Evidence map›Paper›PMID 38366862›Full record

ArticleEpilepsia2024

Minimum clinical utility standards for wearable seizure detectors: A simulation study.

Daniel M Goldenholz, Philippa J Karoly, Pedro F Viana, Ewan Nurse, Tobias Loddenkemper, Andreas Schulze-Bonhage, Solveig Vieluf, Elisa Bruno, Mona Nasseri, Mark P Richardson and 2 more

Open access · greenAbstract read
In one paragraph

Article in Epilepsia, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
2.7field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 7 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 7 institutions in 5 countries.

Daniel M GoldenholzDepartment of Neurology, Harvard Medical School, Boston, Massachusetts, USA.ORCID https://orcid.org/0000-0002-8370-2758
Philippa J KarolyDepartment of Neurology, University of Melbourne, Melbourne, Victoria, Australia.ORCID https://orcid.org/0000-0002-9879-5854
Pedro F VianaSchool of Neuroscience, Institute of Psychiatry, Psychology, and Neuroscience, King's College London, London, UK.ORCID https://orcid.org/0000-0003-0861-8705
Ewan NurseSeer Medical, Melbourne, Victoria, Australia.ORCID https://orcid.org/0000-0001-8981-0074
Tobias LoddenkemperDepartment of Neurology, Harvard Medical School, Boston, Massachusetts, USA.
Andreas Schulze-BonhageEpilepsy Center, University Medical Center Freiburg-University of Freiburg, Freiburg, Germany.ORCID https://orcid.org/0000-0003-2382-0506
Solveig VielufDepartment of Neurology, Harvard Medical School, Boston, Massachusetts, USA.
Elisa BrunoSchool of Neuroscience, Institute of Psychiatry, Psychology, and Neuroscience, King's College London, London, UK.ORCID https://orcid.org/0000-0001-8166-1190
Mona NasseriDepartment of Neurology, Mayo Clinic, Rochester, Minnesota, USA.
Mark P RichardsonSchool of Neuroscience, Institute of Psychiatry, Psychology, and Neuroscience, King's College London, London, UK.ORCID https://orcid.org/0000-0001-8925-3140
Benjamin H BrinkmannDepartment of Neurology, Mayo Clinic, Rochester, Minnesota, USA.ORCID https://orcid.org/0000-0002-2392-8608
M Brandon WestoverDepartment of Neurology, Harvard Medical School, Boston, Massachusetts, USA.
Beth Israel Deaconess Medical Center · USBoston Children's Hospital · USKing's College London · GBMayo Clinic · USThe University of Melbourne · AUUniversity of Freiburg · DEUniversity of Lisbon · PT

Funding

Institutional Career Development CoreKL2TR002542 · NCATS · HARVARD MEDICAL SCHOOL · PI BREDELLA, MIRIAM ANTOINETTE, RUTKOVE, SEWARD B. · 2018 to 2022
$8.7M
Data-Driven Sleep Biomarkers of Brain Health, Heart Health, and MortalityR01HL161253 · NHLBI · BETH ISRAEL DEACONESS MEDICAL CENTER · PI CLIFFORD, GARI DAVID, MIGNOT, EMMANUEL J · 2022 to 2025
$8.3M
Automated Seizure Detection for Home Seizure Monitoring with Epilog SensorsU44NS121562 · NINDS · EPITEL, INC. · PI LEHMKUHLE, MARK J. · 2021 to 2025
$6.3M
Comparative Safety of Seizure Prophylaxis within the Medicare ProgramR01AG073410 · NIA · MASSACHUSETTS GENERAL HOSPITAL · PI Lidia Maria Veras Rocha de Moura · 2021 to 2026
$4.1M
Low Neurophysiologic Resistance to Anesthetics as a Marker of Preclinical/Prodromal Alzheimer's Disease and Neurovascular Pathology, Delirium risk and InattentionR01AG073598 · NIA · STANFORD UNIVERSITY · PI Miles Berger · 2022 to 2026
$3.8M
Integrative Motor Activity Biomarker for the Risk of Alzheimer's RiskRF1AG064312 · NIA · BRIGHAM AND WOMEN'S HOSPITAL · PI HU, KUN · 2019 to 2019
$3.6M
Multimodal Network Connectivity Architecture (MOCA) of the Brain and its Role in the Recovery of Consciousness in Comatose Cardiac Arrest PatientsR01NS102574 · NINDS · MASSACHUSETTS GENERAL HOSPITAL · PI GREER, DAVID MATTHEW, WU, ONA · 2018 to 2022
$3.4M
Investigation of Sleep in the Intensive Care Unit (ICU-SLEEP)R01NS102190 · NINDS · MASSACHUSETTS GENERAL HOSPITAL · PI WESTOVER, MICHAEL BRANDON · 2018 to 2022
$3.2M
Prospective Validation of Neurophysiologic Outcome Prediction in Acute Brain InjuryR01NS126282 · NINDS · BETH ISRAEL DEACONESS MEDICAL CENTER · PI Aaron F Struck, Michael Brandon Westover · 2023 to 2026
$2.9M
Big Data and Deep Learning for the Interictal-Ictal-Injury ContiuumR01NS107291 · NINDS · MASSACHUSETTS GENERAL HOSPITAL · PI WESTOVER, MICHAEL BRANDON · 2018 to 2022
$2.8M
Neuroscience Resident Research ProgramUE5NS065743 · NINDS · MASSACHUSETTS GENERAL HOSPITAL · PI SYDNEY S CASH, Ziv Williams · 2024 to 2026
$2.6M
Establishing a Brain Health Index from the Sleep ElectroencephalogramRF1NS120947 · NINDS · MASSACHUSETTS GENERAL HOSPITAL · PI WESTOVER, MICHAEL BRANDON · 2021 to 2021
$2.4M
NCATS NIH HHS KL2 TR002542NHLBI NIH HHS R01 HL161253NIA NIH HHS R01 AG073410NIA NIH HHS R01 AG073598NIA NIH HHS RF1 AG064312NINDS NIH HHS K23 NS124656NINDS NIH HHS K23NS124656NINDS NIH HHS KL2TR002542NINDS NIH HHS R01AG073410NINDS NIH HHS R01AG073598NINDS NIH HHS R01HL161253NINDS NIH HHS R01 NS102190NINDS NIH HHS R01NS102190NINDS NIH HHS R01 NS102574NINDS NIH HHS R01NS102574NINDS NIH HHS R01 NS107291NINDS NIH HHS R01NS107291NINDS NIH HHS R01 NS126282NINDS NIH HHS R01NS126282NINDS NIH HHS RF1AG064312NINDS NIH HHS RF1 NS120947NINDS NIH HHS RF1NS120947NINDS NIH HHS U44 NS121562NINDS NIH HHS U44NS121562NINDS NIH HHS UE5 NS065743NINDS NIH HHS UG3 NS123066NINDS NIH HHS UG3NS123066NINDS NIH HHS UH3 NS123066
6 · The paper itself

Abstract

objectiveEpilepsy management employs self-reported seizure diaries, despite evidence of seizure underreporting. Wearable and implantable seizure detection devices are now becoming more widely available. There are no clear guidelines about what levels of accuracy are sufficient. This study aimed to simulate clinical use cases and identify the necessary level of accuracy for each.

methodsUsing a realistic seizure simulator (CHOCOLATES), a ground truth was produced, which was then sampled to generate signals from simulated seizure detectors of various capabilities. Five use cases were evaluated: (1) randomized clinical trials (RCTs), (2) medication adjustment in clinic, (3) injury prevention, (4) sudden unexpected death in epilepsy (SUDEP) prevention, and (5) treatment of seizure clusters. We considered sensitivity (0%-100%), false alarm rate (FAR; 0-2/day), and device type (external wearable vs. implant) in each scenario.

resultsThe RCT case was efficient for a wide range of wearable parameters, though implantable devices were preferred. Lower accuracy wearables resulted in subtle changes in the distribution of patients enrolled in RCTs, and therefore higher sensitivity and lower FAR values were preferred. In the clinic case, a wide range of sensitivity, FAR, and device type yielded similar results. For injury prevention, SUDEP prevention, and seizure cluster treatment, each scenario required high sensitivity and yet was minimally influenced by FAR. SIGNIFICANCE: The choice of use case is paramount in determining acceptable accuracy levels for a wearable seizure detection device. We offer simulation results for determining and verifying utility for specific use case and specific wearable parameters.

Indexed as

EpilepsyEpilepsy, GeneralizedSudden Unexpected Death in EpilepsyWearable Electronic DevicesElectroencephalographyHumansSeizuresclinical trialcomputationinjuryseizure clustersimulationSUDEPwearable electronic devices

Identifiers

PMID38366862
PMCPMC11018505
OpenAlexW4391897298

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.