Efficacy and tolerability of Ketogenic Diet in Children with Electrical Status in Sleep in terms of reduction of seizure burden , improvement in cognition , language and behaviour.
- Conditions
- Health Condition 1: G998- Other specified disorders of nervous system in diseases classified elsewhere
- Registration Number
- CTRI/2022/07/043923
- Lead Sponsor
- PGIMER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 22
1.Children aged 2-16 years of either sex with ESES refractory to at least two antiseizure medications and corticosteroids.
1.Any child with EEG not consistent with ESES ( <50% SWI in slow wave sleep )
2.Children with ESES >50% SWI in slow wave sleep who become seizure-free with 2 antiseizure medications and corticosteroids
3.Children with ESES >50% SWI in slow wave sleep who take KD for less than one-week duration
4.Decline of consent by parent/guardian
5.Children with active or past history of hyperlipidemia and /or renal calculi, pancreatitis, liver failure, suspected or proven disorders of fat metabolism, primary carnitine deficiency, carnitine palmitoyl transferase deficiency, carnitine translocase deficiency, porphyrias, or pyruvate kinase deficiency
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method