Vascular Cognitive Impairment Clinical Trial
Official title:
Potential Role of Acupuncture Treatment in Neuronal and Network Dysfunction in Patients With Vascular Cognitive Impairment
Vascular cognitive impairment (VCI) is a broad dimensional term, ranging from mild cognitive
impairment without incapacity on activity of daily living to vascular dementia (VaD),
referred to as significant cognitive impairment and decline in function status.
In this three-year project, we aim to evaluate the effects of biochemical data, early
clinical variables, neuroimaging results, and intervention of acupuncture treatment on
vascular event related cognitive impairment in crossectional analysis and longitudinal
follow-up.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | July 2022 |
Est. primary completion date | September 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1. Fulfill the diagnostic criteria of vascular cognitive impairment Exclusion Criteria: 1. Systemic inflammatory disease with on-going treatment 2. Severe psychiatric disease, such as major depressive disorder or schizophrenia 3. Severe traumatic brain injury 4. Unable to tolerate exam of brain MRI |
Country | Name | City | State |
---|---|---|---|
Taiwan | Kaohsiung Chang Gung Memorial Hospital | Kaohsiung |
Lead Sponsor | Collaborator |
---|---|
Chang Gung Memorial Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline sleep quality at 3 months, 6 months, 12 months | Analogous variables were extracted from actigraphy. The sleep variables collected were sleep start time, sleep end time, sleep duration, sleep efficiency, and wake after sleep onset time, and the activity variables collected were heart rate activity score,activity amount, and activity intensity | 3 months, 6 months, 12 months | |
Secondary | Change from baseline neuro-behavioral performances at 3 months, 6 months, 12 months | Cognitive Abilities Screening Instrument (CASI). In addition to general cognitive performance, CASI was used to evaluate specific domains, including short-term memory, attention and concentration, abstraction, visual construction, language, and list-generating fluency. | 3 months, 6 months, 12 months | |
Secondary | Change from baseline motor function (UPDRS) at 3 months, 6 months, 12 months | Unified Parkinson's Disease Rating Scale (UPDRS)-part III scores for parkinsonian features. | 3 months, 6 months, 12 months | |
Secondary | Change from baseline motor function (NIHSS) at 3 months, 6 months, 12 months | NIH Stroke Scale (NIHSS) score 0-24. | 3 months, 6 months, 12 months | |
Secondary | Change from baseline continuous motor function at 3 months, 6 months, 12 months | Physical activity was measured using accelerometers. | 3 months, 6 months, 12 months | |
Secondary | Change from baseline memory performances at 3 months, 6 months, 12 months | Verbal memory were evaluated by using Chinese Version Verbal Learning Test (CVVLT).Visual-spatial abilities. | 3 months, 6 months, 12 months | |
Secondary | Change from baseline executive performances at 3 months, 6 months, 12 months | Attention and executive function was evaluated by Trail Making Test B. | 3 months, 6 months, 12 months | |
Secondary | Change from baseline executive performances (Stroop interference test) at 3 months, 6 months, 12 months | Attention and executive function was evaluated by Stroop interference test. | 3 months, 6 months, 12 months | |
Secondary | Change from baseline executive performances (calculation) at 3 months, 6 months, 12 months | As the calculation ability depends on executive function, calculation ability was evaluated to reflect part of executive function. | 3 months, 6 months, 12 months | |
Secondary | Change from baseline abstract thinking at 3 months, 6 months, 12 months | Abstract reasoning was evaluated by using similarities (conceptualization) in frontal assessment battery-Similarities. | 3 months, 6 months, 12 months | |
Secondary | Change from baseline language performances at 3 months, 6 months, 12 months | Boston Naming Test were used to evaluate language ability in naming. | 3 months, 6 months, 12 months | |
Secondary | Change from baseline fluency performances at 3 months, 6 months, 12 months | Semantic category fluency. | 3 months, 6 months, 12 months | |
Secondary | Change from baseline neuropsychiatric symptoms at 3 months, 6 months, 12 months | The neuropsychiatric symptoms of the participants were measured using the Neuropsychiatric Inventory. | 3 months, 6 months, 12 months |
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