Memory, DelayedNCT05452122
Decoding and Selective Modulation of Human Memory During Awake/Sleep Cycles
A study testing Auditory and Electrical Stimulation in people with Memory, Delayed, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The proposed project seeks to elucidate memory processes and consolidation during sleep by leveraging the unique capability of direct recordings from the human brain at multiple levels of resolution-single neurons, localized neuronal assemblies, intracranial local field potentials-during rich behavioral tasks with… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Memory, Delayed
- What is being tested?
- Auditory and Electrical Stimulation
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2022to 31 Aug 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All epilepsy patients between the ages of 18 and 65 who undergo depth electrode placement for clinical purposes
- Eligibility is determined by the epilepsy surgery team (based on neuropsychological testing and on psychiatric evaluation)
- Willing to provide informed consent and participate the study
Who cannot join
- Neurological or psychiatric issues, other than epilepsy, that would put the patient at risk
- Patient is younger than 18 or older than 65 years of age
- Unwilling to provide informed consent
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, 1 recruiting
- Recruiting
University of California Los Angeles
Los Angeles, California, 90095
Andreina Hampton, 3236105293, amhampton@mednet.ucla.edu
About this study
The proposed project seeks to elucidate memory processes and consolidation during sleep by leveraging the unique capability of direct recordings from the human brain at multiple levels of resolution-single neurons, localized neuronal assemblies, intracranial local field potentials-during rich behavioral tasks with real-life narratives and extracting neural features that relate to different aspects of episodic experience. The investigators will further probe causal mechanisms of consolidation by application of auditory and electrical stimulations during sleep and its effect on modulating memory processes.
- Conditions
- Memory, Delayed
- Being tested
- Auditory and Electrical Stimulation
- Keywords
- sleep, stimulation, memory, learning, single-unit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auditory and Electrical StimulationOther
Electrical and auditory stimulation will be applied during sleep.
What is being measured
The primary outcome is the main question the study is designed to answer.
Recognition Accuracy
Accuracy will be analyzed to evaluate performance on memory tasks before and after sleep, specifically the ability to recognize correct items compared to all items. Accuracy will be measured using the sum of true positive and true negative divided by the total number of items. A within-subjects design will be employed and accuracy for stimulated vs. non-stimulated items will be compared.
Measured: 1-2 days contained within the participants' 1-2 week hospital stay; Specifically for each experiment, the outcome measure will be computed during the pre- and post-sleep memory tasks
Recognition Discriminability (D-prime)
Discriminability will be analyzed to evaluate performance on memory tasks before and after sleep, specifically the ability to recognize target items from distractor items. Discriminability will be measured using a discriminability index (d-prime). In addition to d-prime being a normalized metric, it provides critical and complementary information to the accuracy metric (Outcome 1) given that it is a measure of sensitivity (and not bias) in the cases where data labels are not balanced . A within-subjects design will be employed and discriminability for stimulated vs. non-stimulated items will be compared.
Measured: 1-2 days contained within the participants' 1-2 week hospital stay; Specifically for each experiment, the outcome measure will be computed during the pre- and post-sleep memory tasks.
Secondary outcomes (2)
Power sleep oscillations
The power of slow waves, spindles, ripples (all in units of dbm) will be computed. Employing a within-subjects design, the investigators will compare the change in the power of these oscillatory features for stimulated vs. non-stimulated items.
Measured: 1-2 days contained within the participants' 1-2 week hospital stay. Specifically for each experiment, the outcome measure will be computed during the sleep period between pre and post-sleep memory tasks.
Neuronal replay index
Neuronal replay index, defined as the percentage of time during which neurons manifest replay-like activation as compared to the duration of deep sleep will be computed. Employing a within-subjects design, the investigators will compare the replay measure for stimulated vs. non-stimulated items.
Measured: 1-2 days contained within the participants' 1-2 week hospital stay. Specifically for each experiment, the outcome measure will be computed during the sleep period between pre and post-sleep memory tasks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start13 Jul 2022
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Memory, DelayedStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Itzhak Fried, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05452122
- Sponsor's protocol ID
- U01NS123128
- Other IDs
- 1U01NS123128-01
- Status last verified
- Oct 2025
- First submitted
- 18 Jun 2022
- Last updated
- 14 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will make data available in accordance with the latest BRAIN Initiative Data Sharing Plan. The data consists of intracranial recordings from human epilepsy patients while participants perform a cognitive task during awake periods and follow-up recordings during overnight sleep or nap sessions. These datasets will be shared in a HIPAA-compliant manner (anonymized and coded) and will not include any sensitive information such as Protected Health Information. The investigators plan to deposit the data using the NIH Data Archive Brain Initiative platform, specialized at storage and organization of invasive neurophysiology data.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decoding and Selective Modulation of Human Memory During Awake/Sleep Cycles
- ClinicalTrials.gov ID
- NCT05452122
- Acronym / sponsor ID
- U01NS123128
- Conditions
- Memory, Delayed
- Keywords
- sleep, stimulation, memory, learning, single-unit
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- University of Iowa, National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 13 Jul 2022 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 11 Jul 2022 (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.
The proposed project seeks to elucidate memory processes and consolidation during sleep by leveraging the unique capability of direct recordings from the human brain at multiple levels of resolution-single neurons, localized neuronal assemblies, intracranial local field potentials-during rich behavioral tasks with real-life narratives and extracting neural features that relate to different aspects of episodic experience. The investigators will further probe causal mechanisms of consolidation by application of auditory and electrical stimulations during sleep and its effect on modulating memory processes.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All epilepsy patients between the ages of 18 and 65 who undergo depth electrode placement for clinical purposes
- Eligibility is determined by the epilepsy surgery team (based on neuropsychological testing and on psychiatric evaluation)
- Willing to provide informed consent and participate the study
Key exclusion criteria (3 listed)
- Neurological or psychiatric issues, other than epilepsy, that would put the patient at risk
- Patient is younger than 18 or older than 65 years of age
- Unwilling to provide informed consent
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 |
|---|---|---|
| Auditory and Electrical StimulationElectrical and auditory stimulation will be applied during sleep. | Other | – |
Primary outcome
Recognition Accuracy
Time frame: 1-2 days contained within the participants' 1-2 week hospital stay; Specifically for each experiment, the outcome measure will be computed during the pre- and post-sleep memory tasks
Accuracy will be analyzed to evaluate performance on memory tasks before and after sleep, specifically the ability to recognize correct items compared to all items. Accuracy will be measured using the sum of true positive and true negative divided by the total number of items. A within-subjects design will be employed and accuracy for stimulated vs. non-stimulated items will be compared.
Recognition Discriminability (D-prime)
Time frame: 1-2 days contained within the participants' 1-2 week hospital stay; Specifically for each experiment, the outcome measure will be computed during the pre- and post-sleep memory tasks.
Discriminability will be analyzed to evaluate performance on memory tasks before and after sleep, specifically the ability to recognize target items from distractor items. Discriminability will be measured using a discriminability index (d-prime). In addition to d-prime being a normalized metric, it provides critical and complementary information to the accuracy metric (Outcome 1) given that it is a measure of sensitivity (and not bias) in the cases where data labels are not balanced . A within-subjects design will be employed and discriminability for stimulated vs. non-stimulated items will be compared.
2 secondary outcomes
Power sleep oscillations
Time frame: 1-2 days contained within the participants' 1-2 week hospital stay. Specifically for each experiment, the outcome measure will be computed during the sleep period between pre and post-sleep memory tasks.
Neuronal replay index
Time frame: 1-2 days contained within the participants' 1-2 week hospital stay. Specifically for each experiment, the outcome measure will be computed during the sleep period between pre and post-sleep memory tasks.
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 14 Oct 2025.
- Individual participant dataSharing planned: Yes. The investigators will make data available in accordance with the latest BRAIN Initiative Data Sharing Plan. The data consists of intracranial recordings from human epilepsy patients while participants perform a cognitive task during awake periods and follow-up recordings during overnight sleep or nap sessions. These datasets will be shared in a HIPAA-compliant manner (anonymized and coded) and will not include any sensitive information such as Protected Health Information. The investigators plan to deposit the data using the NIH Data Archive Brain Initiative platform, specialized at storage and organization of invasive neurophysiology data.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auditory and Electrical Stimulation in people with Memory, Delayed, run by University of California, Los Angeles 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 3 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: looking for participants now, as of the sponsor's last update on 14 Oct 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?
Contact Andreina Hampton (3236105293, amhampton@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recognition Accuracy (time frame: 1-2 days contained within the participants' 1-2 week hospital stay; Specifically for each experiment, the outcome measure will be computed during the pre- and post-sleep memory tasks). The study lists 2 primary outcomes in all. 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 14 Oct 2025.