Sleep Spindles and Memory in Rolandic Epilepsy

NCT04569708 | Completed

• 2 other identifiers: 2020P0026681R01NS115868-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Spindle Density

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

  1-5 hours

• Memory performance

  Percent improvement in memory task performance

  1-5 hours

Other Outcomes (1)

• Spindle-slow oscillation coupling

  1-5 hours

Study Arms (1)

Children and adolescents with epilepsy and controls

EXPERIMENTAL

Closed loop auditory stimulation during nap

Other: Auditory stimulation

Interventions

Auditory stimulation OTHER

Quiet auditory stimulation timed with sleep physiology

Children and adolescents with epilepsy and controls

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Boston University: collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Athinoula A. Martinos Center Biomedical Imaging

Charlestown, Massachusetts, 02129, United States

Location

MeSH Terms

Conditions

Epilepsy, Rolandic; Epilepsy

Interventions

Acoustic Stimulation

Condition Hierarchy (Ancestors)

Epilepsies, Partial; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes

Intervention Hierarchy (Ancestors)

Therapeutics; Sensory Art Therapies; Complementary Therapies; Physical Stimulation; Investigative Techniques

Study Officials

• Catherine Chu, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 24, 2020
• First Posted: September 30, 2020
• Study Start: January 16, 2021
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: 2020 - 2030
• Access Criteria: In accordance with IRB approval

Locations

US (1)