Health Condition 1: G400- Localization-related (focal) (partial) idiopathic epilepsy and epileptic syndromes with seizures of localized onset
Conditions
Interventions
Intervention1: Repetitive low frequency (0.5 Hz) transcranial magnetic stimulation: Two cycles of rTMS therapy (1st Cycle:10 days (week
1 and 2) and 2nd cycle: 5days (week 11) targeted at the seizure
Sponsors
ICMRIndia
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children with more than or equal to 1 seizure per week OR 4 seizures per month despite on more than or equal to 2 appropriately chosen and optimally prescribed antiseizure drugs. 2. Duration of epilepsy for atleast 1 year 3. Seizures of single semiology 4. Majority (75%) of Interictal epileptiform discharges (SWI) arising over a single epileptogenic focus on sleep EEG 5. Parents or guardians willing to follow the treatment protocol being followed in the study. 6.Parents/guardians do not want to undergo epilepsy surgery. 7. Child is not eligible for epilepsy surgery or Parents/ guardians are un willing to undergo epilepsy surgery.
Exclusion criteria
Exclusion criteria: 1. Hemispheric epilepsy syndromes such as Rasmeussen’s encephalitis, Hemiconvulsion- hemiplegia epilepsy syndrome or Hemimegalancephaly. 2. Diagnosed epileptic encephalopathy other than focal ESES (Electrical status epilepticus in sleep as per standard definition) 3. Diagnosed progressive neurological disorder 4. Previous epilepsy surgery or vagal nerve stimulation insertion. 5. Presence of Metallic implants anywhere in the body. 6. Epilepsy surgery planned within nine months from the date of enrollment. Secondary Exclusion Criteria (To be applied after 4-week observation period) 1. Less than 4 seizure/ month 2. Improperly filled seizure log 3. Change in antiseizure drug therapy (except for use of benzodiazepine as abortive medication) 4. More than one epileptogenic focus on EEG 5. Status epilepticus 6. Lack of consensus on epileptogenic zone
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the proportion of children and adolescents between 5-18 years, with drug resistant focal epilepsy, who achieve 50% seizure reduction at week 15 of study period, compared to baseline, in both active and sham rTMS therapy groups.Timepoint: The primary outcome would be analyzed at 15 weeks from baseline (from the time of randomisation) | — |
Secondary
| Measure | Time frame |
|---|---|
| To analyze the change in social quotient (measured by Vineland social maturity scale) and behavior (Childhood behavior checklist) with rTMS therapy from baseline to 30 weeks of therapy in children and adolescents between 5-18 years with drug resistant focal epilepsy.Timepoint: Baseline and 30 weeks;To determine the proportion of children between 5-18 years, with drug resistant focal epilepsy, who achieve 50% seizure reduction at week 30 of rTMS therapy, compared to baseline.Timepoint: 30 weeks;To study the concordance between change in cortical excitability as measured by TMS parameters (MT, SICI and LICI) and seizure reduction, cognition and behavior in children between 5-18 years, with drug resistant focal epilepsy at multiple time points during the study period.Timepoint: multiple time points;To study the immediate (within 24 hr), short term (week 15) and long term (week 30) side effect profile of rTMS in children and adolescents between 5-18 years, with drug resistant focal epilepsy.Timepoint: 24 hours,15 weeks and 30 weeks;To study the time required to achieve complete seizure cessation with rTMS therapy in children 5-18 years with drug resistant focal epilepsy.Timepoint: complete seizure cessation | — |
Countries
India
Contacts
Public ContactDr Prashant Jauhari
AIIMS New Delhi
Outcome results
None listed