Transcranial Magnetic Stimulation for BECTS

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-28

Study Completion Date

2024-03-03

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

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Detailed Description

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Conditions

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Benign Epilepsy With Centrotemporal Spikes Language Problems Learning Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Children with BECTS

Children will receive sham and active rTMS on 2 separate study visits separated by at least 1 week.

Group Type EXPERIMENTAL

Active rTMS

Intervention Type DEVICE

1Hz rTMS delivered for 15-20 minutes

Sham rTMS

Intervention Type DEVICE

sham rTMS delivered for 15-20 minutes

Interventions

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Active rTMS

1Hz rTMS delivered for 15-20 minutes

Intervention Type DEVICE

Sham rTMS

sham rTMS delivered for 15-20 minutes

Intervention Type DEVICE

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)

Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No