Benign Epilepsy With Centrotemporal SpikesTMS4BECTSNCT04325282

Transcranial Magnetic Stimulation for BECTS

A study testing Active rTMS in people with Benign Epilepsy With Centrotemporal Spikes and Language Problems, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 5 to 18 years
Conditions the study is for: Benign Epilepsy With Centrotemporal Spikes, Language Problems, Learning Disorders
What is being tested?: Active rTMS
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 22 participants
Where: 1 siteUnited States
Study dates: 28 Oct 2020to 3 Mar 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 5 to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

United States1 site

Stanford University School of Medicine
Palo Alto, California, 94304

Other trials in United States

About this study

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

Conditions: Benign Epilepsy With Centrotemporal Spikes, Language Problems, Learning Disorders
Being tested: Active rTMS, Sham rTMS
Keywords: Transcranial Magnetic Stimulation (TMS), Electroencephalogram (EEG), Children, Pediatric, Interictal Epileptiform Discharges, Brain connectivity
Medical subject headings: Epilepsy, Rolandic, Learning Disabilities

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Active rTMSDevice
1Hz rTMS delivered for 15-20 minutes
Sham rTMSDevice
sham rTMS delivered for 15-20 minutes

Study groups in NCT04325282
Study group	Role	What they receive
Children with BECTS	Experimental	Children will receive sham and active rTMS on 2 separate study visits separated by at least 1 week. Receives: Device: Active rTMS; Device: Sham rTMS

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Oct 20203 Mar 2024

First posted27 Mar 2020
Study start28 Oct 2020
Primary completion3 Mar 2024
Study completion3 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Benign Epilepsy With Centrotemporal SpikesStudies of the same condition, open and under way.
More trials run by Stanford UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
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)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04325282
Sponsor's protocol ID: 37514
Other IDs: K23NS116110
Acronym: TMS4BECTS
Status last verified: Aug 2025
First submitted: 25 Mar 2020
Last updated: 4 Sep 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No: No current plan.

Publications

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.
PubMed 32142025
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.
PubMed 31942753
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.
PubMed 27513825
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.
PubMed 40010636
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.
PubMed 38641629

Study at a glance

From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of Repetitive Transcranial Magnetic Stimulation (TMS) on Spike Frequency and Brain Connectivity in Children With Benign Epilepsy With Centrotemporal Spike (BECTS)
ClinicalTrials.gov ID: NCT04325282
Acronym / sponsor ID: TMS4BECTS / 37514
Conditions: Benign Epilepsy With Centrotemporal Spikes, Language Problems, Learning Disorders
Keywords: Transcranial Magnetic Stimulation (TMS), Electroencephalogram (EEG), Children, Pediatric, Interictal Epileptiform Discharges, Brain connectivity
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
Study start: 28 Oct 2020 (actual)
Primary completion: 3 Mar 2024 (actual)
Study completion: 3 Mar 2024 (actual)
First posted: 27 Mar 2020 (actual)
Results: Posted 4 Sep 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
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.

Arm	Type	Receives
Children with BECTS	Experimental	Device: Active rTMS, Device: Sham rTMSChildren will receive sham and active rTMS on 2 separate study visits separated by at least 1 week.

Who may qualify

Ages: 5 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (4 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Active rTMS1Hz rTMS delivered for 15-20 minutes	Device	Children with BECTS
Sham rTMSsham rTMS delivered for 15-20 minutes	Device	Children with BECTS

Primary outcome

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.

1 secondary outcome

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

Results and safety

Results posted to the registry on 4 Sep 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Children With SeLECTS - Active, Then Sham rTMS	11	11
Children With SeLECTS - Sham, Then Active rTMS	11	10

Primary outcome: Interictal Epileptiform Discharge (IED) Frequency

Time frame: Before and after intervention (approximately 4 hours/visit on 2 study days one week apart). Median (Inter-Quartile Range). Unit: IEDs per 5 minutes

Measure	Children With SeLECTS - Active rTMS n = 19	Children With SeLECTS - Sham rTMS n = 19
Before rTMS	0 (0 to 20.5)	0 (0 to 18)
After rTMS	0 (0 to 12)	0 (0 to 18.5)
Change from pre-rTMS to post-rTMS	0 (-6.5 to 0)	0 (-1 to 0)

Children With SeLECTS - Active rTMS: p = 0.04, Wilcoxon signed rank test
Children With SeLECTS - Sham rTMS: p = 0.46, Wilcoxon signed rank test
Children With SeLECTS - Active rTMS vs Children With SeLECTS - Sham rTMS: p = 0.12, Wilcoxon signed rank test

Population analysed: Participants with Analyzable Data (Remained awake for both active \& sham rTMS sessions)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 1 week. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Children With SeLECTS - Active rTMS	0 of 19 (0%)	2 of 19 (10.5%)	0 of 19
Children With SeLECTS - Sham rTMS	0 of 19 (0%)	0 of 19 (0%)	0 of 19

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 32142025Baumer 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.
Background: PubMed 31942753Mishra 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.
Background: PubMed 27513825Chen 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.
Results publication: PubMed 40010636She 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.
Results publication: PubMed 38641629She 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.
Individual participant dataSharing planned: No. No current plan.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Fiona M Baumer, MD principal investigator

Stanford University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Active rTMS in people with Benign Epilepsy With Centrotemporal Spikes and Language Problems, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Interictal Epileptiform Discharge (IED) Frequency (time frame: Before and after intervention (approximately 4 hours/visit on 2 study days one week apart)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04325282, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.