deltatrials
Completed INTERVENTIONAL NCT04569708

Sleep Spindles and Memory in Rolandic Epilepsy

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

Sponsor: Boston University

Updated 9 times since 2020 Last updated: Apr 26, 2026 Started: Jan 16, 2021 Primary completion: Jun 30, 2025 Completion: Jun 30, 2025
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This observational or N/A phase trial investigates Centrotemporal Epilepsy and Centrotemporal; EEG Spikes, Epilepsy of Childhood and is currently completed. Boston University leads this study, which shows 9 recorded versions since 2021 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Study Description(click to expand)

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.

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.

Status Flow

~Oct 2020 – ~Jan 2021 · 3 months · monthly snapshot~Jan 2021 – ~Mar 2021 · 59 days · monthly snapshot~Mar 2021 – ~May 2022 · 14 months · monthly snapshotRecruiting~May 2022 – ~Jul 2023 · 14 months · monthly snapshotRecruiting~Jul 2023 – ~Jul 2024 · 12 months · monthly snapshotRecruiting~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Dec 2024 · 3 months · monthly snapshot~Dec 2024 – ~May 2026 · 17 months · monthly snapshotRecruitingMay 4, 2026 – present · 4 months · daily API

Change History

9 versions recorded
  1. May 4, 2026 — Present [daily]

    Completed

    Status: RecruitingCompleted · Phase: NANone

  2. Dec 2024 — May 2026 [monthly]

    Recruiting NA

  3. Sep 2024 — Dec 2024 [monthly]

    Recruiting NA

  4. Jul 2024 — Sep 2024 [monthly]

    Recruiting NA

  5. Jul 2023 — Jul 2024 [monthly]

    Recruiting NA

Show 4 earlier versions
  1. May 2022 — Jul 2023 [monthly]

    Recruiting NA

  2. Mar 2021 — May 2022 [monthly]

    Recruiting NA

    Status: Not Yet RecruitingRecruiting

  3. Jan 2021 — Mar 2021 [monthly]

    Not Yet Recruiting NA

  4. Oct 2020 — Jan 2021 [monthly]

    Not Yet Recruiting NA

    First recorded

Eligibility 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.

Contact Information

Sponsor contact:
  • Boston University
  • Massachusetts General Hospital
  • National Institute of Neurological Disorders and Stroke (NINDS)
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations