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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
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
TMS4BECTS Trial 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.Check my eligibility
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.See study design
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.
TMS4BECTS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Rolandic Epilepsy based on my seizure history and EEG results.
TMS4BECTS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ before and after intervention (approximately 4 hours/visit on 2 study days one week apart)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~before and after intervention (approximately 4 hours/visit on 2 study days one week apart)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Interictal Epileptiform Discharge (IED) Frequency
Secondary outcome measures
Change in Brain Connectivity
Side effects data
From 2022 Phase 2 trial • 72 Patients • NCT0314423227%
Headache
16%
Fatigue
3%
Eye twitch
3%
Jaw Pain
3%
Site discomfort
100%
80%
60%
40%
20%
0%
Study treatment Arm
Repetitive Transcranial Magnetic Stimulation (rTMS)
Sham rTMS
TMS4BECTS 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
~350
Find a Location
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,393 Previous Clinical Trials
17,341,521 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,340 Previous Clinical Trials
649,328 Total Patients Enrolled
Fiona M Baumer, MDPrincipal InvestigatorStanford University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had an MRI that showed unusual changes in your brain.I have been diagnosed with Rolandic Epilepsy based on my seizure history and EEG results.I have specific areas of weakness or loss of function.I have had serious brain or nerve problems like seizures, severe head injuries, strokes, or diseases causing brain inflammation.You were born earlier than 35 weeks of pregnancy.
Research Study Groups:
This trial has the following groups:- Group 1: Children with BECTS
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
At what age range is this clinical trial looking for participants?
"The age range that is eligible for this study according to the current set of inclusion criteria is 5 to 18 years old."
Answered by AI
Could I be a candidate for this research project?
"The current clinical trial has an age limit of 18 years old, with a lower bound of 5 years old. This research project is looking for 36 total patients that have been diagnosed with learning disorders."
Answered by AI
Are there any unfilled appointments for this clinical research?
"The trial, which was initially posted on October 28th 2020, is looking for volunteers according to the latest update from clinicaltrials.gov on May 3rd 2022."
Answered by AI
How many participants will be included in this experiment?
"That is correct, the information available on clinicaltrials.gov suggests that this trial is actively looking for patients to enroll. The postings says that the trial was first put up on 10/28/2020 and edited last on 5/3/2022. They are currently 36 people needed between 1 sites."
Answered by AI
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