Implementing Artificial-intelligence Wristbands to Help in Recording Seizures

The investigators hypothesize that the participants will be satisfied with artificial-intelligence wristband Embrace

Study Overview

• Status: Recruiting
• Conditions: Epilepsy
• Intervention / Treatment: Device: Embrace

Detailed Description

Currently, seizure tracking relies on subjective patient and family recall. In several studies patients report only approximately half of their seizures, and even less during sleep.

Sudden unexplained death in epilepsy (SUDEP) is the cause of premature death of up to 17% of all patients with epilepsy and as many as 50% with chronic refractory epilepsy (with rates as high as 1% per year). Its etiology is probably due to peri-ictal respiratory, cardiac, or autonomic nervous system dysfunction.

Wristband sensors help caregivers assist patients during seizures and may reduce risks for complications such as injuries and SUDEP.

Accurate seizure detection may improve the quality of life (QoL) of subjects and caregivers by decreasing burden of seizure monitoring and may facilitate diagnostic monitoring in the home setting. Possible risks are occurrence of alarm fatigue and invasion of privacy.

The wristband Embrace has an overall sensitivity of 89.1% and an overall specificity of 93.1%. The investigators hypothesize that the participants will be satisfied with artificial-intelligence wristband Embrace.

Methods:

When the smart wristband detects the seizure, the mobile phone sends a text message to the companion and the nurse, the latter will see or get in touch with the companion and keep a record.

In-patients receiving video-electroencephalography (VEEG) exam use Embrace during the VEEG recording which usually takes 3-5 days.

Out-patients use Embrace for 8 weeks. The investigators will enroll 30-50 patients, half in-patients and half out-patients.

The benefits are evaluated in terms of satisfaction. .

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: PEIYUAN F. HSIEH, MD; Phone Number: 3021 886-4-23592525; Email: pfhsieh@vghtc.gov.tw

Study Locations

• Taiwan
  • Taichung, Taiwan, 40705
    • Recruiting
    • Taichung Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• At least one seizure per month in the 3-month period before entering the study

Exclusion Criteria:

• Uncountable seizures, psychogenic seizures, alcohol or drug abuse, severe heart or lung disorder, rapid progressive brain disorder, life-terminal disease, severe infection/ bleeding/ liver/ kidney disorder, platelet <80,000/μL, neutrophil <1,000/μL, clinically significant ECG abnormality, unstable psychiatric disease (except anxiety).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EMBRACE USERS; Embrace wristband users	Device: Embrace; Patients wear Embrace2 to help in seizure reporting and patient care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction score of seizure wristband	Scores 1(least satisfied) to 10 (most satisfied)	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Taichung Veterans General Hospital
• Investigators: Principal Investigator: PEIYUAN F. HSIEH, MD, Taichung Veterans General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2020
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: August 5, 2020
• First Submitted That Met QC Criteria: August 6, 2020
• First Posted (Actual): August 10, 2020

Study Record Updates

• Last Update Posted (Actual): April 28, 2022
• Last Update Submitted That Met QC Criteria: April 26, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Seizures
• Other Study ID Numbers: CF19347A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No