Testing a Novel Dry Electrode Headset for Electroencephalography Telehealth
Testing a Novel Dry Electrode Headset for Electroencephalography Telehealth
批准号:
10595484
负责人:
Jonathan Jacob Halford
金额:
$0.0万
依托单位国家:
美国
项目类别:
财政年份:
2022
资助国家:
美国
项目状态:
未结题
起止时间:
2022-03-01 至 2026-02-28
关键词:
AddressAmbulatory Care FacilitiesAmplifiersAppointmentBlindedBoard CertificationCaringClinicClinicalClinical TrialsCommunitiesComputer softwareCost SavingsCosts and BenefitsDataDevicesDiagnostic ProcedureDiscipline of NursingDrynessElectrodesElectroencephalographyEpilepsyEquipmentEquipment and SuppliesEvaluationEventFDA approvedHeadHealth Services AccessibilityHealthcare SystemsHourImprove AccessInternetInterviewLocationMeasuresMedical centerMethodologyMethodsMinorMissionModalityMorphologic artifactsNeurologicNeurologistNursesOutpatientsPatient CarePatientsPatternPerformancePreparationProbabilityProceduresRandomized, Controlled TrialsRecording of previous eventsResearchResearch PersonnelResearch PriorityResearch ProposalsResearch SubjectsRural CommunityRural HealthScheduleSeizuresSignal TransductionSiteSkinSystemTelemedicineTestingTimeTrainingTravelVeteransVisitWagesWait Timecostepileptiformimprovedinnovationnoveloutreach programprocedure costprospectiverecruitremote locationrural arearural residencetelehealthtransmission process
中文摘要
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英文摘要
Background: Many Veterans live far away from a VAMC with substantial electroencephalography (EEG)
expertise. Travel is difficult for epilepsy patients since they often cannot drive. We propose to study a novel dry
electrode system (DES) which does not require EEG technologists to operate and can be operated by a nurse
assistant. This DES integrates the electrodes and EEG amplifier into a compact headset which is easily placed
on the head (without skin preparation) and could be used in an epilepsy telemedicine outreach program along
with clinical interviews. We have performed three preliminary studies with DES headsets. In our first two
studies in 33 Veterans performed at a VAMC, we found that the DES was quick to apply, taking only 5-6
minutes to put on by a research subject with the assistance of a neurologist. Subjects preferred the DES
headset over the standard EEG system (SES). In our third study a nurse performed 30 DES recordings in a VA
community based outpatient clinic (CBOC). Rating of the EEG recordings on a five point scale by three board
certified clinical EEG experts (after automated EEG artifact reduction was applied to the recordings) showed
that all 30 recordings were of acceptable quality (rated 3 out of 5 or higher with some artifact present) and 18
of 30 recordings were of good quality (rate 4 or above with only minor artifacts present).
Significant Impact: This study will improve access of Veterans with epilepsy living in rural areas to the most
important diagnostic procedure for the care of patients with epilepsy: the routine EEG. Being able to perform
routine EEG in CBOCs can decrease cost to the VA system since DES EEG systems are less expensive and
because Veterans will not have to travel to VAMCs for EEG. This study will also test the DES system to make
sure it can record epileptiform transients (ETs), the pattern in EEG which indicates that patients have epilepsy.
Innovation: This study is innovative because it will use a new recording system for EEG that just got FDA
approval. This new DES EEG recording system provides a method for recording EEG which is cheaper and
much easier to perform than conventional EEG. This study is also innovative because it will test for the first
time if a DES can reliably record ETs. (The FDA approval for the DES system was based on EEG signal
quality only and not whether it could reliably detect ETs.) The study will also use a new FDA-approved method
for automatically removing artifactual signals which can obscure DES EEG recordings.
Specific Aims: The first aim of the project is to test the ability of the DES to record ETs versus the SES. The
second aim is to collect data on appointment wait time, appointment cancellation rate, and procedure cost of
DES versus SES to project the improvement in Veteran access and potential cost-benefit of DES EEG
performed in CBOCs versus SES EEG performed in VAMCs.
Methodology: This is a randomized controlled trial which will be performed at three sites: the Charleston
VAMC, Durham VAMC, and Miami VAMC. For Specific Aim 1, 400 Veterans (200 with a history of an abnormal
EEGs in which ETs were recorded and 200 prospective Veterans scheduled for an outpatient EEG) will be
recruited to have a DES EEG procedure and a SES EEG procedure performed during a single study visit in a
VAMC by an EEG technologist. Each EEG recording will be interpreted and rated for technical quality by three
study investigators, who will also annotate the location of ETs in each EEG recording. The fraction of EEGs
which demonstrate ETs and the technical quality ratings will be compared. For Specific Aim 2, data will be
collected on 300 prospective Veterans scheduled for an outpatient routine EEG, including appointment
cancellation rate, travel cost, and other patient factors. Costs for EEG equipment/supplies as well as technician
effort/salary and nurse and nurse assistant effort/salary will also be collected. This will be used to project the
potential improvement in patient access and potential cost savings of a nurse or nurse technician performing
outpatient DES EEG in a CBOC versus an EEG technician performing outpatient SES EEG in a VAMC.
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