NCT07042633

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
20mo left

Started Mar 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress57%
Mar 2024Dec 2027

Study Start

First participant enrolled

March 7, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 29, 2025

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

June 29, 2025

Status Verified

June 1, 2025

Enrollment Period

3.8 years

First QC Date

May 20, 2025

Last Update Submit

June 26, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Overall cognitive function

    Mini-Mental State Examination (MMSE) and the Montreal Cognitive Assessment (MOCA) scale scores.

    baseline and one-year follow-up

Secondary Outcomes (5)

  • Attention and executive functions

    Baseline and follow up

  • Language function

    Baseline and one-year follow up

  • Memory function

    Baseline and one-year follow up

  • Brain imaging data

    baseline and one-year follow-up

  • Electroencephalogram (EEG) data.

    baseline and one-year follow-up

Eligibility Criteria

Age55 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Elderly population

You may qualify if:

  • \- 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, 100053, China

RECRUITING

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2025

First Posted

June 29, 2025

Study Start

March 7, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

June 29, 2025

Record last verified: 2025-06

Locations