Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04087499
Other study ID # 201802103A3
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2019
Est. completion date July 2022

Study information

Verified date August 2019
Source Chang Gung Memorial Hospital
Contact YaTing Chang, MD,PhD
Phone 077317123
Email emily0606@cgmh.org.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date July 2022
Est. primary completion date September 2020
Accepts healthy volunteers No
Gender All
Age group 50 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Acupuncture
acupuncture treatment on selected acupoint

Locations

Country Name City State
Taiwan Kaohsiung Chang Gung Memorial Hospital Kaohsiung

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Change from baseline fluency performances at 3 months, 6 months, 12 months Semantic category fluency. 3 months, 6 months, 12 months
Secondary 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
See also
  Status Clinical Trial Phase
Recruiting NCT04604600 - Multimodal Biomarkers for Diagnosis and Prognosis in VCI Phase 3
Recruiting NCT04109963 - Trial of Remote Ischemic Pre-conditioning in Vascular Cognitive Impairment Phase 2
Not yet recruiting NCT05050604 - A Clinical Trial to Evaluate the Efficacy and Safety of Choline Alfoscerate in Vascular Cognitive Impairment Patients Phase 4
Not yet recruiting NCT05967728 - Testing of a System for Remote Ischemic Conditioning in Cerebral Small Vessel Disease and Pre-hospital Stroke Care Phase 2
Completed NCT03578614 - Impact of Physical Activity in Vascular Cognitive Impairment ( AFIVASC ) N/A
Recruiting NCT05079464 - Exercise as a Primer for Brain Stimulation in Vascular Cognitive Impairment No Dementia (VCIND) N/A
Completed NCT03545958 - The Heart & Mind Study N/A
Recruiting NCT05886114 - A Multi-domain Lifestyle Intervention Among Aged Community-residents in Zhejiang, China N/A
Completed NCT03228498 - Choline Alphoscerate-Nimodipine in Vascular Cognitive Impairment Phase 2
Completed NCT02669394 - Reshaping the Path of Vascular Cognitive Impairment (VCI) N/A
Recruiting NCT04916210 - Determinants of Incident Stroke Cognitive Outcomes and Vascular Effects on RecoverY
Recruiting NCT05349318 - Hyperbaric Oxygen Therapy for Prodromal Alzheimer´s Disease With Cerebrovascular Disease N/A
Active, not recruiting NCT05524181 - Telehealth-enabled Integrated Palliative Care for People With Dementia N/A
Completed NCT04301466 - Efficacy and Safety of Qi Zhi Tong Luo Capsule in Vascular Cognitive Impairment Phase 2/Phase 3
Recruiting NCT04999813 - Study on Early Brain Injury Mechanism and Comprehensive Intervention of VCI N/A
Completed NCT03625128 - 18F-PM-PBB3 PET Study in Tauopathy Including Alzheimer's Disease, Other Dementias and Normal Controls Early Phase 1
Completed NCT03383549 - Cognitive and Physical Home-rehabilitation by Information and Communications Technology. Games for Older Adults Active Life (GOAL) N/A
Recruiting NCT02524405 - BEAM: Brain-Eye Amyloid Memory Study
Completed NCT01027858 - PROMOTE: Promotion of the Mind Through Exercise N/A
Recruiting NCT05007353 - The SINgapore GERiatric Intervention Study to Reduce Cognitive Decline and Physical Frailty (SINGER) Study N/A