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Clinical Trials/CTRI/2022/09/045264
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
ICMRIndia

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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