Clinical trial NCT04325282: Transcranial Magnetic Stimulation for BECTS
Official title: Impact of Repetitive Transcranial Magnetic Stimulation (TMS) on Spike Frequency and Brain Connectivity in Children With Benign Epilepsy With Centrotemporal Spike (BECTS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Benign Epilepsy With Centrotemporal Spikes
Language Problems
Learning Disorders
Keywords: Transcranial Magnetic Stimulation (TMS)
Electroencephalogram (EEG)
Children
Pediatric
Interictal Epileptiform Discharges
Brain connectivity
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2020-03-27
Enrollment: 36
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: BASIC_SCIENCE

Brief summary: 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


Eligibility criteria: 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)

Primary outcomes:
measure: Interictal Epileptiform Discharge (IED) Frequency
timeFrame: Before and after intervention (approximately 4 hours/visit on 2 study days one week apart)
Secondary outcomes:
measure: Change in Brain Connectivity
timeFrame: Before and after intervention (approximately 4 hours/visit on 2 study days one week apart)
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Fiona M Baumer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baumer FM, Pfeifer K, Fogarty A, Pena-Solorzano D, Rolle CE, Wallace JL, Rotenberg A, Fisher RS. Cortical Excitability, Synaptic Plasticity, and Cognition in Benign Epilepsy With Centrotemporal Spikes: A Pilot TMS-EMG-EEG Study. J Clin Neurophysiol. 2020 Mar;37(2):170-180. doi: 10.1097/WNP.0000000000000662.
citation: Mishra A, Maiti R, Mishra BR, Jena M, Srinivasan A. Effect of Repetitive Transcranial Magnetic Stimulation on Seizure Frequency and Epileptiform Discharges in Drug-Resistant Epilepsy: A Meta-Analysis. J Clin Neurol. 2020 Jan;16(1):9-18. doi: 10.3988/jcn.2020.16.1.9.
citation: Chen R, Spencer DC, Weston J, Nolan SJ. Transcranial magnetic stimulation for the treatment of epilepsy. Cochrane Database Syst Rev. 2016 Aug 11;(8):CD011025. doi: 10.1002/14651858.CD011025.pub2.