High-frequency Transcranial Random Noise Stimulation (Hf-tRNS) for Sleep Disturbances in Neurocognitive Disorders Due to Vascular Disease
Sponsor study identifier
interventional
30
1 country
1
Study Start
August 1, 2023
Actual (reported)Primary Completion
August 31, 2024
Actual (reported)Study Completion
December 31, 2024
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2024
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 1, 2023
Actual (reported)December 5, 2023
Actual (reported)December 13, 2023
Actual (reported)August 31, 2024
Actual (reported)December 31, 2024
Actual (reported)Pittsburg Sleep Quality Index (PSQI)
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.
12 weeks
Attentional function
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.
The stimulation parameters of hf-tACS include: 20 minutes at 101-640 Hz, 2 milliamps.
The stimulation parameters of HD-tACS include: 20 minutes at 40 Hz, 2 milliamps.
In sham condition, the stimulation only last for 30 seconds with the electrodes left in place for a further 20 minutes.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The Chinese University of Hong Kong
Hong Kong, 100000, Hong Kong
Gong Y, Li J, Yuen YS, Yang NS, Li Z, Tang WK, Lu H. Daily high-frequency transcranial random noise stimulation (hf-tRNS) for sleep disturbances and cognitive dysfunction in patients with mild vascular cognitive impairments: A study protocol for a pilot randomized controlled trial. PLoS One. 2024 Oct 23;19(10):e0309233. doi: 10.1371/journal.pone.0309233. eCollection 2024.
Hanna LU, PhD
Chinese University of Hong Kong
30 participants (actual enrollment reported by the registry).
First Submitted
December 5, 2023
First Posted
December 13, 2023
Study Start
August 1, 2023
Actual (reported)A Stand-alone Therapeutic Music-with-Movement Programme for People With Cognitive Impairment
12 weeks
Executive function
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.
12 weeks
Objective assessment of circadian rhythm
12 weeks
Global cognition
12 weeks
Learning and memory function
12 weeks
Contact the study team to confirm eligibility.
Primary Completion
August 31, 2024
Actual (reported)Study Completion
December 31, 2024
Actual (reported)Last Updated
January 14, 2025
Record last verified: 2025-01
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