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.

Study Overview

• Status: Unknown
• Conditions: Vascular Cognitive Impairment
• Intervention / Treatment: Device: Acupuncture

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 83301
    • Recruiting
    • Kaohsiung Chang Gung Memorial Hospital
    • Contact: YaTing Chang; Phone Number: 077317123; Email: emily0606@cgmh.org.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: regular medication treatment	Device: Acupuncture; acupuncture treatment on selected acupoint
Experimental: acupuncture and regular medication treatment	Device: Acupuncture; acupuncture treatment on selected acupoint

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
Change from baseline fluency performances at 3 months, 6 months, 12 months	Semantic category fluency.	3 months, 6 months, 12 months
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

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: YaTing Chang, MD,PhD, Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: August 18, 2019
• First Submitted That Met QC Criteria: September 11, 2019
• First Posted (Actual): September 12, 2019

Study Record Updates

• Last Update Posted (Actual): October 3, 2019
• Last Update Submitted That Met QC Criteria: October 1, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 201802103A3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No