Skip to main content
Clinical Trials/NCT04569708
NCT04569708
Recruiting
N/A

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

Massachusetts General Hospital1 site in 1 country100 target enrollmentJanuary 16, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Rolandic Epilepsy
Sponsor
Massachusetts General Hospital
Enrollment
100
Locations
1
Primary Endpoint
Spindle Density
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 16, 2021
End Date
December 31, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Catherine Chu, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Spindle Density

Time Frame: 1-5 hours

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

Memory performance

Time Frame: 1-5 hours

Percent improvement in memory task performance

Study Sites (1)

Loading locations...

Similar Trials