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OpenTrials
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NCT Number: NCT04569708

Sleep Spindles and Memory 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.

Why the study stopped: Subjects were never enrolled and PI moved
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Key information

Conditions

Rolandic Epilepsy Brain Diseases Central Nervous System Diseases Centrotemporal Epilepsy Centrotemporal; EEG Spikes, Epilepsy of Childhood Epilepsies, Partial Epilepsy Epilepsy, Rolandic Epilepsy; Seizure Epileptic Syndromes Nervous System Diseases Rolandic Epilepsy, Benign

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Athinoula A. Martinos Center Biomedical Imaging

Charlestown, Massachusetts, 02129, United States

About this study

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, or a sham. The auditory stimulus will be calibrated in volume to not cause arousals. After napping, subjects will undergo cognitive testing and memory task testing.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of childhood epilepsy with centrotemporal spikes (CECTS)or Rolandic epilepsy by child neurologist
  • Ages 4-18 years
  • Has an 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 due to claustrophobia, history of frequent vomiting, permanent metal in body (braces), or over MRI weight limit: 350lbs

Treatment and study plan

Closed loop auditory stimulation

Other

Quiet auditory stimulation timed with sleep physiology

Primary outcomes

  1. Spindle Density

    Time frame: 1-5 hours

    Spindle count per minute during non-rapid eye movement (NREM) sleep

  2. Memory performance

    Time frame: 1-5 hours

    Percent improvement in memory task performance

Other outcomes

  1. Spindle-slow oscillation coupling

    Time frame: 1-5 hours

    Cross frequency coupling

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Boston University
  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Official study title

Auditory Stimulation Effect on Spindles and Sleep Dependent Learning in Rolandic Epilepsy

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Sep 30, 2020
Registry last updated
Aug 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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