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Transcranial Magnetic Stimulation for Rolandic Epilepsy (TMS4BECTS Trial)

N/A
Recruiting
Led By Fiona M Baumer, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of Benign Epilepsy with Centrotemporal Spikes (BECTS), sometimes called Rolandic Epilepsy. Diagnosis based on a history of a focal motor seizure or a seizure out of sleep AND an EEG with unilateral or bilateral centrotemporal spike waves
Be younger than 65 years old
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before and after intervention (approximately 4 hours/visit on 2 study days one week apart)
Awards & highlights

Summary

This trial will test if treating IEDs in children with epilepsy can improve language skills by using transcranial magnetic stimulation (TMS) to stimulate the brain region where the IEDs originate.

Who is the study for?
This trial is for English-speaking children diagnosed with Benign Epilepsy with Centrotemporal Spikes (BECTS), also known as Rolandic Epilepsy, based on specific seizure history and EEG results. It excludes those born prematurely (<35 weeks), with serious neurological issues, focal deficits in neuro exams, or abnormal MRI findings.
What is being tested?
The study tests transcranial magnetic stimulation (TMS) to see if it can improve language by treating brain activity disruptions caused by BECTS. Children will receive repetitive TMS (rTMS) to potentially reduce these disruptions and change how the motor cortex connects to language regions.
What are the potential side effects?
While rTMS is generally considered safe, potential side effects may include discomfort at the stimulation site, headache, lightheadedness, or rarely seizures. The impact on mood and cognition are also being studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Rolandic Epilepsy based on my seizure history and EEG results.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had serious brain or nerve problems like seizures, severe head injuries, strokes, or diseases causing brain inflammation.
Select...
I have specific areas of weakness or loss of function.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~before and after intervention (approximately 4 hours/visit on 2 study days one week apart)
This trial's timeline: 3 weeks for screening, Varies for treatment, and before and after intervention (approximately 4 hours/visit on 2 study days one week apart) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Interictal Epileptiform Discharge (IED) Frequency
Secondary study objectives
Change in Brain Connectivity

Side effects data

From 2022 Phase 2 trial • 72 Patients • NCT03144232
11%
Headache
9%
Fatigue
3%
Mood Swings
3%
Hand numbness
3%
Insomnia
3%
Anxiety
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sham rTMS
Repetitive Transcranial Magnetic Stimulation (rTMS)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Children with BECTSExperimental Treatment2 Interventions
Children will receive sham and active rTMS on 2 separate study visits separated by at least 1 week.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sham rTMS
2008
Completed Phase 3
~1020
Active rTMS
2019
Completed Phase 2
~400

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,448 Previous Clinical Trials
17,492,358 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,362 Previous Clinical Trials
650,714 Total Patients Enrolled
Fiona M Baumer, MDPrincipal InvestigatorStanford University

Media Library

Active rTMS Clinical Trial Eligibility Overview. Trial Name: NCT04325282 — N/A
Rolandic Epilepsy Research Study Groups: Children with BECTS
Rolandic Epilepsy Clinical Trial 2023: Active rTMS Highlights & Side Effects. Trial Name: NCT04325282 — N/A
Active rTMS 2023 Treatment Timeline for Medical Study. Trial Name: NCT04325282 — N/A
~1 spots leftby Dec 2024
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