Cortical Excitability in West Syndrome Using Transcranial Magnetic Stimulation

NCT06201897 | Recruiting Phase 2 DMC

• 1 other identifier: IECPG156/24.03.2022-OT-12.2023
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

West Syndrome

Outcome Measures

Primary Outcomes (1)

• Change in Cortical Excitability

  Change in cortical excitability in terms of Transcranial magnetic stimulation parameters like Resting Motor Threshold, Long Interval Cortical Inhibition, Short Interval Cortical Inhibition

  12 weeks

Study Arms (1)

Treatment Arm

OTHER

Children receiving ACTH therapy for West Syndrome

Drug: ACTH/Oral Steroids

Interventions

ACTH/Oral Steroids DRUG

Injection ACTH or Oral Steroids in children with West Syndrome

Also known as: Hormonal Therapy

Treatment Arm

Eligibility Criteria

• Age: 6 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Study Sites (1)

All India Institute of Medical Sciences

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

RECRUITING

MeSH Terms

Conditions

Spasms, Infantile

Condition Hierarchy (Ancestors)

Epilepsy, Generalized; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes

Study Officials

• SHEFFALI GULATI

  All India Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheffali Gulati

CONTACT

9810386847; sheffaligulati@gmail.com

S GULATI

CONTACT

sheffaligulati1@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR

Study Record Dates

• First Submitted: January 1, 2024
• First Posted: January 11, 2024
• Study Start: March 1, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 4, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)