To investigate the effect of early antiepileptic drugs (AEDs) withdrawal over late antiepileptic drugs (AEDs) withdrawal after pediatric epilepsy surgery
- Conditions
- Health Condition 1: null- AEDs withdrawal after pediatric epilepsy surgery
- Registration Number
- CTRI/2013/11/004122
- Lead Sponsor
- All India Institute of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 180
1. All patients who underwent for pediatric epilepsy surgery.
2. Age less than and equal to 18 years.
3. Both the physician, parents And patients, if capable will agree with randomization for participation.
4. Postoperative seizure freedom achieved.
5. Agree to follow-up.
1) Age greater than 18 years.
2) The treating physician/patient will not agree to discontinue all AEDs within given time frame.
3) Disagree to tapering of AEDs.
4) EEG abnormal except in persons who have undergone hemispherotomy.
5) All Patients who will not give consent for participation and not agree for follow-up.
6) All patients whose treating physician or parents decided to taper their drug treatment despite continuing postoperative seizures, including auras.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome will be measured for seizure recurrence and seizure outcome during or after AEDs withdrawal by ILAE (International League Against Epilepsy)/ Engel scale in both groups and compare the neuropsychological measures between the two withdrawal group at preoperatively (p1), post-operatively (p2) 12 months and 18 months (p3)Timepoint: 6 monthly follow-up and up-to 60 months
- Secondary Outcome Measures
Name Time Method Secondary outcome will be measure the quality of life, behavior and cognition during and after AEDs withdrawal which affect the seizure outcome.Timepoint: 6 monthly follow-up upto 60 months