Health Condition 1: G969- Disorder of central nervous system, unspecified
Conditions
Interventions
Intervention1: Transcranial Magnetic Stimulation: rTMS
1.Frequency 0.5 Hz
2.Intensity 110% RMT
3.No of pulses/train 1200
4.No of trains 2 trains of 600 each with 3 min
gap
5.Stimulation site Epilep
Sponsors
DGAFMS
Eligibility
Inclusion criteria
Inclusion criteria: Children and adolescents of either sex aged 4 -18 years diagnosed with drug refractory epilepsy as per with ILAE 2017. Drug refractory epilepsy will be defined as � 1 seizure / week OR 4 seizures/month despite on � 2 appropriately chosen and optimally prescribed antiepileptic drugs. 1. Duration of epilepsy for atleast 1 year 2. Seizures of single semiology 3. Majority (75%) of Interictal epileptiform discharges (SWI) arising over a single epileptogenic focus on sleep EEG 4.Parents/ guardians willing to follow the treatment protocol of daily sessions for 10 days in 2 week with Sunday off and hospital follow up at 12 weeks of total study period
Exclusion criteria
Exclusion criteria: 1. Hemispheric epilepsy syndromes such as Rasmeussenââ?¬•s encephalitis, Hemiconvulsion-hemiplegia epilepsy syndrome or Hemimegalancephaly. 2.Diagnosed epileptic encephalopathy other than focal ESES (Electrical status epilepticus in sleep) 3.Diagnosed progressive neurological disorder 4. Previous epilepsy surgery or vagal nerve stimulation insertion. 5.Patient waitlisted for epilepsy surgery within 6 months 6.Presence of Metallic implants anywhere in the body.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the proportion of children and adolescents between 4-18 years, with drug resistant epilepsy, who achieve 50% seizure reduction at 12 weeks follow up compared to baseline. Timepoint: At baseline At 12 week post therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To compare mean reduction in seizure frequency from baseline with low frequency rTMS therapy at follow up period of 12 weeks in children and adolescents aged 4-18 years with focal onset drug refractory epilepsy 2. To determine the proportion of children and adolescents between 4-18 years, with drug resistant focal epilepsy, who achieve 50% reduction in spike wave index in a 30 min sleep interictal video EEG at 12 weeks follow up. 3.To study the change in cortical excitability induced by rTMS therapy in children and adolescents between 4-18 years, with drug resistant epilepsy in terms of pre and post therapy change in motor threshold (MT) using single pulse TMS and SICI and LICI using paired pulses. 4.To study the effect of rTMS on the behavioural profile (as per CBCL) and cognition (MISIC) of children and adolescents between 4-18 years with drug resistant epilepsy. 5.To evaluate the effect of rTMS therapy on Caregiver-rated Impression of Change (CIC) from baseline Timepoint: Assessment at 3 months | — |
Countries
India
Contacts
Public ContactCol Dr Rahul Sinha
Command Hospital
Outcome results
None listed