A comparison of two modalities of Trans cranial Magnetic Stimulation on the excitability brain in children and adolescents aged 5-14years with Drug refractory Epilepsy

Phase 2

• Conditions: Health Condition 1: G402- Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with complex partial seizures

• Registration Number: CTRI/2022/09/045152
• Lead Sponsor: All India Institute of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

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

OR

? 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

Procedural

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Outcome Variables: <br/ ><br>1. Mean change in RMT and MEP as measured before cTBS session and at 60 ± 5min after the last session. <br/ ><br>2. Mean change in RMT and MEP as measured before rTMS session and at 60 ± 5min after the last session. <br/ ><br>Timepoint: Change in RMT and MEP from baseline when measured at 60 ± 5min post last session (day 3 of week 1 of Intervention phase and day 3 of week 6 of intervention phase) after cTBS and rTMS.