Auditory Stimulation Effects on Sleep and Memory in Patients With Epilepsy
Primary Purpose
Epilepsy
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Baseline
Motor procedural memory task
Motor procedural memory task plus auditory stimulation
Sponsored by
About this trial
This is an interventional basic science trial for Epilepsy focused on measuring Sleep, Memory, Auditory stimulation, Spindles, Intracranial monitoring, Hippocampal ripples, Slow oscillations
Eligibility Criteria
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
Sites / Locations
- Massachusetts General HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Epilepsy inpatients
Arm Description
Epilepsy inpatients with implanted hippocampal electrodes and continuous scalp EEG monitoring
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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
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
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
Full Information
NCT ID
NCT04788628
First Posted
February 25, 2021
Last Updated
January 24, 2023
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04788628
Brief Title
Auditory Stimulation Effects on Sleep and Memory in Patients With Epilepsy
Official Title
Effects of Auditory Stimulation on Coordinated Non-REM Sleep Oscillations and Memory in Epilepsy Inpatients With Implanted Hippocampal Electrodes
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
March 31, 2026 (Anticipated)
Study Completion Date
March 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Sleep, Memory, Auditory stimulation, Spindles, Intracranial monitoring, Hippocampal ripples, Slow oscillations
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Epilepsy inpatients
Arm Type
Experimental
Arm Description
Epilepsy inpatients with implanted hippocampal electrodes and continuous scalp EEG monitoring
Intervention Type
Other
Intervention Name(s)
Baseline
Intervention Description
Hippocampal and scalp EEG monitoring during overnight sleep
Intervention Type
Other
Intervention Name(s)
Motor procedural memory task
Intervention Description
Training on the finger tapping MST prior to monitored overnight sleep with MST testing the following morning
Intervention Type
Other
Intervention Name(s)
Motor procedural memory task plus auditory stimulation
Intervention Description
Training on the finger tapping MST prior to monitored overnight sleep that includes auditory stimulation, with MST testing the following morning
Primary Outcome Measure Information:
Title
Changes in slow oscillation-spindle-hippocampal ripple coupling
Description
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.
Time Frame
Three nights of sleep within three weeks
Secondary Outcome Measure Information:
Title
Changes in sleep-dependent consolidation of motor procedural memory
Description
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.
Time Frame
Three nights of sleep within three weeks
Title
Changes in slow oscillations
Description
Changes in slow oscillations during non-rapid eye movement (NREM) sleep as measured by EEG between the baseline, memory, and auditory stimulation nights
Time Frame
Three nights of sleep within three weeks
Title
Changes in sleep spindles
Description
Changes in sleep spindles during non-rapid eye movement (NREM) sleep as measured by EEG between baseline, memory, and auditory stimulation nights
Time Frame
Three nights of sleep within three weeks
Title
Changes in hippocampal ripples
Description
Changes in hippocampal ripples during non-rapid eye movement (NREM) sleep as measured by intracranial EEG between baseline, memory, and auditory stimulation nights
Time Frame
Three nights of sleep within three weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dara Manoach, PhD
Phone
617-724-6148
Email
dara.manoach@mgh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dara Manoach, PhD
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dara Manoach, PhD
Phone
617-724-6148
Email
dara.manoach@mgh.harvard.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Auditory Stimulation Effects on Sleep and Memory in Patients With Epilepsy
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