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临床试验/NCT07433738
NCT07433738尚未招募不适用

Personalized Assessment of High-definition Slow-oscillatory Transcranial Direct Current Stimulation (So-tDCS) in Older Adults With Subjective Cognitive and Sleep Complaints

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年5月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
试验地点
1
主要终点
Impedance

研究概览

简要总结

Background: Subjective cognitive decline (SCD) is considered to be the early risk stage of dementia. Untreated SCD comorbid with sleep disturbances may accelerate the progression of neurodegeneration (β-amyloid and tau) and lead to cognitive deficits. At present, non-pharmacological interventions for managing SCD and sleep disturbances are very limited. High-definition slow-oscillatory transcranial direct current stimulation (so-tDCS) is a newly developed frequency-specific modality of brain stimulation for promoting brain health and cognition. Notably, neurophysiological feature (impedance) during tDCS was found to be related to treatment outcomes and adverse effects (skin injury). Objectives: We propose to 1) develop a high-performing neurophysiological signal detector for tDCS and test its feasibility and flexibility in a randomized clinical trial; 2) investigate the short-term and long-term effects of high-definition so-tDCS on SCD, sleep quality and plasma Aβ and p-tau levels; 3) examine the values of neurophysiological signals in predicting the treatment outcomes at individual level. Design: A randomized, double-blind, sham-controlled trial. Methods: Chinese right-handed older adults with SCD and sleep disturbances will be randomly assigned to a 4-week intervention of either high-definition 0.75 Hz so-tDCS or sham tDCS, with 40 participants per arm. Pre-treatment magnetic resonance imaging (MRI) scans will be collected to exclude the cases with major neurological disease and quantify individual's brain features. Galvanic skin response, subjective cognitive complaints, sleep quality, plasma p-tau and β-amyloid levels and domain-specific cognition will be assessed at baseline, 4th week, 8th week and 12th week. Program adherence and adverse effects will be monitored throughout the whole intervention.

详细描述

This study aims to investigate the efficacy and sustainability of high-definition so-tDCS for managing SCD and sleep disturbances in older adults. The neurophysiological signal detector will be featured with a compact and high-performing GSR assessor with the state-of-the-art personalized measurement during so-tDCS. The successful implement of this signal detector will provide researchers assess to an "add-on" setting that allows them easily, quickly and quantitatively evaluate real-time neurophysiological signals and further incorporate transcranial brain stimulation in clinical practice.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
60 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Chinese, right-handed, aged from 60 to 85 years.
  • Normal global cognition defined as a total score of the Montreal Cognitive Assessment Hong Kong version (HK MoCA) >
  • Subjective cognitive decline (SCD) is evaluated by a 10-item questionnaire that covers subjective cognitive complaints (SCC) in the core cognitive domains.
  • Sleep disturbances or poor sleep quality is assessed and defined with a total score of the Pittsburgh Sleep Quality Index (PSQI) greater than 5.

排除标准

  • Previous diagnosis of age-related neurodegenerative diseases, such as Alzheimer's disease, Parkinson disease.
  • 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.

研究组 & 干预措施

Slow-oscillatory transcranial direct current stimulation

Active Comparator

干预措施: so-tDCS (Device)

Sham transcranial direct current stimulation

Sham Comparator

干预措施: Sham so-tDCS (Device)

结局指标

主要结局

Impedance

时间窗: 12 weeks

A neurophysiological signal recorded and measured by a built-in wearable Galvanic Skin Response (GSR) sensor. The GSR sensor is placed on the fingers to detect the impedance of the skin when the participant is receiving the so-tDCS intervention

Subjective cognitive complaints (SCC)

时间窗: 12 weeks

SCC is a 10-item questionnaire that covers subjective complaints in the core cognitive domains. Participants will answer ten yes/no questions relating to the presence of cognitive complaints in the last six months. The answers of SCC are codified as 0 (no complaints) or 1 (presence of complaints). Answers will be summed up and the total of complaints will be obtained ranging from 0 to 10.

Pittsburg Sleep Quality Index (PSQI)

时间窗: 12 weeks

The PSQI is a 19-item questionnaire that includes seven areas of subjective sleep quality and patterns in adults over the last month including the following components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, SDs, use of sleeping medications, and daytime dysfunction. Each item in the scale is scored from 0 to 3 scale (0 = no difficulty; 3 = severe difficulty). The scores are added to yield a global score ranging from 0 to 21 (0 = no difficulty; 21 = severe difficulties in all areas). This scale has good reliability and validity psychometrics and is widely used in research: Cronbach's alpha (0.77 to 0.83), sensitivity (89.6%), specificity (86.5%). Greater score of PSQI indicates worse sleep quality.

次要结局

  • Intra-individual variability of reaction time (IIV-RT)(12 weeks)
  • Objective sleep quality(12 weeks)
  • The levels of saliva Aβ(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

LU Hanna

Assistant Professor

Chinese University of Hong Kong

研究点 (1)

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