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Auditory Stimulation for Rolandic Epilepsy
N/A
Recruiting
Led By Catherine Chu, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has had at least 1 focal motor or generalized seizure
Diagnosed with childhood epilepsy with centrotemporal spikes (CECTS) or Rolandic epilepsy by child neurologist
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-5 hours
Awards & highlights
Study Summary
This trial is for children with Rolandic epilepsy and those without it, to see how different brain imaging techniques show brain activity in children with epilepsy.
Who is the study for?
This trial is for children aged 4-18 with Rolandic epilepsy, who've had at least one seizure and show specific brain activity patterns on an EEG. It's not for those with abnormal MRIs, other neurological diseases, metal implants or braces, claustrophobia, a history of frequent vomiting, or over the MRI weight limit.Check my eligibility
What is being tested?
The study is testing auditory stimulation in kids with Rolandic epilepsy using non-invasive brain imaging techniques like MRI and MEG/EEG to understand affected brain circuits and rhythms. The goal is to find new treatments for childhood epilepsy.See study design
What are the potential side effects?
Since this trial involves non-invasive imaging and experimental tasks without medication intervention, significant side effects are not expected. However, discomfort from wearing EEG equipment or lying still during scans may occur.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had at least one seizure.
Select...
I have been diagnosed with Rolandic epilepsy by a child neurologist.
Select...
I am between 4 and 18 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1-5 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-5 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Memory performance
Spindle Density
Other outcome measures
Spindle-slow oscillation coupling
Trial Design
1Treatment groups
Experimental Treatment
Group I: Children and adolescents with epilepsy and controlsExperimental Treatment1 Intervention
Closed loop auditory stimulation during nap
Find a Location
Who is running the clinical trial?
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,341 Previous Clinical Trials
650,039 Total Patients Enrolled
77 Trials studying Epilepsy
24,853 Patients Enrolled for Epilepsy
Massachusetts General HospitalLead Sponsor
2,936 Previous Clinical Trials
13,198,621 Total Patients Enrolled
8 Trials studying Epilepsy
538 Patients Enrolled for Epilepsy
Boston UniversityOTHER
456 Previous Clinical Trials
9,941,632 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I weigh less than or equal to 350lbs.I often experience vomiting.You cannot have a magnetic resonance imaging (MRI) or magnetoencephalography (MEG) scan.You have permanent metal in your body, such as braces.You have an unusual brain MRI.I have had at least one seizure.You have a different neurological disease not related to the study.You have a specific abnormal brain wave pattern during sleep.You feel very uncomfortable in small or crowded spaces.I have been diagnosed with Rolandic epilepsy by a child neurologist.I am between 4 and 18 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Children and adolescents with epilepsy and controls
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.
Am I eligible to sign up for this experiment?
"100 participants aged between 4 and 18 with rolandic epilepsy of the benign type must be sourced for this clinical trial. Additionally, these patients need to have experienced at least one focal motor or generalized seizure as well as an EEG report showing sleep activated centrotemporal spikes that has been verified by a child neurologist."
Answered by AI
What is the upper limit of participants in this research project?
"Correct. Clinicaltrials.gov confirms that enrollment for this medical investigation, which was initially posted on the 16th of January 2021, is still ongoing. Around one hundred individuals must be recruited from a single location to complete the study's aims."
Answered by AI
Are participants still being accepted for this experiment?
"Clinicaltrials.gov confirms that this medical trial is actively seeking participants with the original posting on January 16th 2021 and most recent update occurring April 4th 2022."
Answered by AI
Is the age threshold for this medical experiment greater than fifty years?
"Based on the conditions outlined in this study's inclusion criteria, participants must range in age from 4 to 18 years old."
Answered by AI
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