CTRI/2022/09/045264
Recruiting
Phase 3
Intermediate and long-term therapeutic efficacy of rTMS in drug refractory focalepilepsy of childhood: A Randomized, Double-blind, Sham-Controlled study
ICMRIndia0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: G400- Localization-related (focal) (partial) idiopathic epilepsy and epileptic syndromes with seizures of localized onset
- Sponsor
- ICMRIndia
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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)
Outcomes
Primary Outcomes
Not specified
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