NCT04788628

Brief Summary

This study will investigate the role of coordinated brain rhythms during sleep in memory consolidation and determine whether playing precisely timed brief bursts of noise can enhance these rhythms and improve memory in epilepsy inpatients with implanted hippocampal electrodes.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 21, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 25, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 9, 2021

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

November 17, 2025

Status Verified

November 1, 2025

Enrollment Period

5.2 years

First QC Date

February 25, 2021

Last Update Submit

November 14, 2025

Conditions

Epilepsy

Keywords

SleepMemoryAuditory stimulationSpindlesIntracranial monitoringHippocampal ripplesSlow oscillations

Outcome Measures

Primary Outcomes (1)

  • Changes in slow oscillation-spindle-hippocampal ripple coupling

    Changes in the coupling of slow oscillations with spindles and hippocampal ripples during non-Rapid Eye Movement (NREM) sleep as measured by scalp and intracranial EEG between baseline, memory, and auditory stimulation nights.

    Three nights of sleep within three weeks

Secondary Outcomes (4)

  • Changes in sleep-dependent consolidation of motor procedural memory

    Three nights of sleep within three weeks

  • Changes in slow oscillations

    Three nights of sleep within three weeks

  • Changes in sleep spindles

    Three nights of sleep within three weeks

  • Changes in hippocampal ripples

    Three nights of sleep within three weeks

Study Arms (1)

Epilepsy inpatients

EXPERIMENTAL

Epilepsy inpatients with implanted hippocampal electrodes and continuous scalp EEG monitoring

Other: BaselineOther: Motor procedural memory taskOther: Motor procedural memory task plus auditory stimulation

Interventions

BaselineOTHER

Hippocampal and scalp EEG monitoring during overnight sleep

Epilepsy inpatients
Motor procedural memory taskOTHER

Training on the finger tapping MST prior to monitored overnight sleep with MST testing the following morning

Epilepsy inpatients
Motor procedural memory task plus auditory stimulationOTHER

Training on the finger tapping MST prior to monitored overnight sleep that includes auditory stimulation, with MST testing the following morning

Epilepsy inpatients

Eligibility Criteria

Age12 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Inpatients with epilepsy
  • Aged 12-65
  • Undergoing clinically indicated continuous scalp and intracranial EEG monitoring with implanted hippocampal electrodes
  • Fluent in English
  • Able to give informed consent/assent (for minors aged 12-17 or adults with an appointed guardian)

You may not qualify if:

  • Intellectual disability impairing ability to perform task
  • Motor problems that preclude finger tapping task
  • Previous surgery anticipated to disrupt coordination of sleep oscillations in the circuitry of interest

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Epilepsy

Interventions

BaseLine dental cementAcoustic Stimulation

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsSensory Art TherapiesComplementary TherapiesPhysical StimulationInvestigative Techniques

Study Officials

  • Dara Manoach, PhD

    Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 25, 2021

First Posted

March 9, 2021

Study Start

January 21, 2021

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

November 17, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

The PI will disseminate results through presentations at public lectures, scientific institutions and meetings, and/or publications in major journals. The institution and the PI will adhere to the NIH Grants Policy on Sharing of Unique Research Resources including the Sharing of Biomedical Research Resources. Prevailing standards and guidelines in documenting and depositing data sets will be followed. Specifically, quality-controlled data used in publications will be deidentified and made available to requesting scientists, starting one year following the completion of the project. Workflows will be documented and will allow any external groups to reproduce results from the raw data. The PI will be responsible for overseeing the sharing the data. Raw and summary data will be submitted to the appropriate NIMH Data Archive annually, including The National Database for Clinical Trials Related to Mental Illness (NDCT).

Time Frame
Data will be available one year following the completion of the project.

Locations

US(1)