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

NCT04087499 | Unknown

• 1 other identifier: 201802103A3
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Vascular Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Change from baseline neuro-behavioral performances at 3 months, 6 months, 12 months

  3 months, 6 months, 12 months

• Change from baseline motor function (UPDRS) at 3 months, 6 months, 12 months

  3 months, 6 months, 12 months

• Change from baseline motor function (NIHSS) at 3 months, 6 months, 12 months

  3 months, 6 months, 12 months

• Change from baseline continuous motor function at 3 months, 6 months, 12 months

  3 months, 6 months, 12 months

• Change from baseline memory performances at 3 months, 6 months, 12 months

  3 months, 6 months, 12 months

Study Arms (2)

regular medication treatment

SHAM COMPARATOR

regular medication treatment

Device: Acupuncture

acupuncture and regular medication treatment

EXPERIMENTAL

acupuncture and regular medication treatment

Device: Acupuncture

Interventions

Acupuncture DEVICE

acupuncture treatment on selected acupoint

acupuncture and regular medication treatment; regular medication treatment

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Fulfill the diagnostic criteria of vascular cognitive impairment

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

RECRUITING

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• YaTing Chang, MD,PhD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

YaTing Chang, MD,PhD

CONTACT

077317123; emily0606@cgmh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2019
• First Posted: September 12, 2019
• Study Start: September 1, 2019
• Primary Completion: September 1, 2020
• Study Completion: July 1, 2022
• Last Updated: October 3, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)