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Completed

NCT Number: NCT04325282

Transcranial Magnetic Stimulation for BECTS

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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Key information

Conditions

Benign Epilepsy With Centrotemporal Spikes Brain Diseases Central Nervous System Diseases Communication Disorders Epilepsies, Partial Epilepsy Epilepsy, Rolandic Epileptic Syndromes Language Problems Learning Disabilities Learning Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Palo Alto, California, 94304, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Active rTMS

Device

1Hz rTMS delivered for 15-20 minutes

sham rTMS

Device

sham rTMS delivered for 15-20 minutes

Primary outcomes

  1. Interictal Epileptiform Discharge (IED) Frequency

    Time frame: Before and after intervention (approximately 4 hours/visit on 2 study days one week apart)

    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.

Secondary outcomes

  1. Change in Brain Connectivity

    Time frame: Before and after intervention (approximately 4 hours/visit on 2 study days one week apart)

    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. We chose 3 regions of interest per hemisphere (-F: Frontal, -M: Motor, -T: Temporal). rTMS was applied to the hemisphere with more spikes on clinical EEG, and hence all regions were further qualified as being ipsilateral (i-) or contralateral (c-) to rTMS application.

    Connectivity is measured in the weighted Phase Lag Index (wPLI) in the beta-frequency band, a phase-based connectivity measure which runs from a theoretical minimum of 0 (no connectivity) to 1 (complete connectivity).

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Official study title

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

Acronym: TMS4BECTS

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Mar 27, 2020
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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