Sleep Spindles and Memory in Rolandic Epilepsy

Not Applicable

Recruiting

• Conditions: Centrotemporal; EEG Spikes, Epilepsy of Childhood; Centrotemporal Epilepsy; Rolandic Epilepsy, Benign; Epilepsy; Seizure; Epilepsy; Rolandic Epilepsy
• Interventions: Other: Auditory stimulation

• Registration Number: NCT04569708
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study First Submitted: 2020-09-24
• Study First Submitted QC: 2020-09-24
• Study First Posted: 2020-09-30
• Study Start: 2021-01-16
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-20
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Children and adolescents with epilepsy and controls	Auditory stimulation	Closed loop auditory stimulation during nap

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Athinoula A. Martinos Center Biomedical Imaging; 🇺🇸 Charlestown, Massachusetts, United States