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

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

Study Contact Backup

Study Locations

    • Massachusetts
      • Charlestown, Massachusetts, United States, 02129
        • Recruiting
        • Athinoula A. Martinos Center Biomedical Imaging
        • Contact:
        • Contact:

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:

  1. Ages 4-18 years
  2. Diagnosed with childhood epilepsy with centrotemporal spikes (CECTS) or Rolandic epilepsy by child neurologist
  3. Has EEG with sleep activated centrotemporal spikes
  4. Has had at least 1 focal motor or generalized seizure

Exclusion Criteria:

  1. Has abnormal brain MRI
  2. Has other unrelated neurological disease
  3. Unable to have an MRI/MEG

    1. Claustrophobic
    2. History of frequent vomiting
    3. Permanent metal in body, braces
    4. 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.

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

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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