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Development and validation of an algorithm for an ultra low-power miniaturized device with accelerometry, electrocardiography and electromyography based tonic seizure detection.

Development and validation of an algorithm for an ultra low-power miniaturized device with accelerometry, electrocardiography and electromyography based tonic seizure detection. - EpiSense trial

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON47184
Enrollment
30
Registered
2018-04-10
Start date
2017-04-18
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Epilepsy

Interventions

Electrocardiography
Electromyography
Epilepsy
Seizure detection
Tonic seizures
Video analysis

Sponsors

Epilepsiecentrum Kempenhaeghe
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Patients who meet all of the following criteria are eligible for this study: - Currently residing at Providentia (long stay facilities of Kempenhaeghe) - Over 18 years of age - Nightly tonic and/or tonic-clonic seizures - Minimal seizure frequency: 1/week - Informed consent form signed by legal representatives

Exclusion criteria

Exclusion criteria: Subjects meeting one or more of the following criteria cannot be selected: - History of heart failure, significant heart disease or, obstructive sleep apnea - Drugs or pacemakers that significantly influence heart rate (for example beta-blockers) - Inability to comply with the test procedure - Inability to tolerate the used electrodes

Design outcomes

Primary

MeasureTime frame
The primary study parameter is the added value of electromyography analysis to the analysis of heartrate and accelerometry.

Secondary

MeasureTime frame
Secondary study parameters are analysis of heartrate and accelerometry, comparison to the Emfit bed sensor and quality of life.

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)