Evaluating dietary intervention before surgical treatment for epilepsy
- Conditions
- Subtopic: All DiagnosesTopic: ChildrenDisease: All DiseasesNervous System Diseases
- Registration Number
- ISRCTN41638605
- Lead Sponsor
- niversity College London (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped
- Sex
- All
- Target Recruitment
- 60
Current as of 19/09/2017:
This is applicable to all participating countries with trial approvals working to Protocol V5.0 06/09/2016 except Austria and Germany (working to Protocol V2.0 17/03/2015)
1. Children aged 3 - 15 years;
2. MRI changes consistent with a diagnosis of FCD type II a or b;
3. History of at least two epileptic seizures in the past 6 months before randomisation;
4. Seizure semiology consistent with focal onset, agreed after pre-surgical discussion to be surgically treatable;
5. Parent/ legal representative willing to give consent.
Previous inclusion criteria:
1. Children aged 5-15 years
2. MRI changes consistent with a diagnosis of Focal Cortical Dysplasia type II a or b
3. History of continuing seizures for less than 5 years
4. History of at least two epileptic seizures in the past 6 months before randomisation
5. Seizure semiology consistent with focal onset, agreed after pre-surgical discussion to be surgically treatable
6. Failure of at least two antiepileptic drugs to control the seizures
7. Parent/legal representative willing to give consent
1. Previous use of the ketogenic diet
2. Not a surgical candidate for Focal Cortical Dysplasia resection
3. Administration of the ketogenic diet is medically contraindicated
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to 6 month remission; the time to 6 months of seizure freedom from the date of randomisation
- Secondary Outcome Measures
Name Time Method