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Transcranial magnetic stimulation device for focal refractory epilepsy in childhood and adolescent

“A randomized double blind sham controlled trial of targeted low frequency repetitive transcranial magnetic stimulation (rTMS) therapy in childhood and adolescent with focal onset refractory epilepsy ?

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/02/017440
Enrollment
50
Registered
2019-02-05
Start date
Unknown
Completion date
Unknown
Last updated
2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: -

Interventions

Intervention1: rTMS: TMS is based on the principle of electromagnetic induction, in which an alternating electric current is passed through a stimulation coil, which is placed above the scalp. Another

Sponsors

Child neurology DivisionDepartment of AIIMSNew Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children and adolescents of either sex aged 5 -18 years diagnosed with focal onset drug refractory epilepsy as per with ILAE 2017. Drug refractory epilepsy will be defined as = 1 seizure / week OR 4 seizures/month despite on = 2 appropriately chosen and optimally prescribed antiepileptic drugs. 1. Duration of epilepsy for atleast 1 year 2. Seizures of single semiology 3. Majority (75%) of Interictal epileptiform discharges(SWI) arising over a single epileptogenic focus on sleep EEG Parents/ guardians willing to follow the treatment protocol of daily sessions for 10 days in 2 week with Sunday off and hospital follow up at 6 week and 10 weeks of total study period

Exclusion criteria

Exclusion criteria: 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) 3. Diagnosed progressive neurological disorder 4. Previous epilepsy surgery or vagal nerve stimulation insertion. 5. Patient waitlisted for epilepsy surgery within 6 months 6. Presence of Metallic implants anywhere in the body

Design outcomes

Primary

MeasureTime frame
Proportion of patients who achieve 50% seizure reduction from baseline at 8 weeks after rTMS therapy Timepoint: Proportion of patients who achieve 50% seizure reduction from baseline at 8 weeks after rTMS therapy

Secondary

MeasureTime frame
1.Proportion of patients who achieve 50% reduction in SWI on sleep EEG from baseline at 8 weeks after rTMS therapy 2.Change in cortical excitability induced by rTMS thrapy in terms of pre and post therapy change in motor threshold (MT), short-interval intracortical inhibition (SICI) and long- interval intracortical inhibition (LICI) by single pulse TMS 3.Effect of rTMS on the behavioural profile (as per CBCL) and cognition (MISIC) Timepoint: 8 weeks from baseline

Countries

India

Contacts

Public ContactDr Rahul Sinha

AIIMS,New Delhi

pjauhari0@gmail.com9914521820

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026