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

Primary Purpose

Vascular Cognitive Impairment

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vascular Cognitive Impairment

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kaohsiung Chang Gung Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

regular medication treatment

acupuncture and regular medication treatment

Arm Description

regular medication treatment

acupuncture and regular medication treatment

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
Change from baseline motor function (NIHSS) at 3 months, 6 months, 12 months
NIH Stroke Scale (NIHSS) score 0-24.
Change from baseline continuous motor function at 3 months, 6 months, 12 months
Physical activity was measured using accelerometers.
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.
Change from baseline executive performances at 3 months, 6 months, 12 months
Attention and executive function was evaluated by Trail Making Test B.
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.
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.
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.
Change from baseline language performances at 3 months, 6 months, 12 months
Boston Naming Test were used to evaluate language ability in naming.
Change from baseline fluency performances at 3 months, 6 months, 12 months
Semantic category fluency.
Change from baseline neuropsychiatric symptoms at 3 months, 6 months, 12 months
The neuropsychiatric symptoms of the participants were measured using the Neuropsychiatric Inventory.

Full Information

First Posted
August 18, 2019
Last Updated
October 1, 2019
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04087499
Brief Title
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

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
July 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Cognitive Impairment

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
regular medication treatment
Arm Type
Sham Comparator
Arm Description
regular medication treatment
Arm Title
acupuncture and regular medication treatment
Arm Type
Experimental
Arm Description
acupuncture and regular medication treatment
Intervention Type
Device
Intervention Name(s)
Acupuncture
Intervention Description
acupuncture treatment on selected acupoint
Primary Outcome Measure Information:
Title
Change from baseline sleep quality at 3 months, 6 months, 12 months
Description
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
Time Frame
3 months, 6 months, 12 months
Secondary Outcome Measure Information:
Title
Change from baseline neuro-behavioral performances at 3 months, 6 months, 12 months
Description
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.
Time Frame
3 months, 6 months, 12 months
Title
Change from baseline motor function (UPDRS) at 3 months, 6 months, 12 months
Description
Unified Parkinson's Disease Rating Scale (UPDRS)-part III scores for parkinsonian features.
Time Frame
3 months, 6 months, 12 months
Title
Change from baseline motor function (NIHSS) at 3 months, 6 months, 12 months
Description
NIH Stroke Scale (NIHSS) score 0-24.
Time Frame
3 months, 6 months, 12 months
Title
Change from baseline continuous motor function at 3 months, 6 months, 12 months
Description
Physical activity was measured using accelerometers.
Time Frame
3 months, 6 months, 12 months
Title
Change from baseline memory performances at 3 months, 6 months, 12 months
Description
Verbal memory were evaluated by using Chinese Version Verbal Learning Test (CVVLT).Visual-spatial abilities.
Time Frame
3 months, 6 months, 12 months
Title
Change from baseline executive performances at 3 months, 6 months, 12 months
Description
Attention and executive function was evaluated by Trail Making Test B.
Time Frame
3 months, 6 months, 12 months
Title
Change from baseline executive performances (Stroop interference test) at 3 months, 6 months, 12 months
Description
Attention and executive function was evaluated by Stroop interference test.
Time Frame
3 months, 6 months, 12 months
Title
Change from baseline executive performances (calculation) at 3 months, 6 months, 12 months
Description
As the calculation ability depends on executive function, calculation ability was evaluated to reflect part of executive function.
Time Frame
3 months, 6 months, 12 months
Title
Change from baseline abstract thinking at 3 months, 6 months, 12 months
Description
Abstract reasoning was evaluated by using similarities (conceptualization) in frontal assessment battery-Similarities.
Time Frame
3 months, 6 months, 12 months
Title
Change from baseline language performances at 3 months, 6 months, 12 months
Description
Boston Naming Test were used to evaluate language ability in naming.
Time Frame
3 months, 6 months, 12 months
Title
Change from baseline fluency performances at 3 months, 6 months, 12 months
Description
Semantic category fluency.
Time Frame
3 months, 6 months, 12 months
Title
Change from baseline neuropsychiatric symptoms at 3 months, 6 months, 12 months
Description
The neuropsychiatric symptoms of the participants were measured using the Neuropsychiatric Inventory.
Time Frame
3 months, 6 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Fulfill the diagnostic criteria of vascular cognitive impairment Exclusion Criteria: Systemic inflammatory disease with on-going treatment Severe psychiatric disease, such as major depressive disorder or schizophrenia Severe traumatic brain injury Unable to tolerate exam of brain MRI
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
YaTing Chang, MD,PhD
Phone
077317123
Email
emily0606@cgmh.org.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YaTing Chang, MD,PhD
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
YaTing Chang
Phone
077317123
Email
emily0606@cgmh.org.tw

12. IPD Sharing Statement

Plan to Share IPD
No

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

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