TO assess the efficacy of repetitive transcranial magnetic stimulation in children with focal epilepsy which is refractory to multiple drugs

Phase 3

Conditions: Health Condition 1: G400- Localization-related (focal) (partial) idiopathic epilepsy and epileptic syndromes with seizures of localized onset

Registration Number: CTRI/2022/09/045264

Lead Sponsor: ICMRIndia

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

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)

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the proportion of children and <br/ ><br>adolescents between 5-18 years, with drug resistant <br/ ><br>focal epilepsy, who achieve 50% seizure reduction <br/ ><br>at week 15 of study period, compared to baseline, in <br/ ><br>both active and sham rTMS therapy groups.Timepoint: The primary outcome would be analyzed at 15 weeks from baseline (from the time of randomisation)

Secondary Outcome Measures