Study of effect of treatment versus no treatment on seizures, psychological, behavioral and EEG parameters in children with BECTS type of epilepsy

Suspended

• Conditions: Children suffering from Benign Epilepsy with centro-temporal spikes ( BECTS)

• Registration Number: CTRI/2018/02/012248
• Lead Sponsor: Bharati Vidyapeeth Medical College Pune

Brief Summary

After screening for eligibility, patients will be randomized to treatment or No treatment group. At baseline, both groups will undergo EEG, neuro-psychological and language testing. These tests will be repeated at the end of 1 and 2 years on follow up. In the treatment group, Valproate will be started, follow up will be done 3 monthly, including for monitoring for any side effects . In no treatment group, follow up will be done 3 monthly. The difference in these parameters in both the groups will be studied at the end of 2 years

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-04
• Last Update Posted: 2023-09-18

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Onset of seizures after the age of 3 years 2.
• History of at least one typical seizure 3.
• Normal neurological and development history 4.Clinical and EEG criteria suggestive of BECTS according to ILAE criteria 5.
• No other seizure type.

Exclusion Criteria

• Prior neurological deficits 2.
• Pre-existing psychiatric conditions 3.
• Symptomatic etiology 4.
• 3 or more seizures in last 3 months 5.
• Already on anti-epileptics for more than a week.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the changes in cognition ( IQ), language, behavior and academic achievement of children with newly diagnosed BECTS, between the no treatment group versus the Treatment group; from baseline to follow up over 2 years.	3 monthly till 2 years

Secondary Outcome Measures

Name	Time	Method
i) To study the clinical and the EEG profile in these children at baseline and further till 2 years	ii) To compare the seizure recurrence rates between the two groups

Trial Locations

Locations (2)

Bharati Vidyapeeth University Medical College Pune; 🇮🇳 Pune, MAHARASHTRA, India

Jaslok Hospital, Mumbai; 🇮🇳 Mumbai, MAHARASHTRA, India

Bharati Vidyapeeth University Medical College Pune

🇮🇳Pune, MAHARASHTRA, India

Dr Kavita Srivastava

Principal investigator

9850825791

kavisri1970@gmail.com