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

NCT ID: NCT06169254

Last Updated: 2025-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2024-12-31

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.

Conditions

Sleep Disorders, Circadian Rhythm; Cognitive Impairment; Vascular Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

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

Group Type: ACTIVE_COMPARATOR

Transcranial current stimulation (tCS)

Intervention Type: 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.

Transcranial alternating current stimulation (tACS)

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

Group Type: ACTIVE_COMPARATOR

Transcranial current stimulation (tCS)

Intervention Type: 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.

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.

Group Type: SHAM_COMPARATOR

Transcranial current stimulation (tCS)

Intervention Type: 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.

Interventions

Transcranial current stimulation (tCS)

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

LU Hanna

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hanna LU, PhD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

The Chinese University of Hong Kong

Hong Kong, , Hong Kong

Countries

Hong Kong

References

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.

Reference Type: DERIVED

PMID: 39441802 (View on PubMed)

Other Identifiers

2023.074

Identifier Type: -

Identifier Source: org_study_id