Actively Recruiting

Phase 2
Phase 3
Age: 6Months - 24Months
All Genders
NCT06201897

Cortical Excitability in West Syndrome Using Transcranial Magnetic Stimulation

Led by All India Institute of Medical Sciences · Updated on 2024-03-04

40

Participants Needed

1

Research Sites

117 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Cortical Excitability in West Syndrome Using Transcranial Magnetic Stimulation

Who Can Participate

Age: 6Months - 24Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 6 months to 2 years with confirmed electroclinical diagnosis of West Syndrome
  • Sleep EEG performed within 1 week before screening
  • Negative tuberculosis screening (Chest X-ray PA view and Mantoux test)
  • Parents willing for ACTH or ketogenic diet therapy
Not Eligible

You will not qualify if you...

  • Already on ACTH, prednisolone, vigabatrin, or ketogenic diet therapy for more than 5 days
  • Diagnosis of tuberous sclerosis
  • Responsiveness to vitamin trial
  • Known contraindications for ketogenic diet (e.g., inborn errors of metabolism, porphyria)
  • Chronic systemic illnesses such as chronic kidney disease or congenital heart diseases
  • Parents refusing consent for study participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, India, 110029

Actively Recruiting

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Research Team

S

Sheffali Gulati

CONTACT

S

S GULATI

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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