Investigating Cortical Excitability in Children with West Syndrome
Comparison of Pre- and Post- Therapy Real Time Cortical Excitability in West Syndrome Using Transcranial Magnetic Stimulation: A Longitudinal Cohort Study
This study is testing whether measuring brain activity in young children with West Syndrome can help predict how well they will respond to a specific treatment for their seizures.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 6 Months to 24 Months |
| Sex | All |
| Sponsor | All India Institute of Medical Sciences Academic / other |
| Drugs / interventions | Immunotherapy |
| Locations | 1 site (New Delhi, National Capital Territory of Delhi) |
| Trial ID | NCT06201897 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the relationship between cortical excitability and various aspects of West Syndrome in children, including seizure activity and neurobehavioral patterns. By enrolling children aged 6 months to 2 years with a confirmed diagnosis of West Syndrome, the study will assess how cortical excitability may serve as a non-invasive biomarker for predicting treatment outcomes following ACTH therapy. Participants will undergo thorough screening and clinical evaluations, including EEG and MRI, to rule out other etiologies before receiving optimized anti-epileptic drugs and potential ACTH treatment. The study seeks to provide new insights into the underlying mechanisms of childhood epilepsy and improve therapeutic strategies.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 6 months to 2 years diagnosed with West Syndrome who have not previously received certain therapies.
Not a fit: Patients with known contraindications for ketogenic diet therapy or those who have already been on ACTH or similar therapies for more than 5 days may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for children with West Syndrome, enhancing their quality of life and developmental outcomes.
How similar studies have performed: While the specific approach of correlating cortical excitability with West Syndrome outcomes is novel, similar studies in other epileptic syndromes have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New Delhi, National Capital Territory of Delhi
- All India Institute of Medical Sciences — New Delhi, National Capital Territory of Delhi, India (Recruiting)
Study contacts
- Principal investigator: Sheffali Gulati — All India Institute of Medical Sciences
- Study coordinator: Sheffali Gulati
- Email: sheffaligulati@gmail.com
- Phone: 9810386847
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.