High-frequency Transcranial Random Noise Stimulation (Hf-tRNS) for Sleep Disturbances in Neurocognitive Disorders Due to Vascular Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Pittsburg Sleep Quality Index (PSQI)
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
High-frequency Transcranial Random Noise Stimulation (Hf-tRNS)
The stimulation parameters of hf-tACS include: 20 minutes at 101-640 Hz, 2 milliamps.
Intervention: Transcranial current stimulation (tCS) (Device)
Transcranial alternating current stimulation (tACS)
The stimulation parameters of HD-tACS include: 20 minutes at 40 Hz, 2 milliamps.
Intervention: Transcranial current stimulation (tCS) (Device)
Sham transcranial current stimulation (tCS)
In sham condition, the stimulation only last for 30 seconds with the electrodes left in place for a further 20 minutes.
Intervention: Transcranial current stimulation (tCS) (Device)
Outcomes
Primary Outcomes
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.
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.
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
- Learning and memory function(12 weeks)
- Global cognition(12 weeks)
- Objective assessment of circadian rhythm(12 weeks)
Investigators
LU Hanna
Assistant Professor
Chinese University of Hong Kong