Health Condition 1: G998- Other specified disorders of nervous system in diseases classified elsewhere
Conditions
Interventions
Intervention1: Repeatitive Transcranial stimulus: Every enrolled patient after baseline workup will receive 3 cycles of rTMS
The rTMS will be given by machine make Magventure model no X100 with magopt
Sponsors
Child neurology division
Eligibility
Inclusion criteria
Inclusion criteria: 1.Diagnosed as ESES as per the study definition (SWI > 50%). 2.Fullfils study definition of steroid non-responsive/relapsing ESES 3. Received pulse methylprednisolone therapy more than 6 months back. 4.Stable on antiepileptic and antipsychotic regimen for 4 weeks prior to enrolment 5. Baseline log of weekly seizure frequency over last 4 weeks available (in children with ongoing seizures). 6.Parent/legal guardian has provided written consent for participation in the study. 7.Parent/legal guardian is cooperative, willing to complete all aspects of the study
Exclusion criteria
Exclusion criteria: Diagnosed progressive neurological disorder 2. Previous epilepsy surgery or vagal nerve stimulation insertion. 3. Presence of Metallic implants anywhere in the body. 4. Either Immunotherapy nai¨ve or have received immunotherapy for ESES within the last 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To estimate the proportion of children with steroid non responsive/relapsing ESES who achieve resolution of ESES with rTMS therapy at 16±2 weeks of therapy.Timepoint: Baseline,16±2 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To analyse the mean change in aggregated EEG score (ASES) from baseline, at 16 ± 2 and 24±2 weeks of rTMS therapy in children aged 5 -12 years with steroid non- responsive/relapsing ESES. Timepoint: Baseline,16±2 and 24±2 Weeks;To analyse the mean change in IQ/SQ from baseline, at 16 ± 2 and 24± 2 weeks of rTMS therapy in children aged 5 -12 years with steroid non-responsive/relapsing ESESTimepoint: Baseline,16±2 and 24± 2weeks;To analyse the pre and post rTMS therapy changes in functional MRI findings in terms of blood oxygen level dependent (BOLD) signals in steroid non- responsive/relapsing ESES at 16± 2 weeks.Timepoint: Baseline,16±2weeks;To analyse the pre and post rTMS therapy changes in positron emission tomography (PET) scan finding in steroid non-responsive/relapsing ESES at 16 ± 2 weeks.Timepoint: Baseline,16±2 weeks;To evaluate the effect of rTMS therapy on Caregiver-rated Impression of Change (CIC) from baselineTimepoint: Baseline,16±2weeks;To study the mean change in affected behavioural domain score on childhood behaviour checklist (CBCL)from baseline, at16±2 and 24±2 weeks of rTMS therapy in children aged 5-12 years with steroid non responsive /relapsing ESESTimepoint: Baseline,16±2 and 24±2 weeks;To study the mean reduction in weekly seizure frequency from baseline, at 16±2 and 24±2 weeks of rTMS therapy in children aged 5-12 years with steroid non responsive /relapsing ESES.Timepoint: Baseline,16±2 and 24±2weeks | — |
Countries
India
Contacts
Public ContactDr Ankit Kumar Meena
AIIMS, New Delhi
Outcome results
None listed