Keywords: Refractory Epilepsy Intellectual disability Modified Atkins Diet In Dutch: Refractaire epilepsie Verstandelijke beperking Gemodificeerde Atkins dieet
Conditions
Interventions
The intervention group will be treated with the MAD for at least 4 months, with a total follow-up of at least 6 months. After the 4-month trial period, the control group can be started on the MAD as w
Sponsors
Tergooiziekenhuizen
Eligibility
Inclusion criteria
Inclusion criteria: • Age > 18 years, moderate to severe ID; • Refractory epilepsy, defined as failure of two tolerated and appropriately chosen and used AED schedules; • More than two seizures per month, which are judged by the carers and the treating physician to impose a significant impact on the patients’ QOL –-justifying treatment; • Informed consent obtained by at least one legal representative;
Exclusion criteria
Exclusion criteria: • Undergone epilepsy surgery in the last 6 months, or awaiting presurgical evaluation; • Underwent implantation of a vagal nerve stimulation in the last 6 months; • Previous use of the MAD or the KD for more than 7 days in the last year prior to inclusion; • Hypercholesterolemia (total cholesterol >8), known cardiovascular disease or kidney failure, known metabolic disorders; • Severe underweight, defined as a BMI < 16.5; • Diabetes Mellitus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter will be the number of responders 4 months after randomization, compared between the intervention and the control group. Responder is defined by >50% reduction in seizure frequency. | — |
Secondary
| Measure | Time frame |
|---|---|
| Retention of the diet; change in daily functioning; feasibility of the MAD in this population and setting; adverse events attributable to the MAD; predictive factors of efficacy of the diet. | — |
Contacts
Public ContactH.M. Hulshof
Physician - medical researcher Department of Neurology Tergooiziekenhuizen Postbus 10016 1201 DA Hilversum The Netherlands
Outcome results
None listed