EpilepsyNCT04788628
Auditory Stimulation Effects on Sleep and Memory in Patients With Epilepsy
A study testing Baseline, Motor procedural memory task and Motor procedural memory task plus auditory stimulation in people with Epilepsy, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Baseline, Motor procedural memory task and Motor procedural memory task plus auditory stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2021to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: 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.
Read the 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.
- Conditions
- Epilepsy
- Being tested
- Baseline, Motor procedural memory task, Motor procedural memory task plus auditory stimulation
- Keywords
- Sleep, Memory, Auditory stimulation, Spindles, Intracranial monitoring, Hippocampal ripples, Slow oscillations
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaselineOther
Hippocampal and scalp EEG monitoring during overnight sleep
Motor procedural memory taskOther
Training on the finger tapping MST prior to monitored overnight sleep with MST testing the following morning
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
| Study group | Role | What they receive |
|---|---|---|
| Epilepsy inpatients | Experimental | Epilepsy inpatients with implanted hippocampal electrodes and continuous scalp EEG monitoring Receives: Other: Baseline; Other: Motor procedural memory task; Other: Motor procedural memory task plus auditory stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Three nights of sleep within three weeks
Secondary outcomes (4)
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.
Measured: 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
Measured: 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
Measured: 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
Measured: Three nights of sleep within three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start21 Jan 2021
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dara S. Manoach, PhD, Massachusetts General Hospital
- Investigators
- Dara Manoach, PhD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04788628
- Sponsor's protocol ID
- 2020P003959
- Status last verified
- Nov 2025
- First submitted
- 25 Feb 2021
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Auditory Stimulation on Coordinated Non-REM Sleep Oscillations and Memory in Epilepsy Inpatients With Implanted Hippocampal Electrodes
- ClinicalTrials.gov ID
- NCT04788628
- Acronym / sponsor ID
- 2020P003959
- Conditions
- Epilepsy
- Keywords
- Sleep, Memory, Auditory stimulation, Spindles, Intracranial monitoring, Hippocampal ripples, Slow oscillations
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 9 Mar 2021 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epilepsy inpatients | Experimental | Other: Baseline, Other: Motor procedural memory task, Other: Motor procedural memory task plus auditory stimulationEpilepsy inpatients with implanted hippocampal electrodes and continuous scalp EEG monitoring |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| BaselineHippocampal and scalp EEG monitoring during overnight sleep | Other | Epilepsy inpatients |
| Motor procedural memory taskTraining on the finger tapping MST prior to monitored overnight sleep with MST testing the following morning | Other | Epilepsy inpatients |
| Motor procedural memory task plus auditory stimulationTraining on the finger tapping MST prior to monitored overnight sleep that includes auditory stimulation, with MST testing the following morning | Other | Epilepsy inpatients |
Primary outcome
Changes in slow oscillation-spindle-hippocampal ripple coupling
Time frame: Three nights of sleep within three weeks
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.
4 secondary outcomes
Changes in sleep-dependent consolidation of motor procedural memory
Time frame: Three nights of sleep within three weeks
Changes in slow oscillations
Time frame: Three nights of sleep within three weeks
Changes in sleep spindles
Time frame: Three nights of sleep within three weeks
Changes in hippocampal ripples
Time frame: Three nights of sleep within three weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Individual participant dataSharing planned: Yes. 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).
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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.
Dara Manoach, PhD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baseline, Motor procedural memory task and Motor procedural memory task plus auditory stimulation in people with Epilepsy, 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 5 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: enrolling by invitation, as of the sponsor's last update on 17 Nov 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Changes in slow oscillation-spindle-hippocampal ripple coupling (time frame: Three nights of sleep within three weeks). 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 17 Nov 2025.