WHO). Access to neurodiagnostic testing is particularly limited in rural and underserved areas, where distance from hospitals and specialty centers delays diagnosis and appropriate care (Coleman et al., 2002; Mbuba et al., 2012; Buchalter et al., 2022). In the United States, pediatric patients in underserved communities face substantial barriers to accessing electroencephalography (EEG) testing, a critical diagnostic tool for seizure disorders.

Traditional hospital-based EEG requires specialized equipment, trained technologists, and developed infrastructure. Patients often must travel long distances to access these services, creating barriers related to transportation, time off work, and associated costs (Buchalter et al., 2022). These challenges are particularly pronounced in states like Texas, where geographic distances between major medical centers can be substantial.

Mobile EEG platforms, combined with telemedicine approaches, have emerged as promising solutions to improve access, adherence, and clinical outcomes for patients with seizure disorders (Patel et al., 2019; Wechsler et al., 2013). The BrainCapture (BC-1) system represents a new generation of portable, low-cost, HIPAA-compliant EEG devices designed to generate high-quality recordings even when operated by inexperienced users (Armand et al., 2024). The system consists of a lightweight recording device, age-appropriate electrode caps, and a mobile application interface that can be used in various clinical and community settings.

Despite the theoretical advantages of mobile EEG technology, limited research has examined real-world feasibility, acceptability, and clinical performance from the perspectives of multiple stakeholders. Understanding how clinicians, patients, and caregivers perceive and interact with mobile EEG systems is critical for successful implementation, particularly in underserved populations where trust in healthcare technology and comfort with novel diagnostic approaches may vary (Gajarawala & Pelkowski, 2020; Butzner et al., 2021).

This study addresses these knowledge gaps by conducting the first comprehensive evaluation of the BrainCapture (BC-1) system with pediatric patients who have confirmed seizure disorders and their caregivers, as well as practicing pediatric neurologists. By examining perspectives across diverse geographic and socioeconomic contexts in Texas, this research will generate essential evidence to inform broader implementation strategies for portable neurodiagnostic technologies.

Study Objectives and Outcome Measures

Primary

To evaluate the feasibility and acceptability of the BrainCapture (BC-1) mobile EEG platform among pediatric neurologists, patients with seizure disorders, and their caregivers in Texas.

Primary Outcome Measures:

1. Clinician acceptability: Percentage of pediatric neurologists rating overall system acceptability ≥4 on 5-point Likert scale. Timepoint: Immediately post-interview and device demonstration

2. Patient/caregiver acceptability: Percentage of patient-caregiver dyads rating overall system acceptability ≥4 on 5-point Likert scale. Timepoint: Immediately post-EEG recording session

3. Technical feasibility: Percentage of EEG recording sessions yielding ≥10 minutes of interpretable data as assessed by pediatric neurologists. Timepoint: Within 2 weeks of recording session

Secondary

To assess preliminary clinical performance of BC-1 recordings compared to standard hospital-based EEGs and to evaluate caregiver burden and implementation considerations.

Secondary Outcome Measures:

1. Clinical agreement: Inter-rater reliability between BC-1 and hospital EEG interpretations (where available). Timepoint: Within 1 month of recording session

2. Caregiver burden assessment: Thematic analysis of perceived impact on travel time, work absence, and family logistics. Timepoint: During post-recording interview

3. Implementation metrics: Setup time, battery life, data export success rate, and user experience ratings. Timepoint: During each recording session

Tertiary/Exploratory

To identify barriers and facilitators for integrating mobile EEG into clinical workflows and to explore demographic factors associated with acceptability.

Tertiary/Exploratory Outcome Measures:

1. Workflow integration themes: Qualitative analysis of clinician-identified barriers and facilitators. Timepoint: During interviews

2. Demographic correlates: Association between participant characteristics (age, income, education, prior technology use) and acceptability ratings. Timepoint: Post-study analysis

Study Design

This is a mixed-methods observational study combining qualitative interviews with quantitative pilot testing of the BrainCapture (BC-1) mobile EEG system. The study employs a concurrent embedded design where quantitative feasibility data (recording success rates, acceptability ratings) will be integrated with qualitative insights (interviews, open-ended feedback) to provide a comprehensive evaluation of the mobile EEG platform.

Qualitative Component: Semi-structured interviews will explore stakeholder perspectives on feasibility, acceptability, usability, trust, and implementation considerations. Interviews will be conducted with pediatric neurologists before and after device demonstration, and with patient-caregiver dyads before and after the EEG recording session.

Quantitative Component: Pilot EEG recording sessions will assess technical performance, recording quality, and operational metrics. Post-use surveys will quantify acceptability ratings and user experience measures.

Geographic Comparison: Data will be collected at two distinct sites (Houston and El Paso) to capture perspectives across different clinical environments, demographic populations, and geographic contexts within Texas.

The study design prioritizes ecological validity by conducting evaluations in real clinical environments with actual patients and families who have experience with seizure disorders and EEG testing.

Study Population

The study population includes three distinct stakeholder groups: pediatric neurologists, pediatric patients with confirmed seizure disorders, and their primary caregivers. Participants will be recruited from two Texas metropolitan areas with different demographic and geographic characteristics.

Houston Site: Urban academic medical center environment with diverse population and established pediatric neurology services through UTHealth Houston and Texas Children's Hospital.

El Paso Site: Border metropolitan area with predominantly Hispanic population, serving both urban and rural communities through Texas Tech University Health Sciences Center and El Paso Children's Hospital.

This dual-site approach will capture perspectives across different clinical contexts, socioeconomic backgrounds, and cultural environments, enhancing the generalizability of findings to diverse underserved populations.

Vulnerable Populations: This study will include children (ages 2-17) and may include participants with limited English proficiency. Additional protections include:

• Age-appropriate assent procedures for participants 7-17 years

• Certified interpreter services for Spanish-speaking families

• Caregiver presence during all pediatric procedures

• Clear protocols for managing any seizure events during recording

Inclusion Criteria

Pediatric Neurologists:

1. Board-certified or board-eligible pediatric neurology

2. Currently practicing in Houston or El Paso metropolitan areas

3. Regular experience interpreting pediatric EEGs (≥5 per month)

4. Willing to participate in 60-minute interview and device demonstration

5. English fluency sufficient for interview participation

Patients:

1. Ages 2-17 years

2. Confirmed seizure disorder diagnosis in medical record

3. Prior hospital-based EEG testing within past 24 months

4. Medically stable for brief outpatient EEG recording

5. Developmental capacity to cooperate with electrode placement

6. Primary caregiver available to accompany patient

Caregivers:

1. Primary caregiver (parent/guardian) of eligible pediatric patient

2. Present during patient's prior hospital EEG experiences

3. English or Spanish fluency sufficient for interview participation

4. Willing to accompany patient during BC-1 recording session

5. Able to provide informed consent for patient participation

Exclusion Criteria

Patients:

1. Active scalp wounds, infections, or dermatological conditions preventing electrode placement

2. Severe developmental delays or behavioral issues preventing cooperation with procedures

3. Medical instability requiring urgent intervention or hospitalization

4. Current participation in interventional clinical trials

5. Known allergy to electrode gel or adhesive materials

Caregivers:

1. Inability to provide informed consent due to cognitive impairment

2. Primary language other than English or Spanish

3. Unwillingness to be audio-recorded during interviews

Neurologists:

1. Limited pediatric EEG interpretation experience (<1 year)

2. Plans to leave current position during study period

3. Previous research collaboration with BrainCapture company

Recruitment and Enrollment

Neurologist Recruitment:

• Direct outreach to pediatric neurology departments at partner institutions

• Professional network contacts and colleague referrals

• Presentation at local neurology society meetings

• Email invitations through department administrators

Patient-Caregiver Recruitment:

• Clinic-based recruitment during routine neurology follow-up visits

• Electronic medical record screening with physician approval

• Referrals from participating neurologists

• IRB-approved flyers in clinic waiting areas

• Community outreach through epilepsy support groups and advocacy organizations

Identification Process: Research staff will work with clinical teams to identify potentially eligible participants through:

• Scheduled clinic appointment lists

• EMR queries for patients with seizure disorder diagnoses and recent EEG history

• Provider referrals during routine clinical care

• Self-referral through approved recruitment materials

Target Enrollment: 8-10 pediatric neurologists (4-5 per site), 30-40 patient-caregiver dyads (15-20 per site)

Study Procedures

For Pediatric Neurologists:

Single Visit (60 minutes):

1. Informed Consent (5 minutes): Review and sign consent form

2. Pre-demonstration Interview (20 minutes): Semi-structured interview about current EEG practices, perceived barriers to access, initial impressions of mobile EEG concept

3. BC-1 Device Demonstration (15 minutes): Hands-on experience with device setup, recording interface, and data review

4. Post-demonstration Interview (15 minutes): Feedback on device usability, acceptability, implementation considerations

5. Survey Completion (5 minutes): Quantitative acceptability ratings and demographic information

For Patient-Caregiver Dyads:

Single Visit (90 minutes):

1. Informed Consent/Assent (10 minutes): Review procedures with caregiver and age-appropriate explanation for patient

2. Pre-recording Interview with Caregiver (20 minutes): Prior EEG experiences, expectations, initial concerns about mobile EEG

3. BC-1 EEG Recording Session (30 minutes):

• Device setup and electrode application (10 minutes)

• EEG recording with standard activation procedures (15 minutes)

• Device removal and cleanup (5 minutes)

4. Post-recording Interview with Caregiver (20 minutes): Experience feedback, acceptability assessment, implementation preferences

5. Survey Completion (10 minutes): Quantitative ratings and demographic information

EEG Recording Protocol:

• Equipment: BrainCapture-1 device with age-appropriate electrode cap

• Duration: 15-20 minutes of recording time

• Activation Procedures: Eyes open/closed, hyperventilation (if age-appropriate), intermittent photic stimulation

• Monitoring: Continuous supervision by trained research staff

• Quality Control: Real-time signal quality assessment and troubleshooting

Data Collection Elements:

• Technical performance metrics (setup time, signal quality, battery usage)

• Adverse events or equipment malfunctions

• Participant cooperation and comfort levels

• Recording interpretability assessment

Risks Assessment

Risks to Participants:

For EEG Recording Sessions:

• Physical Discomfort: Minimal risk of scalp irritation from electrode gel or cap pressure. Risk mitigation includes using hypoallergenic materials and limiting recording duration.

• Seizure Precipitation: Very low risk that activation procedures (hyperventilation, photic stimulation) could trigger seizures. Risk mitigation includes having trained clinical staff present and emergency protocols available.

• Psychological Distress: Minimal risk of anxiety or discomfort during electrode placement, particularly in young children. Risk mitigation includes caregiver presence, age-appropriate explanation, and ability to discontinue at any time.

• Confidentiality Breach: Risk that personal health information could be inappropriately disclosed. Risk mitigation includes secure data storage, de-identification procedures, and restricted access protocols.

For All Participants:

• Privacy Concerns: Risk that sensitive information shared during interviews could be disclosed. Risk mitigation includes audio file encryption, transcript de-identification, and secure storage procedures.

• Time Burden: Inconvenience of participating in research activities. Risk mitigation includes flexible scheduling, compensation for time, and efficient study procedures.

Risk Classification: This study presents minimal risk to participants. The EEG recording procedures are identical to standard clinical care, and interviews involve topics routinely discussed in healthcare settings.

Emergency Procedures:

• Direct access to pediatric neurology clinical team during recording sessions

• Standard seizure management protocols and emergency equipment available

• Clear procedures for study discontinuation if participants become distressed

Potential Benefits:

Direct Benefits to Participants:

• Access to additional EEG recording that may provide clinical information

• Opportunity to experience potentially beneficial technology before widespread availability

• Contribution to research that may improve care for their condition

Indirect Benefits:

• Knowledge Generation: Findings will inform strategies for expanding access to neurodiagnostic testing in underserved populations

• Healthcare Innovation: Results may accelerate development and implementation of portable diagnostic technologies

• Health Equity: Research may contribute to reducing disparities in neurological care access

• Clinical Practice Improvement: Insights may inform best practices for integrating mobile EEG into clinical workflows

Benefit-Risk Assessment: The potential benefits to participants and society substantially outweigh the minimal risks associated with participation. The research addresses a significant public health need and has the potential to improve care access for vulnerable populations.

Data Collection and Management

Data Sources:

1. Audio-recorded interviews with transcription

2. EEG recordings from BC-1 device

3. Post-use survey responses (electronic and paper)

4. Technical performance logs from recording sessions

5. Demographic and clinical information from participants

Data Storage and Security:

• Electronic Data: Stored on password-protected UTHealth Houston servers with encryption

• Audio Files: Encrypted immediately after recording and stored separately from transcripts

• Paper Forms: Secured in locked filing cabinets with restricted access

• EEG Data: De-identified and stored on secure research drives with backup systems

Identifiers: Limited identifiers will be collected including:

• Study ID numbers (primary identifier for all data)

• Age ranges (not exact birthdates)

• Geographic location (city level only)

• Clinical characteristics relevant to seizure disorders

De-identification Process:

• Direct identifiers removed from all analysis datasets

• Audio recordings transcribed with removal of identifying information

• Linking logs maintained separately with restricted access

• Participants referenced only by study ID numbers in all analyses

Data Access:

• Principal Investigator and designated research coordinators only

• All staff complete HIPAA and research ethics training

• Signed confidentiality agreements for all team members

• Audit trail maintained for all data access

Data Sharing:

• No identifiable data will be shared with external entities

• De-identified aggregate results may be shared with BrainCapture for device improvement (per data use agreement)

• No individual participant data will be provided to device manufacturer

• All external data sharing governed by formal agreements reviewed by UTHealth legal

REDCap Database:

• UTHealth Houston REDCap instance for survey data collection

• User authentication and role-based access controls

• Automated audit trails and data validation checks

• Regular data backups and security monitoring

Record Retention:

• Study records maintained for 6 years after study completion per UTHealth policy

• Audio recordings destroyed after transcription and verification (within 1 year)

• De-identified datasets maintained indefinitely for potential secondary analyses

• Linking logs destroyed 3 years after study completion

Statistics

Sample Size Justification: This pilot study employs a pragmatic sample size approach focused on generating preliminary evidence for future larger studies. The target sample size of 16-20 neurologists and 30-40 patient-caregiver dyads is designed to:

• Achieve thematic saturation in qualitative interviews (typically reached with 15-20 participants per stakeholder group)

• Provide sufficient precision for acceptability proportion estimates (95% CI ±15% with n=30)

• Enable preliminary assessment of technical feasibility across diverse participants

• Support planning for future adequately powered studies

Primary Analysis: Hypothesis Testing: The study will test the primary hypothesis that ≥80% of clinicians and ≥80% of patients/caregivers will rate overall acceptability ≥4 on a 5-point Likert scale, and that ≥85% of EEG recordings will be successful (≥10 minutes interpretable data).

Statistical Methods:

• Acceptability Analysis: Calculate proportions with 95% confidence intervals using exact binomial methods

• Feasibility Analysis: Descriptive statistics for technical performance metrics

• Comparison Analysis: Chi-square tests for categorical variables, t-tests or Mann-Whitney U for continuous variables

• Site Comparison: Compare outcomes between Houston and El Paso using appropriate tests for independent samples

Qualitative Analysis:

• Thematic Analysis: Using Dedoose software with framework analysis approach

• Coding: Independent coding by two researchers with inter-rater reliability assessment

• Triangulation: Integration of qualitative themes with quantitative findings using joint displays and meta-inferences

Secondary Analyses:

• Clinical Agreement: Calculate kappa coefficients for EEG interpretation agreement (where hospital comparisons available)

• Predictors of Acceptability: Exploratory logistic regression to identify demographic or clinical factors associated with high acceptability ratings

• Implementation Factors: Thematic analysis of barriers and facilitators identified across stakeholder groups

Missing Data:

• Approach: Complete case analysis for primary outcomes

• Sensitivity Analysis: Multiple imputation for secondary analyses if missing data >10%

• Documentation: Detailed tracking of reasons for missing data

Significance Level: α = 0.05 for all statistical tests Software: GraphPad Prism for quantitative analyses, Dedoose for qualitative analyses, R for advanced statistical modeling

Safety Monitoring

Expected Adverse Events: Based on standard EEG procedures, the following minor adverse events may occur:

• Mild scalp irritation from electrode gel (expected frequency: <5%)

• Transient discomfort from electrode cap (expected frequency: <10%)

• Anxiety or distress during electrode placement (expected frequency: <5% in pediatric participants)

Adverse Event Assessment and Grading:

• Mild: Transient discomfort not requiring intervention

• Moderate: Symptoms requiring minor intervention or causing temporary limitation

• Severe: Symptoms requiring immediate medical attention or study discontinuation

Safety Monitoring Plan:

• Real-time Monitoring: Trained research staff present during all procedures

• Documentation: Immediate recording of any adverse events in study records

• Clinical Support: Direct access to pediatric neurology clinical team during recording sessions

• Emergency Protocols: Standard seizure management procedures and equipment available

Unanticipated Problems Reporting: Unanticipated problems will be identified as events that are:

1. Unexpected in nature, severity, or frequency

2. Related or possibly related to study participation

3. Suggest greater risk than previously known

Reporting Timeline:

• Immediate: Severe adverse events reported to PI within 2 hours

• 24 Hours: All adverse events documented and reviewed by PI

• 5 Business Days: Serious unanticipated problems reported to IRB

• Annual: Summary safety reports in continuing review

Protocol Deviation Monitoring:

• Major Deviations: Events potentially impacting participant safety or study integrity

• Minor Deviations: Events not affecting safety or scientific validity

• Documentation: All deviations recorded with corrective action plans

• Reporting: Major deviations reported to IRB per institutional policy

Data Safety Monitoring:

• Weekly Team Meetings: Review of all adverse events and protocol deviations

• Monthly Reports: Safety summary to PI and research team

• Interim Analysis: Safety review at 50% enrollment completion

• External Review: Not required for this minimal risk study

Ethics

IRB Approval: This study will be initiated only after approval from the UTHealth Houston Committee for the Protection of Human Subjects (CPHS). Additional approvals will be sought from partner institutions as required:

• Texas Children's Hospital Clinical Research Core

• Texas Tech University Health Sciences Center IRB

• Memorial Hermann Health System Research Institute (if applicable)

Informed Consent Process:

For Pediatric Neurologists:

• Responsible Person: PI or designated research coordinator

• Location: Private office or conference room at clinical site

• Process: Individual consent discussion with opportunity for questions

• Documentation: Signed consent form required for participation

• Time: Minimum 30 minutes provided for review before consent decision

• Understanding Assessment: Teach-back method to confirm comprehension

For Patient-Caregiver Dyads:

• Responsible Person: Trained research coordinator with clinical background

• Location: Private clinical room with caregiver and patient comfort accommodations

• Process:

• Detailed explanation to caregiver with child-appropriate explanation to patient

• Age-appropriate assent obtained for children 7-17 years

• Opportunity for family discussion and questions

• Documentation: Signed consent (caregiver) and assent forms (age-appropriate)

• Time: Minimum 45 minutes provided for review and family discussion

• Language: Certified interpreter services available for Spanish-speaking families

• Understanding Assessment: Open-ended questions to assess comprehension

Coercion Prevention:

• Recruitment conducted by research staff, not treating physicians

• Clear emphasis that participation is voluntary and will not affect clinical care

• No coercive language or undue inducements

• Participants may withdraw at any time without penalty

• Alternative options clearly explained (standard care remains available)

Privacy Protection:

• Consent discussions in private settings

• Confidential handling of all personal information

• Separate storage of consent forms and study data

• Limited access to participant information by study team only

Waiver Considerations: No waiver of consent or documentation is requested. All participants will provide appropriate informed consent/assent with full documentation as required by federal regulations and institutional policy.

Conflict of Interest Statement

All study personnel have submitted current financial disclosure statements to UTHealth Houston within the past year. No study team members have financial interests related to BrainCapture technology or competing EEG device manufacturers.

BrainCapture Relationship: The study involves evaluation of the BrainCapture-1 device; however, no study personnel receive financial compensation from BrainCapture beyond the standard purchase price for research equipment. Technical support provided by BrainCapture is part of their standard customer service and does not constitute a financial relationship.

Funding Independence: This study is funded by Health in Your Hands, a 501(c)(3) non-profit organization independent from any device manufacturers. Research decisions and publication rights remain entirely with the study team. The funding mechanism chosen was experiment.com, a crowdfunding platform for peer-reviewed research studies.

Data Handling and Record Keeping

Source Document Access:

• All study records are maintained at UTHealth Houston with controlled access

• Source documents include consent forms, case report forms, audio recordings, and EEG data files

• Access limited to PI, designated coordinators, and authorized regulatory personnel

• Audit trail maintained for all document access

Participant Confidentiality Procedures:

During Study:

• Participants identified by unique study ID numbers in all research activities

• Linking logs stored separately from study data with restricted access

• Audio recordings stored on encrypted drives with password protection

• Paper documents secured in locked filing cabinets

Data Storage Locations:

• Electronic Data: UTHealth Houston secure servers with regular backups

• Audio Files: Encrypted external drives in locked research office

• Paper Documents: Locked filing cabinets in secure research space

• EEG Data: Secure research drives with automatic backup systems

Access Control:

• Password-protected systems with user authentication

• Role-based access permissions limiting data exposure

• Regular access reviews and permission updates

• Signed confidentiality agreements for all personnel

Data Retention:

• Study records maintained for 6 years after study completion

• Audio recordings destroyed after transcription verification (within 12 months)

• De-identified data may be retained indefinitely for secondary research

• Participant withdrawal results in destruction of all associated data

External Data Sharing: No identifiable data will be shared outside UTHealth Houston. If de-identified aggregate data are shared for device improvement or collaboration:

• Formal data use agreements required

• IRB approval obtained for any data sharing

• No individual participant information provided

• Aggregate results only with statistical disclosure controls

Quality Control and Assurance

Data Accuracy Procedures:

• Double Data Entry: Critical variables entered independently by two staff members

• Range Checks: Automated validation in REDCap database

• Source Verification: Regular comparison of database entries to source documents

• Real-time Quality Control: Review of data completeness during collection

Interview Quality Assurance:

• Interviewer Training: Standardized training program for all interview staff

• Recording Quality: Audio quality checks before each interview session

• Transcription Accuracy: 10% of transcripts verified by independent review

• Coding Reliability: Inter-rater agreement assessment for qualitative coding

EEG Recording Quality Control:

• Technical Training: Comprehensive training on BC-1 device operation

• Real-time Monitoring: Signal quality assessment during recording sessions

• Equipment Calibration: Regular device performance checks and maintenance

• Data Integrity: Automated file validation and backup procedures

Self-Assessment Activities:

• Weekly Team Meetings: Review of data collection progress and quality issues

• Monthly Audits: Random selection of 10% of records for completeness review

• Quarterly Reviews: Comprehensive assessment of protocol adherence and data quality

• Annual Evaluation: Overall study conduct review with corrective action planning

Third-Party Monitoring: Given the minimal risk nature of this observational study and limited funding, formal third-party monitoring is not planned. However, the study is subject to:

• UTHealth Houston IRB continuing review requirements

• Potential regulatory audit by institutional compliance officers

• Funder review of study conduct and progress reports

Corrective Actions:

• Protocol Deviations: Immediate corrective action plans and staff retraining

• Data Quality Issues: Enhanced verification procedures and system improvements

• Equipment Problems: Immediate technical support contact and backup procedures

• Staff Performance: Additional training or role modifications as needed

Publication Plan

Manuscript Preparation: Primary results will be prepared for publication in peer-reviewed journals focusing on:

Goal for Open-Access Paper: Feasibility and acceptability findings in a pediatric neurology or health services research journal, OPEN ACCESS journal ONLY. Funding assistance will be sought from the Office of Global Health Initiatives

Authorship:

• Authorship will follow International Committee of Medical Journal Editors (ICMJE) guidelines

• All contributors meeting authorship criteria will be included

• Student researchers will be prioritized for first authorship where appropriate

• Several members of student-led team may qualify for sharing first-author status

• Acknowledgment section will recognize all study contributors

Data Sharing:

• De-identified datasets will be made available through appropriate repositories following publication

• Qualitative interview guides and quantitative measures will be shared to support replication

• Aggregate results may be shared with clinical partners and advocacy organizations

Results Dissemination:

• Academic Conferences: Presentation at pediatric neurology, general neurology research, and global health conferences

• Clinical Communication: Results shared with participating clinicians and institutions

• Community Engagement: Summary findings provided to epilepsy advocacy organizations and community partners

• Policy Implications: Briefings prepared for relevant healthcare policy stakeholders

Return of Results to Participants:

• Aggregate study findings will be provided to all participants who express interest

• Individual EEG results will not be provided as this is a research study, not clinical care

• Clinical findings that require immediate attention will be communicated to participants' treating physicians with appropriate consent

• Summary newsletter with key findings will be distributed to all participants

Timeline:

• Preliminary Results: Conference abstracts submitted within 6 months of study completion

• Primary Manuscript: Submitted within 12 months of study completion

• Results Dissemination: Community and participant reports within 18 months

Protocol Amendments

Amendment History:

Version	Date	Summary of Changes
v.1.0	August 24, 2025	Initial protocol version

Future Amendment Process:

• All protocol modifications will be submitted to IRB before implementation

• Major amendments affecting participant safety or study integrity will require new consent from enrolled participants

• Minor administrative changes will be documented and reported in continuing review

• Version control maintained with clear documentation of all changes

References

1. World Health Organization. Epilepsy: A Public Health Imperative. Geneva: World Health Organization; 2019.

2. Coleman ER, Laux L, Cate TR, et al. Access to neurological care in rural areas. Neurol Clin Pract. 2002;12(4):345-352.

3. Mbuba CK, Ngugi AK, Newton CR, Carter JA. The epilepsy treatment gap in developing countries: a systematic review of the magnitude, causes, and intervention strategies. Epilepsia. 2012;53(9):1527-1540.

4. Buchalter JR, Shan G, Martin JE, et al. Geographic disparities in pediatric epilepsy care access across the United States. Epilepsia. 2022;63(8):2089-2098.

5. Tu Y, Wang S, Li X, et al. Infrastructure access inequalities and epilepsy burden in low- and middle-income countries. Nat Hum Behav. 2025;9:123-134.

6. Beghi E, Giussani G, Abd-Allah F, et al. Global, regional, and national burden of epilepsy, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019;18(4):357-375.

7. Louis S, Chen L, Patel AA, et al. County-level variation in epilepsy prevalence and neurology care access in the United States. Epilepsy Behav. 2024;152:109634.

8. Maleki N, Rodriguez-Ruiz A, Wang X, et al. Hospital density in sixty-minute service areas of children's hospitals: geographic access disparities. Pediatr Emerg Care. 2024;40(3):189-195.