Epilepsy
Conditions
Interventions
None listed
Sponsors
Epilepsiecentrum Kempenhaeghe
Eligibility
Age
2 Years to 99 Years
Inclusion criteria
Inclusion criteria: Subjects who meet all of the following criteria are eligible for this trial: 1. Between 2 and 18 years of age with or without mental impairment, or between 18 - 65 years with a mental impairment. 2. Major motor seizures defined as tonic-clonic, generalized tonic, hypermotor or series of myoclonic seizures. 3. Minimal nocturnal seizure frequency: 1/month. 4. The mentally impaired patients all live in the long-term facilities at Kempenhaeghe or SEIN. Children may live in their family home. 5. Informed consent form signed by legal representatives.
Exclusion criteria
Exclusion criteria: Subjects meeting one or more of the following criteria cannot be selected: 1. Intensive non-epileptic movement patterns such as severe choreatiform movements due to birth defects, intensive sleep walking, frequent night terrors (> 1/night) 2. Only minor motor seizures: non-generalised or short (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The combined analysis of heart rate and accelerometry, the added value of video/audio analysis and the technical performance are primary endpoints. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end points are the performances of heart rate, accelerometry, video and audio alone, comparison with the Emfit bed sensor, quality of life, optimalisation of care and levels of trust of caregivers in system performance. | — |
Countries
Netherlands
Outcome results
None listed