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Completed

NCT Number: NCT06169254

High-frequency tRNS for Sleep Disturbances in Neurocognitive Disorders Due to Vascular Disease

The investigators aim to 1) investigate and compare the safety, efficacy and sustainability of hf-tRNS, tACS and sham transcranial current stimulation (tCS) over left inferior parietal lobe (IPL) in mild neurocognitive disorder due to vascular disease (NCD-vascular) patients with sleep disturbances; 2) examine the relationship between the changes in sleep quality, cognitive function and brain morphometry.

Methods: Chinese right-handed mild NCD-AD patients with sleep disturbances (aged from 60 to 90 years) will be randomly assigned to a 2-week intervention of either hf-tRNS, tACS, or sham tCS, with 10 participants per arm. Before intervention, structural magnetic resonance imaging (MRI) data is used to construct individual realistic head model. Comprehensive assessments, including sleep quality, cognitive performance and blood pressure will be conducted at baseline, 2th week, 6th week and 12th week. Program adherence and adverse effects will be monitored throughout intervention.

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Key information

Conditions

Sleep Disorders, Circadian Rhythm Arterial Occlusive Diseases Arteriosclerosis Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Chronobiology Disorders Cognition Disorders Cognitive Dysfunction Cognitive Impairment Dementia Dementia, Vascular Dyssomnias Intracranial Arterial Diseases Intracranial Arteriosclerosis Leukoencephalopathies Mental Disorders Nervous System Diseases Neurocognitive Disorders Occupational Diseases Parasomnias Sleep Wake Disorders Vascular Dementia Vascular Diseases

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Chinese University of Hong Kong

Hong Kong, 100000

About this study

This study aims to investigate the feasibility, safety and efficacy of hf-tRNS and tACS over left IPL for sleep disturbances and cognitive dysfunction in mild NCD-vascular patients. It wills also test the program adherence, tolerability and adverse effects of this innovative neurotechonology. Information will be helpful for in-depth understanding the relationship of "sleep disturbances-cognition" and guiding the further studies of sleep medicine and neurodegenerative diseases.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chinese, right-handed, aged from 60 to 80 years.
  • With at least one cerebrovascular risk factor, e.g., a history of hypertension defined as systolic blood pressure (BP) 140 mm Hg or higher, diastolic BP of 90 mm Hg or higher; or receiving antihypertensive medication.
  • Score of Montreal Cognitive Assessment Hong Kong version (HK MoCA) range from 22 to 26 (Lu et al., 2019).
  • With preserved functional abilities reflected by a Functional Assessment Questionnaire score of 7 or lower (Hajjar et al., 2020).
  • With a medial temporal lobe atrophy (MTA) score < 2
  • No interference with independence in everyday activities.

Exclusion criteria

  • Previous diagnosis of dementia or stroke;
  • Past history of bipolar disorders or psychosis;
  • Physically frail affecting attendance to training sessions;
  • Already attending regular training, such as cognitive behavioral therapy;
  • Taking a psychotropic or other medication known to affect cognition (e.g. anti-dementia medication);
  • Significant communicative impairments.

Treatment and study plan

Transcranial current stimulation (tCS)

Device

Transcranial current stimulation (tCS) is delivered by a battery driven direct current stimulator (DC-Stimulator Plus, NeuroConn, Ilmenau, Germany) through a central anodal electrode surrounded by four return cathodal electrodes.

Primary outcomes

  1. Pittsburg Sleep Quality Index (PSQI)

    Time frame: 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 (Buysse et al., 1988). 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%)(Buysse et al., 1988). Greater score of PSQI indicates worse sleep quality.

  2. Attentional function

    Time frame: 12 weeks

    Complex attention is measured by attention network test (ANT). The ANT paradigm is run by E-Prime 3.0 software. Within ANT paradigm, there are four types of cue: no cue, center cue, double cue, and spatial cue; and three types of flanker: neutral, congruent, and incongruent. The reaction time (RT) under different types of flanker indicates the efficacy of attention. Greater score indicates lower efficacy of attentional components.

  3. Executive function

    Time frame: 12 weeks

    Executive function is measured by the category verbal fluency test (CVFT). On each trial, the participants will be asked to overtly generate words in the animal category, fruit category and vegetable category as many as possible within 60 seconds. The total number of correct words is used to measure executive function.

Secondary outcomes

  1. Objective assessment of circadian rhythm

    Time frame: 12 weeks

    Actigraphic records were used to quantify sleep-wake cycle and estimate the objective sleep efficiency.

  2. Global cognition

    Time frame: 12 weeks

    Montreal Cognitive Assessment Hong Kong version (HK MoCA), which is validated global assessment sensitive to detect early cognitive dysfunction in neurocognitive disorder. A total score of HK MoCA less than 26 indicates mild cognitive impairment.

  3. Learning and memory function

    Time frame: 12 weeks

    Word-list learning test (WLLT), consisting of ten semantically non-associated words that is presented consecutively over three free trials of immediate recall, a 20-min delayed recall (to prevent recency effects).

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

High-frequency Transcranial Random Noise Stimulation (Hf-tRNS) for Sleep Disturbances in Neurocognitive Disorders Due to Vascular Disease

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 13, 2023
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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