Status:
RECRUITING
Cortical Excitability in West Syndrome Using Transcranial Magnetic Stimulation
Lead Sponsor:
All India Institute of Medical Sciences
Conditions:
West Syndrome
Eligibility:
All Genders
6-24 years
Phase:
PHASE2
PHASE3
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. Studyin...
Detailed Description
PATIENT ENROLLMENT AND MANAGEMENT: * Consecutive children with West Syndrome (clinical spasm with EEG correlate) will be screened in the study centre for eligibility, and after applying inclusion and...
Eligibility Criteria
Inclusion
- • 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
- 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.
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06201897
Start Date
March 1 2024
End Date
June 1 2026
Last Update
March 4 2024
Active Locations (1)
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1
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India, 110029