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

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ClinicalTrials.gov Identifier: NCT04087499
Recruitment Status : Recruiting
First Posted : September 12, 2019
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

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.


Condition or disease Intervention/treatment Phase
Vascular Cognitive Impairment Device: Acupuncture Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Potential Role of Acupuncture Treatment in Neuronal and Network Dysfunction in Patients With Vascular Cognitive Impairment
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
Sham Comparator: regular medication treatment
regular medication treatment
Device: Acupuncture
acupuncture treatment on selected acupoint

Experimental: acupuncture and regular medication treatment
acupuncture and regular medication treatment
Device: Acupuncture
acupuncture treatment on selected acupoint




Primary Outcome Measures :
  1. Change from baseline sleep quality at 3 months, 6 months, 12 months [ Time Frame: 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 :
  1. Change from baseline neuro-behavioral performances at 3 months, 6 months, 12 months [ Time Frame: 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.

  2. Change from baseline motor function (UPDRS) at 3 months, 6 months, 12 months [ Time Frame: 3 months, 6 months, 12 months ]
    Unified Parkinson's Disease Rating Scale (UPDRS)-part III scores for parkinsonian features.

  3. Change from baseline motor function (NIHSS) at 3 months, 6 months, 12 months [ Time Frame: 3 months, 6 months, 12 months ]
    NIH Stroke Scale (NIHSS) score 0-24.

  4. Change from baseline continuous motor function at 3 months, 6 months, 12 months [ Time Frame: 3 months, 6 months, 12 months ]
    Physical activity was measured using accelerometers.

  5. Change from baseline memory performances at 3 months, 6 months, 12 months [ Time Frame: 3 months, 6 months, 12 months ]
    Verbal memory were evaluated by using Chinese Version Verbal Learning Test (CVVLT).Visual-spatial abilities.

  6. Change from baseline executive performances at 3 months, 6 months, 12 months [ Time Frame: 3 months, 6 months, 12 months ]
    Attention and executive function was evaluated by Trail Making Test B.

  7. Change from baseline executive performances (Stroop interference test) at 3 months, 6 months, 12 months [ Time Frame: 3 months, 6 months, 12 months ]
    Attention and executive function was evaluated by Stroop interference test.

  8. Change from baseline executive performances (calculation) at 3 months, 6 months, 12 months [ Time Frame: 3 months, 6 months, 12 months ]
    As the calculation ability depends on executive function, calculation ability was evaluated to reflect part of executive function.

  9. Change from baseline abstract thinking at 3 months, 6 months, 12 months [ Time Frame: 3 months, 6 months, 12 months ]
    Abstract reasoning was evaluated by using similarities (conceptualization) in frontal assessment battery-Similarities.

  10. Change from baseline language performances at 3 months, 6 months, 12 months [ Time Frame: 3 months, 6 months, 12 months ]
    Boston Naming Test were used to evaluate language ability in naming.

  11. Change from baseline fluency performances at 3 months, 6 months, 12 months [ Time Frame: 3 months, 6 months, 12 months ]
    Semantic category fluency.

  12. Change from baseline neuropsychiatric symptoms at 3 months, 6 months, 12 months [ Time Frame: 3 months, 6 months, 12 months ]
    The neuropsychiatric symptoms of the participants were measured using the Neuropsychiatric Inventory.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04087499


Contacts
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Contact: YaTing Chang, MD,PhD 077317123 emily0606@cgmh.org.tw

Locations
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Taiwan
Kaohsiung Chang Gung Memorial Hospital Recruiting
Kaohsiung, Taiwan, 83301
Contact: YaTing Chang    077317123    emily0606@cgmh.org.tw   
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: YaTing Chang, MD,PhD Chang Gung Memorial Hospital

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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT04087499     History of Changes
Other Study ID Numbers: 201802103A3
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders