- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04569708
Sleep Spindles and Memory in Rolandic Epilepsy
June 1, 2023 updated by: Catherine Chu, MD, Massachusetts General Hospital
Auditory Stimulation Effect on Spindles and Sleep Dependent Learning in Rolandic Epilepsy
The investigators are recruiting children with Rolandic epilepsy and children without epilepsy (aged 4 years old and above) for a non-invasive brain imaging study using Magnetic Resonance Imaging (MRI), Magnetoencephalography/Electroencephalography (MEG/EEG), and experimental tasks.
The investigators hope to determine the brain circuits and brain rhythms affected in these children and ultimately identify new treatment options for childhood epilepsy patients.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
This is a prospective study of epilepsy biomarkers in a total of 100 subjects of ages 4-18.
Participants will spend about 5 hours at the Massachusetts General Hospital (MGH) Athinoula A. Martinos Center for Biomedical Imaging.
They will undergo training on a memory task concurrent with EEG/MEG recordings.
During the EEG, subjects will wear headphones that will deliver a quiet pink noise stimulus intermittently during a nap.
The auditory stimulus will be calibrated in volume to not cause arousals.
After napping, subjects will undergo cognitive testing and memory task testing.
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Catherine Chu, MD
- Phone Number: 617-726-6540
- Email: cjchu@mgh.harvard.edu
Study Contact Backup
- Name: Erin Berja, BS
- Phone Number: 631-317-0413
- Email: eberja@mgh.harvard.edu
Study Locations
-
-
Massachusetts
-
Charlestown, Massachusetts, United States, 02129
- Recruiting
- Athinoula A. Martinos Center Biomedical Imaging
-
Contact:
- Erin Berja, BS
- Phone Number: 631-317-0413
- Email: eberja@mgh.harvard.edu
-
Contact:
- Catherine J Chu, MD
- Phone Number: 617-726-6540
- Email: cjchu@mgh.harvard.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Ages 4-18 years
- Diagnosed with childhood epilepsy with centrotemporal spikes (CECTS) or Rolandic epilepsy by child neurologist
- Has EEG with sleep activated centrotemporal spikes
- Has had at least 1 focal motor or generalized seizure
Exclusion Criteria:
- Has abnormal brain MRI
- Has other unrelated neurological disease
Unable to have an MRI/MEG
- Claustrophobic
- History of frequent vomiting
- Permanent metal in body, braces
- Over MRI weight limit: 350lbs
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Children and adolescents with epilepsy and controls
Closed loop auditory stimulation during nap
|
Quiet auditory stimulation timed with sleep physiology
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Spindle Density
Time Frame: 1-5 hours
|
Spindle count per minute during non-rapid eye movement (NREM) sleep
|
1-5 hours
|
Memory performance
Time Frame: 1-5 hours
|
Percent improvement in memory task performance
|
1-5 hours
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Spindle-slow oscillation coupling
Time Frame: 1-5 hours
|
Cross frequency coupling
|
1-5 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Catherine Chu, MD, Massachusetts General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 16, 2021
Primary Completion (Estimated)
December 31, 2025
Study Completion (Estimated)
December 31, 2025
Study Registration Dates
First Submitted
September 24, 2020
First Submitted That Met QC Criteria
September 24, 2020
First Posted (Actual)
September 30, 2020
Study Record Updates
Last Update Posted (Actual)
June 5, 2023
Last Update Submitted That Met QC Criteria
June 1, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020P002668
- 1R01NS115868-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Derivative data will be shared with appropriate IRB approval per publication requirements
IPD Sharing Time Frame
2020 - 2030
IPD Sharing Access Criteria
In accordance with IRB approval
IPD Sharing Supporting Information Type
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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