Auditory Stimulation Effects on Sleep and Memory in Patients With Epilepsy

Effects of Auditory Stimulation on Coordinated Non-REM Sleep Oscillations and Memory in Epilepsy Inpatients With Implanted Hippocampal Electrodes

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Epilepsy
• Intervention / Treatment: Other: Baseline; Other: Motor procedural memory task; Other: Motor procedural memory task plus auditory stimulation

Detailed Description

The investigators will test the hypotheses that coordinated brain rhythms during nonrapid eye movement sleep are associated with memory consolidation and can be enhanced with auditory stimulation (playing precisely timed brief bursts of quiet noise) to improve memory. The investigators will measure differences in sleep and memory performance in epilepsy inpatients with implanted hippocampal electrodes and continuous full scalp EEG monitoring under three overnight sleep conditions: a baseline night; a memory night during which sleep-dependent memory consolidation is assessed with the finger tapping motor sequence task (MST) with training prior to sleep and testing the next morning; and a stimulation night during which participants train on the MST, have precisely timed auditory stimulation during the sleep that follows, and are tested on the MST in the morning.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Epilepsy inpatients; Epilepsy inpatients with implanted hippocampal electrodes and continuous scalp EEG monitoring

Other: Baseline; Hippocampal and scalp EEG monitoring during overnight sleep; Other: Motor procedural memory task; Training on the finger tapping MST prior to monitored overnight sleep with MST testing the following morning; Other: Motor procedural memory task plus auditory stimulation; Training on the finger tapping MST prior to monitored overnight sleep that includes auditory stimulation, with MST testing the following morning

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in sleep-dependent consolidation of motor procedural memory	Changes in sleep-dependent improvement of motor procedural memory performance on the finger tapping motor sequence task (MST) between baseline, memory, and auditory stimulation nights. Different sequences are employed for the memory and auditory stimulation nights in a counter-balanced order.	Three nights of sleep within three weeks
Changes in slow oscillations	Changes in slow oscillations during non-rapid eye movement (NREM) sleep as measured by EEG between the baseline, memory, and auditory stimulation nights	Three nights of sleep within three weeks
Changes in sleep spindles	Changes in sleep spindles during non-rapid eye movement (NREM) sleep as measured by EEG between baseline, memory, and auditory stimulation nights	Three nights of sleep within three weeks
Changes in hippocampal ripples	Changes in hippocampal ripples during non-rapid eye movement (NREM) sleep as measured by intracranial EEG between baseline, memory, and auditory stimulation nights	Three nights of sleep within three weeks

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Dara Manoach, PhD, Professor

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2021
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: February 25, 2021
• First Submitted That Met QC Criteria: March 8, 2021
• First Posted (Actual): March 9, 2021

Study Record Updates

• Last Update Posted (Estimated): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Sleep; Memory; Auditory stimulation; Spindles; Intracranial monitoring; Hippocampal ripples; Slow oscillations
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Investigative Techniques; Therapeutics; Complementary Therapies; Sensory Art Therapies; Physical Stimulation; Acoustic Stimulation; BaseLine dental cement
• Other Study ID Numbers: 2020P003959

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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).
• IPD Sharing Time Frame: Data will be available one year following the completion of the project.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No