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Implementing Artificial-intelligence Wristbands to Help in Recording Seizures

Implementing Artificial-intelligence Wristbands to Help in Recording Seizures

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04505852
Enrollment
30
Registered
2020-08-10
Start date
2020-03-05
Completion date
2023-12-31
Last updated
2022-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Brief summary

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

Interventions

DEVICEEmbrace

Patients wear Embrace2 to help in seizure reporting and patient care.

Sponsors

Taichung Veterans General Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Satisfaction score of seizure wristbandThrough study completion, an average of 1 yearScores 1(least satisfied) to 10 (most satisfied)

Countries

Taiwan

Contacts

Primary ContactPEIYUAN F. HSIEH, MD
pfhsieh@vghtc.gov.tw886-4-23592525

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026