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

NCT ID: NCT04087499

Last Updated: 2019-10-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2022-07-31

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.

Conditions

Vascular Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

regular medication treatment

regular medication treatment

Group Type: SHAM_COMPARATOR

Acupuncture

Intervention Type: DEVICE

acupuncture treatment on selected acupoint

acupuncture and regular medication treatment

acupuncture and regular medication treatment

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: DEVICE

acupuncture treatment on selected acupoint

Interventions

Acupuncture

acupuncture treatment on selected acupoint

Intervention Type: DEVICE

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

YaTing Chang, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Locations

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

YaTing Chang, MD,PhD

Role: CONTACT

emily0606@cgmh.org.tw

077317123

Facility Contacts

YaTing Chang

Role: primary

emily0606@cgmh.org.tw

077317123

Other Identifiers

201802103A3

Identifier Type: -

Identifier Source: org_study_id