Implementing Artificial-intelligence Wristbands to Help in Recording Seizures

Epilepsy Clinical Trial

Official title:

Implementing Artificial-intelligence Wristbands to Help in Recording Seizures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04505852
• Other study ID #: CF19347A
• Status: Recruiting
• Phase: N/A
• Start date: March 5, 2020
• Est. completion date: December 2023

Study information

• Verified date: April 2022
• Source: Taichung Veterans General Hospital
• Contact: PEIYUAN F. HSIEH, MD
• Phone: 886-4-23592525
• Email: pfhsieh[@]vghtc.gov.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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. .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Epilepsy
• Seizures

Intervention

Device:
• Embrace
Patients wear Embrace2 to help in seizure reporting and patient care.

Locations

Country	Name	City	State
Taiwan	Taichung Veterans General Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Taichung Veterans General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Satisfaction score of seizure wristband	Scores 1(least satisfied) to 10 (most satisfied)	Through study completion, an average of 1 year