Rolandic EpilepsyNCT04569708
Sleep Spindles and Memory in Rolandic Epilepsy
A study testing Closed loop auditory stimulation in people with Rolandic Epilepsy and Rolandic Epilepsy, Benign, run by Massachusetts General Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 4 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Rolandic Epilepsy, Rolandic Epilepsy, Benign, Centrotemporal Epilepsy
- What is being tested?
- Closed loop auditory stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2021to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Clinical diagnosis of childhood epilepsy with centrotemporal spikes (CECTS)or Rolandic epilepsy by child neurologist
- Ages 4-18 years
- Has an EEG with sleep activated centrotemporal spikes
- Has had at least 1 focal motor or generalized seizure
Who cannot join
- Has abnormal brain MRI
- Has other unrelated neurological disease
- Unable to have an MRI/MEG due to claustrophobia, history of frequent vomiting, permanent metal in body (braces), or over MRI weight limit: 350lbs
Trial locations and contacts
1 site in 1 country.
United States1 site
Athinoula A. Martinos Center Biomedical Imaging
Charlestown, Massachusetts, 02129
About this study
Official title: Auditory Stimulation Effect on Spindles and Sleep Dependent Learning in Rolandic Epilepsy
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.
Read the 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.
- Conditions
- Rolandic Epilepsy, Rolandic Epilepsy, Benign, Centrotemporal Epilepsy, Centrotemporal; EEG Spikes, Epilepsy of Childhood, Epilepsy; Seizure, Epilepsy
- Being tested
- Closed loop auditory stimulation
- Medical subject headings
- Epilepsy, Rolandic, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed loop auditory stimulationOther
Quiet auditory stimulation timed with sleep physiology
| Study group | Role | What they receive |
|---|---|---|
| Closed loop auditory stimulation Children and adolescents with epilepsy and controls | Experimental | Closed loop auditory stimulation during nap Receives: Other: Closed loop auditory stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spindle Density
Spindle count per minute during non-rapid eye movement (NREM) sleep
Measured: 1-5 hours
Memory performance
Percent improvement in memory task performance
Measured: 1-5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start16 Jan 2021
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Why it stopped: Subjects were never enrolled and PI moved
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rolandic EpilepsyStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Boston University, National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Principal investigator, Catherine Chu, MD, Massachusetts General Hospital
- Investigators
- Catherine Chu, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04569708
- Sponsor's protocol ID
- 2020P002668
- Other IDs
- 1R01NS115868-01
- Status last verified
- Aug 2026
- First submitted
- 24 Sep 2020
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Derivative data will be shared with appropriate IRB approval per publication requirements
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auditory Stimulation Effect on Spindles and Sleep Dependent Learning in Rolandic Epilepsy
- ClinicalTrials.gov ID
- NCT04569708
- Acronym / sponsor ID
- 2020P002668
- Conditions
- Rolandic Epilepsy, Rolandic Epilepsy, Benign, Centrotemporal Epilepsy, Centrotemporal; EEG Spikes, Epilepsy of Childhood, Epilepsy; Seizure, Epilepsy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Subjects were never enrolled and PI moved
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Boston University, National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 16 Jan 2021 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 30 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Closed loop auditory stimulation Children and adolescents with epilepsy and controls | Experimental | Other: Closed loop auditory stimulationClosed loop auditory stimulation during nap |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of childhood epilepsy with centrotemporal spikes (CECTS)or Rolandic epilepsy by child neurologist
- Ages 4-18 years
- Has an EEG with sleep activated centrotemporal spikes
- Has had at least 1 focal motor or generalized seizure
Key exclusion criteria (3 listed)
- Has abnormal brain MRI
- Has other unrelated neurological disease
- Unable to have an MRI/MEG due to claustrophobia, history of frequent vomiting, permanent metal in body (braces), or over MRI weight limit: 350lbs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Closed loop auditory stimulationQuiet auditory stimulation timed with sleep physiology | Other | Closed loop auditory stimulation Children and adolescents with epilepsy and controls |
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: Yes. Derivative data will be shared with appropriate IRB approval per publication requirements
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Chu, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closed loop auditory stimulation in people with Rolandic Epilepsy and Rolandic Epilepsy, Benign, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spindle Density (time frame: 1-5 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.