Sleep Spindles and Memory in Rolandic Epilepsy

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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04569708

Enrollment

100

Registered

2020-09-30

Start date

2021-01-16

Completion date

2025-12-31

Last updated

2024-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERAuditory stimulation

Quiet auditory stimulation timed with sleep physiology

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

4 Years to 18 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Spindle Density	1-5 hours	Spindle count per minute during non-rapid eye movement (NREM) sleep
Memory performance	1-5 hours	Percent improvement in memory task performance

Other

Measure	Time frame	Description
Spindle-slow oscillation coupling	1-5 hours	Cross frequency coupling

Countries

United States

Contacts

Primary ContactCatherine Chu, MD

cjchu@mgh.harvard.edu617-726-6540

Backup ContactErin Berja, BS

eberja@mgh.harvard.edu631-317-0413

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026