Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

NOT YET RECRUITING

NCT07835594

Studying Heart Rhythms With a Wearable Sensor to Detect and Predict Seizures in People With Epilepsy

Sponsor: Acibadem University

View on ClinicalTrials.gov

Summary

The goal of this observational study is to understand heart rhythm changes in adults with epilepsy. It will also explore whether computer programs can use heart recordings to detect or predict seizures. The study will include 20 adults with temporal lobe epilepsy and 20 healthy volunteers. Participants with epilepsy will have ongoing seizures despite treatment with at least two suitable medicines. All participants will be 18 years or older. In temporal lobe epilepsy, seizures start in a specific region of the brain. These seizures may spread to both sides of the brain, causing muscle stiffening and rhythmic jerking. Researchers will focus on these spreading seizures when developing seizure detection and prediction methods. The main questions are: * How do heart rate and heartbeat timing differ between people with and without epilepsy? * How do these measures change before, during, and after seizures? * Can computer programs learn patterns in heart recordings to detect seizures or predict them before they start? Researchers will compare heart rate and heart rate variability between the two groups. Heart rate variability describes changes in the time between one heartbeat and the next. They will compare recordings during rest, wakefulness, and sleep. Participants will: * Wear a fabric chest band that records the heart's electrical activity. * Have brain activity recorded through sensors on the scalp, alongside video recording. * Rest quietly while awake for one hour during the recording period. Participants with epilepsy will have recordings during their usual hospital monitoring. Healthy volunteers will have 24 hours of recording at the same hospital. Researchers will use the brain recordings and video to identify when seizures happen. They will develop and test computer programs that learn patterns in the heart recordings.

Official title: Heart Rhythm Analysis, Seizure Detection and Prediction Using a Textile-Based Wearable Sensor in Patients With Epilepsy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

Start Date

2026-10-15

Completion Date

2028-10-15

Last Updated

2026-09-23

Healthy Volunteers

Yes

Conditions

Epilepsy, Temporal Lobe Drug Resistant Epilepsy

Interventions

DEVICE

Textile-based wearable electrocardiography

A textile-based wearable chest band will record electrocardiography (ECG) simultaneously with video-EEG. Epilepsy participants will wear the device during their clinically indicated inpatient monitoring, without changes to routine monitoring duration or clinical care. Healthy volunteers will undergo 24 hours of recording at the same hospital. Both groups will complete a standardized one-hour awake resting recording. ECG data will be used for heart rate and heart rate variability analyses and development and offline evaluation of seizure detection and prediction models. Study recordings and model outputs will not guide participants' medical care.

Inclusion Criteria: Epilepsy group: * Age 18 years or older. * Diagnosis of temporal lobe epilepsy and admission to the epilepsy monitoring unit for video-electroencephalography (video-EEG) monitoring. * Ongoing seizures despite treatment with at least two appropriately selected and tolerated antiseizure medicines at adequate doses and for adequate durations. * History or clinical suspicion of focal to bilateral tonic-clonic seizures. * Provision of written informed consent. Healthy volunteer group: * Age 18 years or older. * No known epilepsy or history of seizures. * Provision of written informed consent. Exclusion Criteria: Epilepsy group: * A neurodevelopmental disorder that prevents cooperation or following instructions. * A physical condition that prevents placement of the chest band. * Inability to securely attach the electrocardiography (ECG) or EEG sensors for reliable recording. * Absence of an epilepsy diagnosis or identification of psychogenic nonepileptic seizures. * Pregnancy or breastfeeding. * An implanted cardiac or neurostimulation device, such as a pacemaker, vagus nerve stimulator (VNS), or deep brain stimulation (DBS) device. * Allergy, skin sensitivity, or a skin lesion that prevents use of the electrodes or chest band. * A concomitant disease or medication use that may substantially affect heart rate or heart rate variability (HRV). * Having been diagnosed with major depressive disorder. Healthy volunteer group: * A history of epilepsy or seizures. * Cardiovascular disease, a condition that may cause autonomic neuropathy, or medication use that may substantially affect heart rate or HRV. * Allergy, skin sensitivity, or a skin lesion that prevents use of the electrodes or chest band. * Having been diagnosed with major depressive disorder. * Pregnancy or breastfeeding. Analysis-specific provisions: The absence of a recorded target seizure during monitoring will not by itself exclude an epilepsy participant from the study; these recordings may contribute to heart rate and HRV analyses. Recordings from participants with one or two target seizures may also contribute to patient-independent machine learning models. Patient-specific machine learning models require at least three recorded target seizures from the same participant.

Locations (1)

Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital

Istanbul, Turkey (Türkiye)