NCT02954107

Longitudinal Early Epilepsy Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Accepted

Summary

This longitudinal study will focus on the cognitive and brain development of children with absence epilepsy. In addition, the investigators aim to identify prognostic factors for cognitive deterioration and/or poor seizure control in these children.

Detailed description

The aim is to study the cognitive and brain development of children with absence epilepsy. In addition, this study aims to identify prognostic factors for cognitive deterioration and/or poor seizure control. Objective: 1. To study the development of cognition in children with absence epilepsy and the functional brain organization over time. 2. To find prognostic factors in terms of clinical, 24h-video-EEG or/and MRI characteristics for cognitive deterioration and/or poor seizure control in patients with absence epilepsy. Study design: 2 year prospective longitudinal, controlled, comparative, clinical, follow up. Study population: 60 children with recently diagnosed (\<2 years) absence epilepsy, aged 6 to 12 years. In addition, this study includes a control group of 15 age and gender matched healthy volunteers. Main study parameters/endpoints: Endpoints are the development of clinical parameters (semiology, 24h-video-EEG and seizure control), neuropsychological/behavioural outcomes, structural/functional MRI parameters, and educational performance.

Conditions

• Absence Epilepsy
• Epilepsy, Absence

Interventions

Type	Name	Description
OTHER	MRI
OTHER	24h-EEG + video
OTHER	Neuropsychological tests

Timeline

• Start date: 2016-09-01
• Primary completion: 2019-09-01
• Completion: 2020-01-01
• First posted: 2016-11-03
• Last updated: 2018-11-19

Locations

2 sites across 1 country: Netherlands