Participants are allowed to enter the trial (to use Embrace+Alert app) whether or not they have epilepsy. People without epilepsy may use Alert in this trial even though they are not expected to have seizures, as long as they are willing to mark false positives. Since many people with epilepsy live active lives and appear perfectly healthy outwardly, it is important that their active lifestyle data not trigger false alarms. Allowing healthy participants without epilepsy to contribute active lifestyle data helps us make the detection algorithm even stronger and better.

Epilepsy

Participants will wear an Embrace smartwatch to collect data, and will provide survey/diary information on the occurrence of seizures. The device sends data to the Alert app, which issues either true detections or false alarms when it detects a possible convulsive seizure. Participants are asked to either cancel (in real time) or mark (at a later time) all false alarms using the Alert app.

Embrace + Alert App

Embrace: Seizure Characterization

Characterizing Sleep, Stress, and Seizures in Daily Life: An Internet-based Study With the Empatica Embrace Watch and Smartphone-based Diary-alert System

The number of GTCS automatically detected by Embrace will be compared to the total recorded by the wearer+caregiver in a seizure diary. This fraction is the sensitivity.

The number of alerts elicited by Embrace+Alert app that do NOT correspond to convulsive seizures marked in the seizure diary are "false alarms". False alarms can also be explicitly marked by patients.

The System Usability Scale will be given to assess system usability

Empatica, Inc.

Motor Seizures

Study of Algorithm for Epilepsy Alert Device

Epilepsy Alert Device - Epilert Performance

Prof. Uri Kramer. Chief scientist

Biolert

Seizures

Sleep

Emfit Movement Monitor

LeBonheur Children's Medical Center

Pediatric Seizure Movement Bed Alarm

Pediatric Seizure Alarm: A Pilot Study to Establish Efficacy Parameters

Measure the occurrence rate of false alarms. Determine if setting parameters for detection can be established according to age and body weight of child/adult.

Determine which seizure types are best detected using the bed alarm system i.e. generalized tonic-clonic, tonic, focal clonic, complex-partial, seizure events.

James W. Wheless

Principal Investigator

Le Bonheur Children's Hospital

Participants will be dosed to a 0.08g% blood alcohol concentration.

Participants will receive a low dose of alcohol (placebo condition).

Bipolar Disorder

Alcohol Drinking

Alcohol Use Disorder

Participants will be provided alcohol during study visits and changes in behavior/neural activity after consuming alcohol will be examined.

alcohol beverage

Placebo beverage

University of Texas at Austin

Acute Alcohol Response In Bipolar Disorder: a fMRI Study

Subjective Response to Alcohol and Associated Neural Systems in Bipolar Disorder

Neural responses to emotional stimuli during the alcohol and placebo sessions will be modeled. Change in neural responses (alcohol minus placebo session) in regions of interest will be calculated. Study participation to collect data (baseline clinical assessment, alcohol and placebo MRI sessions) should not take more than 1 week.

Participants will fill out self-report surveys on how they feel when they arrive to their beverage administration sessions (alcohol and placebo). They will then feel out the same self-report surveys on how intoxicated they feel during their beverage sessions (alcohol and placebo). Changes in how intoxicated they feel will be calculated for both the alcohol and placebo condition.

Participants will complete self-report surveys describing their drinking pattern and a structured assessment (time line follow back) to assess recent quantity, duration, and frequency of drinking. Correlations between this secondary measure and primary measures listed above will be explored.

After study completion and publication of finding, functional neuroimaging data and behavior data collected following alcohol and placebo conditions will be shared.

false/tónico

Embrace: Seizure Characterization

Study of Algorithm for Epilepsy Alert Device

Pediatric Seizure Movement Bed Alarm

Acute Alcohol Response In Bipolar Disorder: a fMRI Study

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