The objective of this study is to develop an algorithm for the detection of nightly tonic seizures. The to be developed algorithm has to be designed in a way that it can be embedded in an ultra low-powert miniaturized device.The clinical usefulness…
ID
Source
Brief title
Condition
- Seizures (incl subtypes)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is the added value of electromyography analysis to
the analysis of heartrate and accelerometry.
Secondary outcome
Secondary study parameters are analysis of heartrate and accelerometry,
comparison to the Emfit bed sensor and quality of life.
Background summary
The longstay facilities of Kempenhaeghe are home to patients with recurrent
epilepsy. A large group of these patients suffer from tonic or tonic-clonic
epileptic seizures. The tonic phase of these seizures are characterized by
severe continuous muscle contraction of all muscles in the body (therefore
there is hardly no movement), including the respiratory muscles. This may
result in loss of consciousness, and depression of respiratory activity. In
some cases, this type of seizure may even lead to SUDEP (Sudden Unexplained
Death in EPilepsy). Therefore, seizuredetection during nighttime, when
supervision is at a minumum, is of great importance for the patients and their
families/caretakers in order to provide immediate medical care if necessary.
Because of their lack of movement, tonic seizures are hard to detect using
current detection methods. The developed sensor for this study (EpiSense) is
focused on the detection of the tonic phase. The addition of
electromyography-based detection to existing techniques such as accelerometry
and electrocardiography should allow for an accurate and reliable detection of
tonic seizures.
Study objective
The objective of this study is to develop an algorithm for the detection of
nightly tonic seizures. The to be developed algorithm has to be designed in a
way that it can be embedded in an ultra low-powert miniaturized device.
The clinical usefulness (in terms of sensitivity and positive predictive value)
will be evaluated through:
- The added value of electromyography measurements in a population of adult
patients with mental impairment.
Study design
This is a non-randomized observational clinical trial in 30 adults (over the
age of 18) with mental impairment and medically intractable epilepsy. each
subject will undergo all-night monitoring during maximum 4 weeks in which the
multimodal seizure detection system will be applied in the home situation of
the patient. Expert review of the nocturnal video recordings will serve as a
gold standard.
Study burden and risks
There are no risks and there is no burden associated with participation in the
study.
Sterkselseweg 65
Heeze 5591VE
NL
Sterkselseweg 65
Heeze 5591VE
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL58655.015.16 |