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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.

Efficacy and tolerability of Ketogenic diet as an add on therapy in children with Electrical Status Epilepticus during Sleep

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/07/043923
Enrollment
33
Registered
2022-07-12
Start date
Unknown
Completion date
Unknown
Last updated
2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G998- Other specified disorders of nervous system in diseases classified elsewhere

Interventions

Intervention1: Ketogenic Diet: Ketogenic Diet will be administered to children fulfilling the inclusion criteria who have failed atleast two antiseizure medications and steroids Intervention2: Ketogen

Sponsors

PGIMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children aged 2-16 years of either sex with ESES refractory to at least two antiseizure medications and corticosteroids.

Exclusion criteria

Exclusion criteria: 1. Any child with EEG not consistent with ESES ( 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

Design outcomes

Primary

MeasureTime frame
1.Percentage change in SWI in EEG at 12 weeks of KD Timepoint: 12 weeks

Secondary

MeasureTime frame
1. Percentage reduction in Seizure burden at 4, 12 and 24 weeks of KD 2. Percentage change in SWI in EEG at 24 weeks of KD 3. Improvement in Cognition , Behaviour and Language at 24 weeks of KD. Timepoint: 24 weeks

Countries

India

Contacts

Public ContactDr Arushi Saini

Advanced Pediatrics Centre , PGIMER , Chandigarh

shagunsingh2792@gmail.com8146618165

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026