Seizures
Conditions
Brief summary
There are no guidelines or studies evaluating duration of anti-epileptic drugs in central nervous system infections. The duration of anti-epileptic drug is extrapolated from traumatic brain injury in which duration of 1 weeks to 3 months is suggested. So the investigators plan to conduct this study to decide the optimal duration of anti-epileptic drug in acute symptomatic seizure in central nervous system infections
Detailed description
Demography data, seizure details at diagnosis of acute encephalitis syndrome, details of etiology, neuroimaging findings and electroencephalography. A detailed neurological examination will be done in all participants and asked for seizure semiology at admission. Seizure details include seizure type, duration, number of seizures, number of days for which seizures were recurring, status epilepticus, encephalopathy in between seizures. After the initial assessment participants would be randomized into 2 groups: Group 1: Anti-epileptic drug for 4 weeks followed by taper in 10-14days and Group 2: Anti-epileptic drug for 12 weeks followed by tapering over 10-14days. The primary outcome would be be to study the seizure relapse rate (proportion) after stopping anti-epileptic drugs in participants with acute symptomatic seizure given 4weeks and 12 weeks anti-epileptic drug therapy in the two study groups. Clinical status will be assessed at enrollment as defined by Pediatric Cerebral Performance Category, Pediatric overall Performance Category and Glasgow Outcome Scale-Extended Pediatric Version (GOS-P)
Interventions
OTHERGroup 4 weeks
Anti-epileptic drug (as used by treating physician for management of acute symptomatic seizure) for 4 weeks followed by taper in 10-14days
OTHERGroup 12 weeks
Anti-epileptic drug (as used by treating physician for management of acute symptomatic seizure) for 12 weeks followed by taper in 10-14days
Sponsors
Post Graduate Institute of Medical Education and Research, Chandigarh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open label study
Intervention model description
Whether 4 weeks anti-epileptic drug is as efficacious as 12 weeks anti-epileptic drug therapy for Acute Encephalitis syndrome
Eligibility
Sex/Gender
ALL
Age
3 Months to 12 Years
Healthy volunteers
No
Inclusion criteria
* Children with acute encephalitis syndrome with acute symptomatic seizures on single anti-epileptic drug will be enrolled in Out patient clinic at 4 weeks of illness
Exclusion criteria
* Children with chronic meningitis, brain abscess, intracranial Space occupying lesion * Children with prior history of seizures, prior focal neurological deficit * Children with abnormal development prior to development of seizures * HIV, Chronic Liver disease, Chronic Kidney disease, acute hepatic encephalopathy * Children on two or more than 2 anti-epileptic drugs * Severely affected children (Pediatric Cerebral Performance Category Scale (PCPC) Score, Pediatric Overall Performance Category Scale with category score of 5) * Refusal of consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seizure relapse rate | 6 months | Seizure relapse rate (proportion of participants) developing seizures after randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of EEG findings at time of stoppage of anti-epileptic drug with seizure recurrence | 6 months | Correlation of EEG at randomization and seizure recurrence will be done |
| Factors associated with seizure recurrence | 6 months | Factors associated with seizure recurrence in the two groups |
| Seizure relapse rate | 12 months | Seizure relapse rate (proportion of participants) developing seizures after randomization |
Outcome results
None listed