Sleep Spindles and Memory in Rolandic Epilepsy

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04569708
• Other study ID #: 2020P002668
• Secondary ID: 1R01NS115868-01
• Status: Recruiting
• Phase: N/A
• Start date: January 16, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2023
• Source: Massachusetts General Hospital
• Contact: Catherine Chu, MD
• Phone: 617-726-6540
• Email: cjchu[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Auditory stimulation
Quiet auditory stimulation timed with sleep physiology

Locations

Country	Name	City	State
United States	Athinoula A. Martinos Center Biomedical Imaging	Charlestown	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Boston University, National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Spindle-slow oscillation coupling	Cross frequency coupling	1-5 hours
Primary	Spindle Density	Spindle count per minute during non-rapid eye movement (NREM) sleep	1-5 hours
Primary	Memory performance	Percent improvement in memory task performance	1-5 hours