A Novel, Multimodal Wearable System for Monitoring Generalized Seizures and Cardiorespiratory Function
Abstract number :
1.503
Submission category :
2. Translational Research / 2B. Devices, Technologies, Stem Cells
Year :
2024
Submission ID :
1466
Source :
www.aesnet.org
Presentation date :
12/7/2024 12:00:00 AM
Published date :
Authors :
Presenting Author: Jay Shah, PhD – Neurava Inc.
Vivek Ganesh, PhD – Neurava Inc.
Trevor Meyer, PhD – Neurava Inc.
Ayush Umrani, BS – Neurava Inc.
Kshitij Shah, BS – Neurava Inc.
Deidre Dragon, BS – University of Iowa
Kelly Lowen, CCRP – Vanderbilt University Medical Center
Norma Hupp, R EEGT/CLTM – University of Texas Health Science Center at Houston
Sandhya Rani, PhD – University of Texas Health Science Center at Houston
Gorbachev Jowah, MD – University of Texas Health Science Center at Houston
Olga Rodziyevska, MS, PA-C – McGovern Medical School, The University of Texas Health Science Center at Houston
Janaei Phillips, RN, MSN – University of Texas Health Science Center at Houston
Lucy Mendoza, CCRP – University of Cincinnati
Patrick Newell, BS – University of Cincinnati
Alex Rivera, MS, CRC II – Pediatrix Neurology and Epilepsy of Florida
Kathryn Skiles Bruner, NRCMA, CRC I – Pediatrix Neurology and Epilepsy of Florida
Denise Hubert, Sr. CRC – Pediatrix Neurology and Epilepsy of Florida
Jennifer Mullett, BSN RN, BC CCRP – Riley Children’s Hospital
Shaiv Mehra, BS – Neurava Inc.
Arin Asawa, BS – Neurava Inc.
Samuel Simonian, BS – Neurava Inc.
Derryl Miller, MD – Riley Children’s Hospital
Rup Sainju, MBBS – University of Iowa
Brian Gehlbach, MD – University of Iowa
Gretchen Von Allmen, MD – McGovern Medical School, The University of Texas Health Science Center at Houston
Shilpa Reddy, MD, MMHC – Vanderbilt University Medical Center
Michael Ciliberto, MD – University of Iowa Hospitals and Clinics, Iowa City, IA, USA
Makram Obeid, MD – Riley Children’s Hospital
Ronald Davis, MD, FAES – Pediatrix Neurology and Epilepsy of Florida
Michael Privitera, MD – University of Cincinnati
William Nobis, MD, PhD – Vanderbilt University Medical Center
Samden Lhatoo, MD, FRCP – University of Texas Health Science Center at Houston
George Richerson, MD, PhD – University of Iowa
Rationale: The landmark MORTEMUS study and several follow-up studies demonstrated that sudden unexpected death in epilepsy (SUDEP) is typically a cardiorespiratory collapse that occurs during or directly after a generalized convulsive seizure (GCS). Monitoring for cardiorespiratory dysfunctions may therefore be critical in potentially preventing SUDEP. We developed a multimodal wearable system with devices on the arm and neck that monitor for GCS and cardiorespiratory function. The arm wearable’s capability to detect GCS was previously validated on 30 adults with epilepsy, resulting in positive usability scores and detection capabilities consistent with other monitoring devices available on the market. Here we report preliminary findings from a study of both wearables on adults and children with epilepsy.
Methods: This is a multicenter, prospective study conducted using both Neurava wearables in epilepsy monitoring units (EMUs) at Univ. of Iowa, Vanderbilt Univ. Medical Center, Univ. of Texas Health Science Center at Houston, Univ. of Cincinnati, Pediatrix Neurology and Epilepsy of Florida, and Riley Children’s Hospital. The subjects are admitted to the EMUs as part of their normal clinical care. People older than 6 years with confirmed epilepsy and suspected of having GCS were included. The primary outcome of the study is to validate the neck and arm wearables’ capability to monitor cardiorespiratory function and detect GCS relative to gold-standard, time-synced video-electroencephalography (EEG), electrocardiography (ECG), respiratory inductance plethysmography, and SpO2 data with physician annotations. The secondary outcome is capturing usability scores related to the subjects’ experiences with the wearables, obtained by asking subjects to complete a 6-point Likert scale questionnaire.
Results: To date, 40 subjects (29 adults, 11 children, 47.5% female, median age = 29.2 yrs) have worn the Neurava wearable system. 10 GCS have been captured with the full system. On average, the subjects agreed (score > 3.5) that they would wear the full system at home during the night (score = 3.7) and would recommend it to others (score = 3.9). Preliminary work incorporating new data into our existing seizure prediction algorithm resulted in a positive percent agreement (PPA) of 88.9% and a false alarm rate (FAR) of 0.677/day. Preliminary results of heart and respiration rate tracking algorithms from a night containing GCSs showed mean absolute errors (MAE) of 2.69 beats/min [95%CI: 2.14-3.24] and 2.65 breaths/min [95%CI: 2.59-2.71], respectively.
Conclusions: Preliminary results demonstrate that Neurava’s wearables can successfully monitor cardiorespiratory function and detect GCS in adults and children with epilepsy. The wearables will provide people with epilepsy, caregivers, and physicians with accurate multimodal cardiorespiratory data and GCS detection and monitoring. This system may help mitigate the risk of SUDEP by alerting for life-threatening events and eventually stratify SUDEP risk, including potentially identifying those at elevated risk.
Funding: This study is funded by Neurava Inc.
Translational Research