A comparison of modulating effect of cTBS and low frequency rTMS on cortical excitability in children and adolescents aged 5-14 years with Lesional Drug refractory Epilepsy (Focal epilepsy orelectrical status epilepticus in sleep): An open label randomized non-inferiority crossover study

All India Institute of Medical Sciences0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年10月16日

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•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
•? 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
•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

•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

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