Transcranial Magnetic Stimulation for BECTS

Study Overview
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Brief Summary
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Benign epilepsy with centrotemporal spikes (BECTS) is the most common pediatric epilepsy syndrome. Affected children typically have a mild seizure disorder, but yet have moderate difficulties with language, learning and attention that impact quality of life more than the seizures. Separate from the seizures, these children have very frequent abnormal activity in their brain known as interictal epileptiform discharges (IEDs, or spikes), which physicians currently do not treat. These IEDs arise near the motor cortex, a region in the brain that controls movement. In this study, the investigators will use a form of non-invasive brain stimulation called transcranial magnetic stimulation (TMS) to determine the impact of IEDs on brain regions important for language to investigate: (1) if treatment of IEDs could improve language; and (2) if brain stimulation may be a treatment option for children with epilepsy. Participating children will wear electroencephalogram (EEG) caps to measure brain activity. The investigators will use TMS to stimulate the brain region where the IEDs originate to measure how this region is connected to other brain regions. Children will then receive a special form of TMS called repetitive TMS (rTMS) that briefly reduces brain excitability. The study will measure if IEDs decrease and if brain connectivity changes after rTMS is applied. The investigators hypothesize that the IEDs cause language problems by increasing connectivity between the motor cortex and language regions. The investigators further hypothesize that rTMS will reduce the frequency of IEDs and also reduce connectivity between the motor and language region

Official Title
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Impact of Repetitive Transcranial Magnetic Stimulation (TMS) on Spike Frequency and Brain Connectivity in Children With Benign Epilepsy With Centrotemporal Spike (BECTS)

Conditions
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Benign Epilepsy With Centrotemporal Spikes, Language Problems, Learning Disorders

Intervention / Treatment
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* Device: Active rTMS
* Device: Sham rTMS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A diagnosis of Benign Epilepsy with Centrotemporal Spikes (BECTS), sometimes called Rolandic Epilepsy. Diagnosis will be based on a history of a focal motor seizure (affecting the face or causing hypersalivation) or a history of a seizure out of sleep AND an EEG with unilateral or bilateral centrotemporal spike waves. English-speaking Exclusion Criteria: History of prematurity < 35 weeks gestational age; History of serious neurologic problems (i.e. history of other seizure disorder other than simple febrile seizure, head trauma with prolonged loss of consciousness, cerebrovascular accident or neuro-inflammatory disease) Focal deficits on neurologic exam History of abnormal MRI (with clear gray or white matter abnormality)

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: Children will receive active repetitive TMS (rTMS) on one day and sham stimulation on a second day. The order of stimulation will be randomized on a per-participant basis. Children and parents/guardians will not be told if they are receiving sham or inhibitory rTMS on a given day. The research team will know at the time of stimulation, however, as they will have to choose which coil to use. The TMS-EEG files will be coded and the team member analyzing the files for change in IED (spike) frequency and change in connectivity will be blinded to condition.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Children with BECTS<br>Children will receive sham and active rTMS on 2 separate study visits separated by at least 1 week. | Device: Active rTMS<br>* 1Hz rTMS delivered for 15-20 minutes<br>Device: Sham rTMS<br>* sham rTMS delivered for 15-20 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interictal Epileptiform Discharge (IED) Frequency | We will count the number of IEDs/minute before and after application of active rTMS as well as before and after sham rTMS. We will compare the change in IEDs induced by the active and sham stimulation. | Before and after intervention (approximately 4 hours/visit on 2 study days one week apart) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Brain Connectivity | We will measure brain connectivity before and after application of active rTMS as well as before and after sham rTMS. We will compare the change in connectivity induced by the active and sham stimulation. In particular, we will look at how connectivity changes between the motor cortex and language regions of the brain. | Before and after intervention (approximately 4 hours/visit on 2 study days one week apart) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcranial Magnetic Stimulation (TMS), Electroencephalogram (EEG), Children, Pediatric, Interictal Epileptiform Discharges, Brain connectivity