Mechanism of Gamma Oscillation Synchronization in the Prefrontal-hippocampal Circuit for Memory Dysfunction in Patients With White Matter Lesions of Cerebral Small Vessel Disease

June 26, 2025 updated by: Xuanwu Hospital, Beijing
The mechanism underlying memory impairment caused by white matter lesions of cerebral small vessel disease is still unclear. The disrupted synchronization of gamma oscillations in the prefrontal-hippocampal circuit is a potential key mechanism. Our study has demonstrated that white matter lesions lead to demyelination of the connection tracts between the prefrontal lobe and hippocampus, which is closely related to memory dysfunction. However, further studies are required to explore if these microstructural changes in white matter tracts influence memory function by affecting gamma oscillations. Thus, this project will use the previously established episodic memory task and event-related potential to determine the changes in gamma oscillations in the prefrontal-hippocampal circuit and the effects on memory encoding and retrieval. Combining multimodal imaging, we will explore the mediating role of white matter microstructure damage, and establish a machine learning prediction model for memory impairment. In addition, transcranial alternation current stimulation (tACS) will be used to investigate the mechanisms of memory improvement by regulating the prefrontal-hippocampal gamma oscillations. This project will clarify the neural oscillation mechanism underlying memory impairment caused by white matter lesions of cerebral small vessel disease, with the expectation of providing new predictive indicators and interventions.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100053
        • Recruiting
        • Xuanwu Hospital Capital Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Elderly population

Description

Inclusion Criteria:

  • - Individuals with cerebral small vessel disease, normal cognition or mild cognitive impairment subjects;
  • Participants with complete demographic data, neuropsychiatric scale assessments, imaging data, and EEG data.

Exclusion Criteria:

  • Severe aphasia, physical disability, or other conditions preventing completion of neuropsychological assessments;
  • History of cerebrovascular stroke with documented neurological deficits during onset and corresponding lesions on neuroimaging;
  • Neurological disorders that may cause cognitive impairment, including alcohol abuse, drug addiction, traumatic brain injury, epilepsy, encephalitis, or normal-pressure hydrocephalus;
  • Systemic diseases potentially contributing to mild cognitive impairment (e.g., hepatic/renal insufficiency, endocrine disorders, vitamin deficiencies);
  • Current diagnosis of major depressive disorder or psychiatric disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall cognitive function
Time Frame: baseline and one-year follow-up
Mini-Mental State Examination (MMSE) and the Montreal Cognitive Assessment (MOCA) scale scores.
baseline and one-year follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Attention and executive functions
Time Frame: Baseline and follow up
the scores are evaluated using the Clock Drawing Test (CDT), the Digit Span Test (DST), and the Trail Making Test (TMT).
Baseline and follow up
Language function
Time Frame: Baseline and one-year follow up
Boston Naming Test (BNT)
Baseline and one-year follow up
Memory function
Time Frame: Baseline and one-year follow up
Digit Span Test (DST) and the WHO-UCLA Auditory Verbal Learning Test (AVLT).
Baseline and one-year follow up
Brain imaging data
Time Frame: baseline and one-year follow-up

Based on DTI data, the following metrics can be extracted:

Fractional Anisotropy (FA) Mean Diffusivity (MD) Axial Diffusivity (AD) Radial Diffusivity (RD)
baseline and one-year follow-up
Electroencephalogram (EEG) data.
Time Frame: baseline and one-year follow-up

Based on EEG data, time-frequency analysis and cross-frequency coupling analysis can be performed to extract the following metrics:

Theta Band Neural Oscillation Energy Theta-Gamma Coupling Strength
baseline and one-year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xuanwu Hospital, Beijing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 7, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 20, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NO.2024092

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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