Intermediate and long-term therapeutic efficacy of rTMS in drug refractory focalepilepsy of childhood: A Randomized, Double-blind, Sham-Controlled study

ICMRIndia0 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

试验速览

暂无简介。

•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.

•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

发起方

ICMRIndia