NCT06201897 Cortical Excitability in West Syndrome Using Transcranial Magnetic Stimulation
| NCT ID | NCT06201897 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | All India Institute of Medical Sciences |
| Condition | West Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-03 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 40 participants in total. It began in 2024-03 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
SHEFFALI GULATI
PRINCIPAL INVESTIGATOR
All India Institute of Medical Sciences
Frequently Asked Questions
Who can join the NCT06201897 clinical trial?
This trial is open to participants of all sexes, aged 6 Months or older, up to 24 Months, studying West Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06201897 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06201897 currently recruiting?
Yes, NCT06201897 is actively recruiting participants. Contact the research team at sheffaligulati@gmail.com for enrollment information.
Where is the NCT06201897 trial being conducted?
This trial is being conducted at New Delhi, India.
Who is sponsoring the NCT06201897 clinical trial?
NCT06201897 is sponsored by All India Institute of Medical Sciences. The principal investigator is SHEFFALI GULATI at All India Institute of Medical Sciences. The trial plans to enroll 40 participants.