Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06169254
Status:
RECRUITING
Last Update Posted:
2023-12-20
First Post:
2023-12-05
Brief Title:
High-frequency Transcranial Random Noise Stimulation Hf-tRNS for Sleep Disturbances in Neurocognitive Disorders Due to Vascular Disease
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
High-frequency Transcranial Random Noise Stimulation Hf-tRNS for Sleep Disturbances in Neurocognitive Disorders Due to Vascular Disease
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None