Health Condition 1: G402- Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with complex partial seizures
Conditions
Interventions
Intervention1: continuous theta burst stimulation: Frequency 3 pulses at 50 Hz- 1 BURST /
Intensity at 80 percent of RMT of Abductor Policis Brevis /
Interburst interval of 200ms (Bursts at 5Hz) /
Tra
Sponsors
All India Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: The patient must meet all of the following inclusion criteria to be eligible for enrolment into the study Demographic: 1.Children and adolescents (Male or female) aged 5-14 years, both included. Diagnostic: 2. Epilepsy for atleast 1 year 3. Seizures of single semiology 4. Has an Epilepsy diagnosis of either ? Drug refractory focal epilepsy OR ? Electrical status epilepticus in sleep syndrome of structural aetiology 5. Majority (75%) of Interictal epileptiform discharges arising over a single epileptogenic focus on sleep EEG 6. An identifiable structural or functional lesion on MRI brain or interictal PET respectively Drug refractory focal epilepsy will be defined as = 1 focal seizure / week or 4 focal seizures/month for atleast three months despite on = 2 appropriately chosen and optimally prescribed antiepileptic drugs Structural ESES • Sleep and awake EEG showing sleep potentiation of interictal discharges with spike wave index (percentage of spikes-and-waves during the first 10 minutes of sleep, just after alpha dropout) of = 50% • Cognitive decline/ language regression with neuropsychiatric manifestations with or without ongoing seizures. • Structural correlate: A structural or functional lesion on imaging Procedural 7.Parent/legal guardian has provided written consent for participation in the study. 8.Parent/legal guardian is cooperative, willing to complete all aspects of the study
Exclusion criteria
Exclusion criteria: 1. Lack of clarity on the Epileptogenic focus on standard evaluation with MRI brain epilepsy protocol, Video EEG and PET CT head 2. Diagnosed as progressive neurological disorder 3. Previous epilepsy surgery or vagal nerve stimulation insertion. 4. Patient waitlisted for epilepsy surgery within 2 months 5. Critical illness/ comorbidities at the time of inclusion 6. Contraindications for TMS like implanted electronic device and non-removable metallic devices (Pacemaker, cochlear implant) or any ferromagnetic metal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome Variables: 1. Mean change in RMT and MEP as measured before cTBS session and at 60 ± 5min after the last session. 2. Mean change in RMT and MEP as measured before rTMS session and at 60 ± 5min after the last session. Timepoint: Change in RMT and MEP from baseline when measured at 60 ± 5min post last session (day 3 of week 1 of Intervention phase and day 3 of week 6 of intervention phase) after cTBS and rTMS. | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the effect of a three-day session of targeted cTBS as compared to a three day session of targeted conventional low frequency rTMS on intracortical inhibition measured as short interval cortical inhibition (SICI) and long interval cortical inhibition (LICI) in children and adolescents aged 5-14 years with Lesional drug refractory Epilepsy (Focal epilepsy or electrical status epilepticus in sleep) at baseline, 15 -30 minutes, 60± 5 minutes and 24 ± 2 hours post stimulation. Outcome variables : Short intracortical inhibition (SICI) Long intracortical inhibition (LICI)Timepoint: SICI and LICI measured at baseline, 15 -30 minutes, 60± 5 minutes and 24 ± 2 hours post stimulation;To determine the modulating effect of a three-day session of targeted (epileptogenic focus) cTBS as compared to a three-day session of targeted low frequency rTMS on cortical excitability in children and adolescents aged 5-14 years with Lesional Drug refractory Epilepsy (Focal epilepsy or electrical status epilepticus in sleep) in terms of change in RMT and MEP from baseline when measured at 15-30 min and 24± 2 hours post last session. Outcome Variables: 1. Mean change in RMT as measured before cTBS session and at 15-30 min and 24 ± 2 hours after the last session. 2. Mean change in RMT as measured before rTMS session and at 15 -30 min and 24 ± 2 hours after the last session. 3.Change in percentage of maximal MEP as measured before cTBS session and at 15-30 min and 24 ± 2 hours after the last session. 4. Change in percentage of maximal MEP as measured before rTMS session and at 15-30 min and 24 ± 2 hours after the last session.Timepoint: Change in RMT and MEP from baseline when measured at 15-30 min and 24± 2 hours post last session.;To document the change in Spike wave index (SWI) in a sleep EEG when recorded b/w 6-12 hours after the last stimulation session as compared to baseline record. Outcome Variables : Change in Spike wave index in sleep EEG recordTimep | — |
Countries
India
Contacts
Public ContactDr Kaushik R
All India Institute of Medical Sciences , New Delhi
Outcome results
None listed