Combining factors will enable prediction of successful long-term video-EEG monitoring and of adverse effects, related to antiepileptic drug withdrawal.
ID
Bron
Verkorte titel
Aandoening
Epilepsy, epilepsy surgery
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Predictors of efficacy: A sufficient number of habitual seizures have been recorded. <br>
Predictors of safety: presence of complications, defined as any of the following: status epilepticus (defined as a seizure lasting ¡Ý 5 minutes), seizure clustering (¡Ý 3 seizures in 4 hours), falls and physical injuries, postictal psychosis, generalized tonic-clonic seizures in patients without prior occurrence of these, cardio-respiratory distress, or acute medical complications requiring intervention
Achtergrond van het onderzoek
Rationale: In people with refractory epilepsy, long-term video-EEG monitoring (LTM) is a valuable tool to evaluate eligibility for epilepsy surgery. For many patients, anti-epileptic drugs (AEDs) are tapered during LTM, but safety concerns have been raised. AED withdrawal might be related to increased complications among which status epilepticus, whilst efficacy has not been established.
Objective: to study the safety and efficacy of AED withdrawal in LTM.
Study design: prospective observational multi-centre study
Study population: children and adults undergoing LTM in the evaluation for epilepsy surgery.
Main study parameters/endpoints: the efficacy endpoint is reached when a sufficient number of habitual seizures have been recorded. Safety is defined by the presence of complications, with any of the following items: status epilepticus (defined as a seizure lasting ¡Ý 5 minutes), seizure clustering (¡Ý 3 seizures in 4 hours), falls and physical injuries, postictal psychosis, generalized tonic-clonic seizures in patients without prior occurrence of these, cardio-respiratory distress, or acute medical complications requiring intervention.
Doel van het onderzoek
Combining factors will enable prediction of successful long-term video-EEG monitoring and of adverse effects, related to antiepileptic drug withdrawal.
Onderzoeksopzet
Baseline, during LTM and four weeks after
Onderzoeksproduct en/of interventie
Not applicable
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Long-term video-EEG monitoring (LTM) is initiated in the evaluation for epilepsy surgery (all ages)
- Informed consent signed. In case of age below 16, both parents sign informed consent. For the ages 12-15 (by Dutch law, may be different per country), the child and both parents sign. If they do not, the patient will not participate.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- intracranial long-term monitoring (subdural grid or depth/stereo-EEG)
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL6445 |
NTR-old | NTR6623 |
Ander register | METC UMC Utrecht : METC 17-157/C |