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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
Must not have
Over MRI weight limit: 350lbs
History of frequent vomiting
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-5 hours
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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I have had at least one seizure.
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I have been diagnosed with Rolandic epilepsy by a child neurologist.
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I am between 4 and 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I weigh less than or equal to 350lbs.
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I often experience vomiting.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-5 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-5 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Memory performance
Spindle Density
Other study objectives
Spindle-slow oscillation coupling

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
1,385 Previous Clinical Trials
652,588 Total Patients Enrolled
79 Trials studying Epilepsy
25,461 Patients Enrolled for Epilepsy
Boston UniversityOTHER
478 Previous Clinical Trials
9,994,710 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
3,026 Previous Clinical Trials
13,413,720 Total Patients Enrolled
8 Trials studying Epilepsy
538 Patients Enrolled for Epilepsy
Catherine Chu, MDPrincipal Investigator - Massachusetts General Hospital
Massachusetts General Hospital
Harvard Medical School (Residency)
1 Previous Clinical Trials
30 Total Patients Enrolled

Media Library

Auditory stimulation Clinical Trial Eligibility Overview. Trial Name: NCT04569708 — N/A
Epilepsy Research Study Groups: Children and adolescents with epilepsy and controls
Epilepsy Clinical Trial 2023: Auditory stimulation Highlights & Side Effects. Trial Name: NCT04569708 — N/A
Auditory stimulation 2023 Treatment Timeline for Medical Study. Trial Name: NCT04569708 — N/A
~20 spots leftby Dec 2025
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