NL-OMON47184
Completed
N/A
Development and validation of an algorithm for an ultra low-power miniaturized device with accelerometry, electrocardiography and electromyography based tonic seizure detection. - EpiSense trial
Epilepsiecentrum Kempenhaeghe0 sites30 target enrollmentTBD
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Epilepsiecentrum Kempenhaeghe
- Enrollment
- 30
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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