Sleep Spindles and Memory in Rolandic Epilepsy | NCT04569708

Studies
Sleep Spindles and Memory in Rolandic Epilepsy

NCT04569708

Sponsor

Massachusetts General Hospital

Status

Withdrawn

Last Update Posted

Jun 30, 2026Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

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

Interventions

Closed loop auditory stimulation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1R01NS115868-01	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Subjects were never enrolled and PI moved

Expanded Access Info

Start Date

Jan 16, 2021Actual

Primary Completion Date

Jun 30, 2025Actual

Completion Date

Jun 30, 2025Actual

First Submitted Date

Sep 24, 2020

First Submission Date that Met QC Criteria

Sep 24, 2020

First Posted Date

Sep 30, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 28, 2026

Last Update Posted Date

Jun 30, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Catherine Chu, MD, Principal Investigator, Massachusetts General HospitalPrincipal Investigator

Lead Sponsor

Massachusetts General HospitalOTHER

Collaborators

Name	Class
Boston University	OTHER
National Institute of Neurological Disorders and Stroke (NINDS)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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, or a sham. The auditory stimulus will be calibrated in volume to not cause arousals. After napping, subjects will undergo cognitive testing and memory task testing.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Closed loop auditory stimulation Children and adolescents with epilepsy and controls	Experimental	Closed loop auditory stimulation during nap	Other: Closed loop auditory stimulation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Closed loop auditory stimulation	Other	Quiet auditory stimulation timed with sleep physiology	Closed loop auditory stimulation Children and adolescents with epilepsy and controls

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

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

Eligibility Module

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 spikes4.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
1. Claustrophobic
2. History of frequent vomiting
3. Permanentmetalinbody,braces
4. Over MRI weight limit: 350lbs

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Catherine Chu, MD	Massachusetts General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Athinoula A. Martinos Center Biomedical Imaging		Charlestown	Massachusetts	02129	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Derivative data will be shared with appropriate IRB approval per publication requirements

Types

Analytic Code

Time Frame

2020 - 2030

Access Criteria

In accordance with IRB approval

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D019305	Epilepsy, Rolandic
D004827	Epilepsy

Ancestor Terms

ID	Term
D004828	Epilepsies, Partial
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided