Clinical trial NCT04087499: Potential Role of Acupuncture Treatment in Neuronal and Network Dysfunction in Patients With Vascular Cognitive Impairment
Official title: Potential Role of Acupuncture Treatment in Neuronal and Network Dysfunction in Patients With Vascular Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vascular Cognitive Impairment
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2019-09-12
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline sleep quality at 3 months, 6 months, 12 months
timeFrame: 3 months, 6 months, 12 months
Secondary outcomes:
measure: Change from baseline neuro-behavioral performances at 3 months, 6 months, 12 months
timeFrame: 3 months, 6 months, 12 months
measure: Change from baseline motor function (UPDRS) at 3 months, 6 months, 12 months
timeFrame: 3 months, 6 months, 12 months
measure: Change from baseline motor function (NIHSS) at 3 months, 6 months, 12 months
timeFrame: 3 months, 6 months, 12 months
measure: Change from baseline continuous motor function at 3 months, 6 months, 12 months
timeFrame: 3 months, 6 months, 12 months
measure: Change from baseline memory performances at 3 months, 6 months, 12 months
timeFrame: 3 months, 6 months, 12 months
measure: Change from baseline executive performances at 3 months, 6 months, 12 months
timeFrame: 3 months, 6 months, 12 months
measure: Change from baseline executive performances (Stroop interference test) at 3 months, 6 months, 12 months
timeFrame: 3 months, 6 months, 12 months
measure: Change from baseline executive performances (calculation) at 3 months, 6 months, 12 months
timeFrame: 3 months, 6 months, 12 months
measure: Change from baseline abstract thinking at 3 months, 6 months, 12 months
timeFrame: 3 months, 6 months, 12 months
measure: Change from baseline language performances at 3 months, 6 months, 12 months
timeFrame: 3 months, 6 months, 12 months
measure: Change from baseline fluency performances at 3 months, 6 months, 12 months
timeFrame: 3 months, 6 months, 12 months
measure: Change from baseline neuropsychiatric symptoms at 3 months, 6 months, 12 months
timeFrame: 3 months, 6 months, 12 months
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: YaTing Chang, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: