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Sleep Spindles and Memory in Rolandic Epilepsy

Primary Purpose

Rolandic Epilepsy, Rolandic Epilepsy, Benign, Centrotemporal Epilepsy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Auditory stimulation
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Rolandic Epilepsy

Eligibility Criteria

4 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Athinoula A. Martinos Center Biomedical ImagingRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Children and adolescents with epilepsy and controls

Arm Description

Closed loop auditory stimulation during nap

Outcomes

Primary Outcome Measures

Spindle Density
Spindle count per minute during non-rapid eye movement (NREM) sleep
Memory performance
Percent improvement in memory task performance

Secondary Outcome Measures

Full Information

First Posted
September 24, 2020
Last Updated
June 1, 2023
Sponsor
Massachusetts General Hospital
Collaborators
Boston University, National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT04569708
Brief Title
Sleep Spindles and Memory in Rolandic Epilepsy
Official Title
Auditory Stimulation Effect on Spindles and Sleep Dependent Learning in Rolandic Epilepsy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 16, 2021 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Boston University, National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rolandic Epilepsy, Rolandic Epilepsy, Benign, Centrotemporal Epilepsy, Centrotemporal; EEG Spikes, Epilepsy of Childhood, Epilepsy; Seizure, Epilepsy

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Children and adolescents with epilepsy and controls
Arm Type
Experimental
Arm Description
Closed loop auditory stimulation during nap
Intervention Type
Other
Intervention Name(s)
Auditory stimulation
Intervention Description
Quiet auditory stimulation timed with sleep physiology
Primary Outcome Measure Information:
Title
Spindle Density
Description
Spindle count per minute during non-rapid eye movement (NREM) sleep
Time Frame
1-5 hours
Title
Memory performance
Description
Percent improvement in memory task performance
Time Frame
1-5 hours
Other Pre-specified Outcome Measures:
Title
Spindle-slow oscillation coupling
Description
Cross frequency coupling
Time Frame
1-5 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine Chu, MD
Phone
617-726-6540
Email
cjchu@mgh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Erin Berja, BS
Phone
631-317-0413
Email
eberja@mgh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Chu, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Athinoula A. Martinos Center Biomedical Imaging
City
Charlestown
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine J Chu, MD
Phone
617-726-6540
Email
cjchu@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Erin Berja, BS
Phone
631-317-0413
Email
eberja@mgh.harvard.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

Sleep Spindles and Memory in Rolandic Epilepsy

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