The Modified Ketogenic Diet for the Treatment of Pharmacoresistant Epilepsy in Adults
- Conditions
- Epilepsy
- Registration Number
- NCT03425110
- Brief Summary
The Modified Ketogenic Diet for the Treatment of Pharmacoresistant Epilepsy in Adults: an Observational Cohort Study
- Detailed Description
Epilepsy is a common neurological condition. Unfortunately, just over 30% of patients with epilepsy (PWE) do not become seizure free with anti-epileptic drugs. Some patients may be suitable for epilepsy surgery. Alternative established treatments include vagal nerve stimulation and the ketogenic diet in children. The evidence base for the use of ketogenic diet in adults is limited. There are a few prospective studies and no randomised control trial to date.
This study is a prospective observational cohort study for adult patients with drug resistant epilepsy who are not suitable for resective epilepsy surgery. The intervention is a modified ketogenic diet. The carbohydrate load will be between 20-30gm per day. Blood ketones and blood sugars will be monitored. The primary outcome measure is seizure frequency at 12 months. There are a number of secondary outcome measures including tolerability, seizure severity, quality of life, lipid profiles and health care utilisation.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 50% responder rate Twelve months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Complex Epilepsy Service, The Barberry, BSMHFT
🇬🇧Birmingham, West Midlands, United Kingdom
Complex Epilepsy Service, The Barberry, BSMHFT🇬🇧Birmingham, West Midlands, United KingdomMKD ServiceContact0121 301 2426bsmhft.modifiedketogenicdiet@nhs.net