Sleep Spindles and Memory in Rolandic Epilepsy

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04569708
• Collaborator: Boston University (Other), National Institute of Neurological Disorders and Stroke (NINDS) (NIH)
• Enrollment: 100
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 59.5
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rolandic Epilepsy; Rolandic Epilepsy, Benign; Centrotemporal Epilepsy; Centrotemporal; EEG Spikes, Epilepsy of Childhood; Epilepsy; Seizure; Epilepsy	Other: Auditory stimulation	N/A

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

1. 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 Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Auditory Stimulation Effect on Spindles and Sleep Dependent Learning in Rolandic Epilepsy
• Actual Study Start Date: Jan 16, 2021
• Anticipated Primary Completion Date: Dec 31, 2025
• Anticipated Study Completion Date: Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Children and adolescents with epilepsy and controls Closed loop auditory stimulation during nap	Other: Auditory stimulation; Quiet auditory stimulation timed with sleep physiology

Outcome Measures

Primary Outcome Measures

1. Spindle Density [1-5 hours]

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

2. Memory performance [1-5 hours]

   Percent improvement in memory task performance

Other Outcome Measures

1. Spindle-slow oscillation coupling [1-5 hours]

   Cross frequency coupling

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts 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

4. Claustrophobic

5. History of frequent vomiting

6. Permanent metal in body, braces

7. Over MRI weight limit: 350lbs

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Athinoula A. Martinos Center Biomedical Imaging	Charlestown	Massachusetts	United States	02129

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Catherine Chu, MD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Catherine Chu, MD, Principal Investigator, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT04569708
• Other Study ID Numbers: 2020P002668; 1R01NS115868-01
• First Posted: Sep 30, 2020
• Last Update Posted: Apr 11, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Epilepsy; Seizures; Epilepsy, Rolandic

Study Results

No Results Posted as of Apr 11, 2022