Clinical Trial: Longitudinal Early Epilepsy Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

Official Title: Longitudinal Early Epilepsy Study

Brief 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 Summary:

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.


Sponsor: Maastricht University Medical Center

Current Primary Outcome:

  • Change of multimodal MRI parameters on brain connectivity [ Time Frame: Baseline; first year; second year ]
  • Change of cognition measured by a battery of neuropsychological tests [ Time Frame: Baseline; first year; second year ]
  • Time in months since start of medication till seizure control is attained, as assessed by anamnesis and a confirmatory routine-EEG. [ Time Frame: Within 2 years ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Age in months at which seizures began (age of onset) assessed by interview at the baseline measurment [ Time Frame: Baseline ]
  • Seizure semiology assessed by anamnesis and video-EEG [ Time Frame: Baseline; first year; second year ]
    Seizure semiology will be re-assessed at the different time points
  • Epileptiform activity assessed by a 24h-EEG [ Time Frame: Baseline; first year; second year ]
    Epileptiform acitivty will be re-assessed at the different time points


Original Secondary Outcome: Same as current

Information By: Maastricht University Medical Center

Dates:
Date Received: September 26, 2016
Date Started: September 2016
Date Completion:
Last Updated: November 2, 2016
Last Verified: July 2016