Transcranial Magnetic Stimulation for BECTS

NCT04325282 | Completed Results FDA Device

• 2 other identifiers: 37514K23NS116110
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Conditions

Benign Epilepsy With Centrotemporal Spikes; Language Problems; Learning Disorders

Keywords

Transcranial Magnetic Stimulation (TMS); Electroencephalogram (EEG); Children; Pediatric; Interictal Epileptiform Discharges; Brain connectivity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Brain Connectivity

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

Study Arms (1)

Children with BECTS

EXPERIMENTAL

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

Device: Active rTMS; Device: Sham rTMS

Interventions

Active rTMS DEVICE

1Hz rTMS delivered for 15-20 minutes

Children with BECTS

Sham rTMS DEVICE

sham rTMS delivered for 15-20 minutes

Children with BECTS

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Stanford University: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Stanford University School of Medicine

Palo Alto, California, 94304, United States

Location

Related Publications (5)

• 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.

  PMID: 32142025 BACKGROUND

• 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.

  PMID: 31942753 BACKGROUND

• 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.

  PMID: 27513825 BACKGROUND

• She X, Qi W, Nix KC, Menchaca M, Cline CC, Wu W, He Z, Baumer FM. Repetitive transcranial magnetic stimulation modulates brain connectivity in children with self-limited epilepsy with centrotemporal spikes. Brain Stimul. 2025 Mar-Apr;18(2):287-297. doi: 10.1016/j.brs.2025.02.018. Epub 2025 Feb 24.

  PMID: 40010636 RESULT

• She X, Nix KC, Cline CC, Qi W, Tugin S, He Z, Baumer FM. Stability of transcranial magnetic stimulation electroencephalogram evoked potentials in pediatric epilepsy. Sci Rep. 2024 Apr 20;14(1):9045. doi: 10.1038/s41598-024-59468-8.

  PMID: 38641629 RESULT

MeSH Terms

Conditions

Epilepsy, Rolandic; Learning Disabilities

Condition Hierarchy (Ancestors)

Epilepsies, Partial; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Fiona Baumer, MD, MS
• Organization: Stanford University

fbaumer@stanford.edu

(650) 723-0993

Study Officials

• Fiona M Baumer, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor

Model Details: 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.

Study Record Dates

• First Submitted: March 25, 2020
• First Posted: March 27, 2020
• Study Start: October 28, 2020
• Primary Completion: March 3, 2024
• Study Completion: March 3, 2024
• Last Updated: September 4, 2025
• Results First Posted: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)