Sleep Spindles and Memory in Rolandic Epilepsy

NCT ID: NCT04569708

Last Updated: 2024-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-16

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Rolandic Epilepsy Rolandic Epilepsy, Benign Centrotemporal Epilepsy Centrotemporal; EEG Spikes, Epilepsy of Childhood Epilepsy; Seizure Epilepsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Children and adolescents with epilepsy and controls

Closed loop auditory stimulation during nap

Group Type EXPERIMENTAL

Auditory stimulation

Intervention Type OTHER

Quiet auditory stimulation timed with sleep physiology

Interventions

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Auditory stimulation

Quiet auditory stimulation timed with sleep physiology

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Boston University

OTHER

Sponsor Role collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Catherine Chu, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Catherine Chu, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Athinoula A. Martinos Center Biomedical Imaging

Charlestown, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Catherine Chu, MD

Role: CONTACT

617-726-6540

Erin Berja, BS

Role: CONTACT

631-317-0413

Facility Contacts

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Catherine J Chu, MD

Role: primary

617-726-6540

Erin Berja, BS

Role: backup

631-317-0413

Other Identifiers

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1R01NS115868-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2020P002668

Identifier Type: -

Identifier Source: org_study_id

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