Actively Recruiting

Phase 2
Phase 3
Age: 6Months - 24Months
All Genders
ID06201897

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

Age: 6Months - 24Months
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Follow-up

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

Loading map...

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

Similar Trials

A Multicenter Pilot Clinical Trial to Prevent Infantile Spas...

Infantile Spasms

Actively Recruiting

1 location

Efficacy of Vigabatrin With High Dose Prednisolone Combinati...

Infantile Spasm

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here