Skip to content

Potential Role of Acupuncture Treatment in Neuronal and Network Dysfunction in Patients With Vascular Cognitive Impairment

Potential Role of Acupuncture Treatment in Neuronal and Network Dysfunction in Patients With Vascular Cognitive Impairment

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04087499
Enrollment
80
Registered
2019-09-12
Start date
2019-09-01
Completion date
2022-07-31
Last updated
2019-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vascular Cognitive Impairment

Brief summary

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.

Detailed description

Stroke is a common cerebrovascular disease of the central nervous system leading to serious medical complication. It results in a high mortality rate and increased disability rate. Stroke survivors may have long-lasting consequences, including motor dysfunction, sensibility dysfunction, and cognitive impairment\]. Cognition is a key component of rehabilitation and recovery; therefore it is associated with poor engagement in rehabilitee and outcomes including increased mortality. As vascular dementia (VaD) is considered the second-most-common type of dementing illness, accounting for a significant proportion of total dementia case, vascular cognitive impairment (VCI) is a broader dimensional term, ranging from mild cognitive impairment without incapacity on activity of daily living to VaD, referred to as significant cognitive impairment and decline in function status. Acupuncture is an ancient Chinese medical technique in which fine, stainless steel needles are inserted into certain anatomical locations of the body surface to elicit neurohormonal responses of the body system via nerve stimulation. Acupuncture are reported to be probably effective in improving cognitive function in vascular dementia animal models via multiple mechanisms such as anti-apoptosis, antioxidative stress reaction, and metabolism enhancing of glucose and oxygen. Motor features may not parallel to the cognitive changes, it will serve as the disease progression marker. Unified Parkinson's Disease Rating Scale (UPDRS)-part III scores and NIH Stroke Scale (NIHSS) will be used. 1. At Kaohsiung Chang Gung Memorial Hospital, all the patients (n=80) will be included and receive a Standardized Acupuncture intervention; 40 will be treated with regular medication; 40 will be treated with acupuncture and regular medication. 2. For acupressure program, all participants are treated in supine position, and a certified TCM physician applied firm pressure (3 to 5 kg of pressure) with fingertips in a circular motion at a speed of 2 circles per second for a duration of one minute per acupoint. The complete process lasts for 8 minutes. Cognitive function, Motor function, Mood and Sleep will be evaluated at baseline and follow-up period of time at 3 month, 6 month, and 12 month.

Interventions

DEVICEAcupuncture

acupuncture treatment on selected acupoint

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline sleep quality at 3 months, 6 months, 12 months3 months, 6 months, 12 monthsAnalogous 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

Secondary

MeasureTime frameDescription
Change from baseline motor function (UPDRS) at 3 months, 6 months, 12 months3 months, 6 months, 12 monthsUnified Parkinson's Disease Rating Scale (UPDRS)-part III scores for parkinsonian features.
Change from baseline motor function (NIHSS) at 3 months, 6 months, 12 months3 months, 6 months, 12 monthsNIH Stroke Scale (NIHSS) score 0-24.
Change from baseline continuous motor function at 3 months, 6 months, 12 months3 months, 6 months, 12 monthsPhysical activity was measured using accelerometers.
Change from baseline memory performances at 3 months, 6 months, 12 months3 months, 6 months, 12 monthsVerbal memory were evaluated by using Chinese Version Verbal Learning Test (CVVLT).Visual-spatial abilities.
Change from baseline executive performances at 3 months, 6 months, 12 months3 months, 6 months, 12 monthsAttention and executive function was evaluated by Trail Making Test B.
Change from baseline neuro-behavioral performances at 3 months, 6 months, 12 months3 months, 6 months, 12 monthsCognitive 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.
Change from baseline executive performances (calculation) at 3 months, 6 months, 12 months3 months, 6 months, 12 monthsAs the calculation ability depends on executive function, calculation ability was evaluated to reflect part of executive function.
Change from baseline abstract thinking at 3 months, 6 months, 12 months3 months, 6 months, 12 monthsAbstract reasoning was evaluated by using similarities (conceptualization) in frontal assessment battery-Similarities.
Change from baseline language performances at 3 months, 6 months, 12 months3 months, 6 months, 12 monthsBoston Naming Test were used to evaluate language ability in naming.
Change from baseline fluency performances at 3 months, 6 months, 12 months3 months, 6 months, 12 monthsSemantic category fluency.
Change from baseline neuropsychiatric symptoms at 3 months, 6 months, 12 months3 months, 6 months, 12 monthsThe neuropsychiatric symptoms of the participants were measured using the Neuropsychiatric Inventory.
Change from baseline executive performances (Stroop interference test) at 3 months, 6 months, 12 months3 months, 6 months, 12 monthsAttention and executive function was evaluated by Stroop interference test.

Countries

Taiwan

Contacts

Primary ContactYaTing Chang, MD,PhD
emily0606@cgmh.org.tw077317123

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026