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

NCT06169254 | Completed

• 1 other identifier: 2023.074
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disorders, Circadian Rhythm; Cognitive Impairment; Vascular Dementia

Keywords

Aging; Transcranial current stimulation; Sleep disturbance; Randomized clinical trial

Outcome Measures

Primary Outcomes (3)

• 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.

  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

Secondary Outcomes (3)

• Objective assessment of circadian rhythm

  12 weeks

• Global cognition

  12 weeks

• Learning and memory function

  12 weeks

Study Arms (3)

High-frequency Transcranial Random Noise Stimulation (Hf-tRNS)

ACTIVE COMPARATOR

The stimulation parameters of hf-tACS include: 20 minutes at 101-640 Hz, 2 milliamps.

Device: Transcranial current stimulation (tCS)

Transcranial alternating current stimulation (tACS)

ACTIVE COMPARATOR

The stimulation parameters of HD-tACS include: 20 minutes at 40 Hz, 2 milliamps.

Device: Transcranial current stimulation (tCS)

Sham transcranial current stimulation (tCS)

SHAM COMPARATOR

In sham condition, the stimulation only last for 30 seconds with the electrodes left in place for a further 20 minutes.

Device: Transcranial current stimulation (tCS)

Interventions

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.

High-frequency Transcranial Random Noise Stimulation (Hf-tRNS); Sham transcranial current stimulation (tCS); Transcranial alternating current stimulation (tACS)

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, 100000, Hong Kong

Location

Related Publications (1)

• 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.

  PMID: 39441802 DERIVED

MeSH Terms

Conditions

Sleep Disorders, Circadian Rhythm; Cognitive Dysfunction; Dementia, Vascular; Parasomnias

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Chronobiology Disorders; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Occupational Diseases; Mental Disorders; Cognition Disorders; Neurocognitive Disorders; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Dementia; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Hanna LU, PhD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: December 13, 2023
• Study Start: August 1, 2023
• Primary Completion: August 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)