Topic: Children
Conditions
Interventions
Children will be randomised to either receive 6m treatment presurgery with a ketogenic diet, or to proceed direct to surgery (no pretreatment).
Sponsors
University College London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to 6 month remission; the time to 6 months of seizure freedom from the date of randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Current as of 19/09/2017: 1. Time to first seizure from date of randomisation; 2. Time to 12 month remission after randomisation; 3. Time to 24 month remission after randomisation (if enough time for follow-up is available); 4. Quality of life at 12 months after randomisation (and at 24 months if enough time for follow-up is available); 5. Adaptive behaviour assessment at 12 months (() after randomisation (and at 24 months if enough time for follow-up is available); 6. Methylation changes in tissue (DNA) from children pre-treated with the ketogenic diet. Tissue will be stored in the EEBB, and further distributed to DESIRE partners (Baker IDI Heart and Diabetes Institute Holdings Ltd, Varionostic GMBH,CEGAT) for further analysis; 7. Changes in peripheral DNA (blood platelets) following treatment with the KD. Tissue will be stored in the EEBB, and further distributed to DESIRE partners (Baker IDI Heart and Diabetes Institute Holdings Ltd, Varionostic GMBH,CEGAT) for further analysis; 8. Proportion of immediate AEs following resective surgery (i.e. surgical complications within 30 days) in the group pre-treated with KD compared to those without. 9. Compare the general AE occurrence between the group pre-treated with KD compared to the group without KD pre-treatment. Previous secondary outcome meaures: 1. Methylation changes in tissue (DNA); Timepoint(s): At the time of surgery between ketogenic diet pre-treatment group vs non pre-treated group 2. Neuropsychological assessment; Timepoint(s): Neuropsychological assessment at 12 and at 24 months after randomisation 3. Peripheral DNA changes (blood); Timepoint(s): At baseline and at the time of surgery 4. Proportion of immediate AEs following resective surgery; Timepoint(s): Surgical complications with | — |
Countries
Austria, Czech Republic, France, Germany, Italy, Switzerland, United Kingdom, United States of America
Outcome results
None listed