Low-intensity Hippocampal Transcranial Ultrasound Stimulation for Managing Cognitive and Sleep Dysfunction in Preclinical Alzheimer's Disease
NCT ID: NCT07298876
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
20 participants
INTERVENTIONAL
2026-04-01
2027-05-16
Brief Summary
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Objectives: 1) To investigate the safety, feasibility and efficacy of a 2-week focused low-intensity hippocampal TUS on the severity of sleep disturbances and cognitive impairments in elderly patients; 2) to determine the sample size of a full-scale randomized clinical trial of low-intensity TUS in patients with preclinical AD; 3) to evaluate the effects of low-intensity TUS on the severity of sleep quality and cognitive functions at 2, 6 and 10 weeks after the treatments.
Design: A 2-week randomized, double-blind, controlled clinical trial. Methods: Chinese right-handed preclinical AD patients with sleep disturbances (aged from 60 to 90 years) will be randomly assigned to a 2-week intervention of either low intensity TUS or sham TUS, with 10 participants per arm. Before intervention, T1-weighted magnetic resonance imaging (MRI) data is used to construct individual realistic head model. Comprehensive assessments, including sleep quality, cognitive performance and plasma p-tau217, Aß42 and Aß40 will be conducted at baseline, 2nd week, 6th week and 10th week. Program adherence and adverse effects will be monitored throughout intervention.
Detailed Description
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Data analysis: The primary outcomes will be the changes in sleep quality and cognition, and the comparisons of group differences across different time points. Secondary outcomes will be the changes of glymphatic function and neuropathological factors. Intention-to-treat analysis will be carried out. Changes of efficacy indicators from baseline to each follow up point will be tested with mixed effect model.
Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
TRIPLE
Study Groups
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Active TUS
In active TUS group, participants will receive 500 kHz low-intensity TUS.
Low-intensity transcranial ultrasound stimulation
Low-intensity TUS, as an advanced modality of transcranial brain stimulation, enables to stimulate the deep brain structures with optimized focality and specific frequency.
Sham TUS
In sham TUS group, participants will receive sham TUS.
Sham low-intensity transcranial ultrasound stimulation
Sham TUS uses the same settings as the active low-intensity TUS. During the sham treatment, the power will be off.
Interventions
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Low-intensity transcranial ultrasound stimulation
Low-intensity TUS, as an advanced modality of transcranial brain stimulation, enables to stimulate the deep brain structures with optimized focality and specific frequency.
Sham low-intensity transcranial ultrasound stimulation
Sham TUS uses the same settings as the active low-intensity TUS. During the sham treatment, the power will be off.
Eligibility Criteria
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Inclusion Criteria
* Mild neurocognitive disorder due to Alzheimer's disease (NCD-AD) is identified with the Montreal Cognitive Assessment (MoCA) score range from 22 to 26.
* Sleep disturbances or poor sleep quality is assessed and defined with a total score of the Pittsburgh Sleep Quality Index (PSQI) greater than 5.
* No impairments in the activities of daily living.
Exclusion Criteria
* History of neurological diseases including brain tumor, and stroke.
* History of psychiatric disorders including schizophrenia and depression.
* Presence of positive neurological diseases, such as stroke, brain tumor, dementia.
* Physically unable to attend the sessions of intervention.
* Currently enrolled in another intervention study.
* Currently taking a psychiatric or other medication that may affect sleep quality and cognition.
60 Years
85 Years
ALL
No
Sponsors
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The Hong Kong Polytechnic University
OTHER
Chinese University of Hong Kong
OTHER
Responsible Party
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LU Hanna
Assistant Professor
Locations
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Tai Po Hospital
Hong Kong, Tai Po District, Hong Kong
Countries
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Other Identifiers
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2024.652
Identifier Type: -
Identifier Source: org_study_id