Comparison of Pre- and Post- Therapy Real Time Cortical Excitability in West Syndrome Using Transcranial Magnetic Stimulation: A Longitudinal Cohort Study

IECPG156/24.03.2022-OT-12.2023

Currently, no literature is available regarding degree of cortical excitability and its correlation with various epileptic syndromes and disorders such as West Syndrome in pediatric age group. Studying the complex interaction of cortical excitability, seizures, neurobehavioral patterns and brain maturation in children may provide valuable information and new insights about the underlying neuropathogenic pathways in childhood epilepsy. West Syndrome is a unique epilepsy syndrome amalgamating infantile onset epilepsy with significant neurodevelopmental delay. Due to this reason, it is the ideal disorder to study this complex interaction. How cortical excitability correlates with disease activity in West Syndrome is speculative. The ability of disease characteristics such as degree of cortical excitability to predict successful outcome after ACTH therapy (non-invasive biomarker of treatment response) in children with West Syndrome has not been explored. Most importantly, the present study may be a hypothesis generating initial step bringing new insights into neurocognitive effects of seizures, seizure pathogenesis, individualized antiepileptic drug therapy and for studying treatment response. The investigators aim to determine the change in cortical excitability pre and post ACTH therapy, in children with West syndrome and whether the change predicts responsiveness to ACTH therapy, in terms of reduction in spasm frequency at 12 weeks.

2024-03-01

2026-05-01

2026-06-01

Recruiting

Early phase I

40

Inclusion Criteria: * • Children, aged 6 months - 2 years with electroclinical diagnosis of West syndrome * Sleep EEG available within last 1 week before screening. * Screen for tuberculosis (Chest X-ray PA view and Mantoux testing) negative * Parents willing for ACTH or Ketogenic Diet therapy Exclusion Criteria: * Already on ACTH, prednisolone vigabatrin or KD therapy \> 5days * Tuberous sclerosis * Vitamin trial responsiveness * Known Pre-existing contraindications for KD (IEM, Porphyria etc.) * Chronic systemic illness (Ex: Chronic kidney disease, congenital heart diseases etc) * Parents refusing consent for enrolment in the study.

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2024-03-04