Actively Recruiting
Comparison of Pre- and Post-Therapy Cortical Excitability Using Transcranial Magnetic Stimulation in Children with West Syndrome: A Longitudinal Study
Led by All India Institute of Medical Sciences · Updated on 2024-03-04
40
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying cortical excitability in children with West Syndrome, a unique epilepsy syndrome characterized by infantile onset epilepsy and significant neurodevelopmental delay. This study aims to understand how cortical excitability relates to disease activity and whether it can predict response to ACTH therapy by measuring changes before and after treatment. The research seeks to generate new insights into seizure pathogenesis, individualized antiepileptic therapy, and treatment response in childhood epilepsy. The study involves children aged 6 months to 2 years diagnosed with West Syndrome. Participants will undergo initial evaluation, including history, clinical examination, and necessary investigations such as MRI and vitamin trials. Those eligible will receive high-dose ACTH therapy for 6 weeks, with doses tapered after 2 weeks. Children with less than 50% spasm reduction may start ketogenic diet therapy under supervision or choose other treatment options. Transcranial Magnetic Stimulation (TMS) and EEG will be performed at baseline, 6 weeks, and 3 months to assess cortical excitability and treatment effects. During the study, participants will have regular follow-ups at 6 weeks, 8 weeks, and monthly up to 6 months when feasible. Researchers will monitor seizure frequency, adverse events, treatment compliance, and neurodevelopmental assessments. Outcome measures include changes in cortical excitability at 12 weeks and spasm reduction rates. Investigations and therapies related to the study will be provided at no cost. Parents will give informed consent and can withdraw their child anytime without affecting future care.
CONDITIONS
Brief Title
Cortical Excitability in West Syndrome Using Transcranial Magnetic Stimulation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 6 months to 2 years with electroclinical diagnosis of West Syndrome
- Sleep EEG performed within 1 week before screening
- Negative tuberculosis screening (Chest X-ray and Mantoux test)
- Parents willing to consent for ACTH or ketogenic diet therapy
You will not qualify if you...
- Prior use of 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 enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants receive ACTH therapy with a high dose for 2 weeks followed by a slow taper over 4 weeks. Anti-epileptic drugs will be optimized concurrently.
Twice weekly visits for blood sugar and blood pressure monitoring; EEG and TMS assessments at baseline and 6 weeks
Duration - Up to 6 months
Participants are monitored for spasm reduction and electroclinical response with EEG and TMS assessments at 3 months. Follow-up visits continue monthly for up to 6 months where feasible.
Visits at 6 weeks, 8 weeks, then monthly for up to 6 months
Trial Site Locations
Total: 1 location
1
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India, 110029
Actively Recruiting
Research Team
S
Sheffali Gulati
S
S GULATI
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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