Reducing antiepileptic medication during a multiple-day video-EEG to investigate the feasibility of epilepsy surgery: what is the best way (safest and most efficious) to reduce antiepileptic drugs?

The NeedToStop study. Antiepileptic drug withdrawal in long-term video-EEG monitoring for pre-surgical evaluation: a European safety and efficacy analysis

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON22478

Enrollment

850

Registered

2017-07-20

Start date

2017-04-10

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, epilepsy surgery

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: - 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.

Exclusion criteria

Exclusion criteria: - intracranial long-term monitoring (subdural grid or depth/stereo-EEG)

Design outcomes

Primary

Measure	Time frame
Predictors of efficacy: A sufficient number of habitual seizures have been recorded. 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	—

Measure

Time frame

Predictors of efficacy: A sufficient number of habitual seizures have been recorded. 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

—

Secondary

Measure	Time frame
- The proportion of patients with AED tapering. - Baseline differences between patients with and patients without AED tapering - Efficacy comparison between patients with and patients without AED tapering - Safety comparison between patients with and patients without AED tapering - Effects of AED withdrawal and restart of AEDs on seizure frequency and cognitive and emotional functioning in the weeks after LTM	—

Measure

Time frame

- The proportion of patients with AED tapering. - Baseline differences between patients with and patients without AED tapering - Efficacy comparison between patients with and patients without AED tapering - Safety comparison between patients with and patients without AED tapering - Effects of AED withdrawal and restart of AEDs on seizure frequency and cognitive and emotional functioning in the weeks after LTM

—

Contacts

Public ContactHJ Lamberink

h.j.lamberink@umcutrecht.nl

Outcome results