ISRCTN - ISRCTN82980206: Effect of acupuncture treatment on Vascular Cognitive Impairment, No Dementia

Plain English Summary

Background and study aims
Cerebrovascular disease (conditions that are a result of problems with the blood vessels in the brain) and ischemic brain injury caused by heart disease are common causes of dementia and decline in cognitive (mental) function in the elderly. Reduced mental function without dementia (vascular cognitive impairment, no dementia [VCIND]) comprises a range of cognitive disorders related to cerebral vessel disease. A study on the progression of cognitive and functional impairment showed that 2% of VCIND patients died and 46% developed dementia. Unlike many other cognitive disorders, VCIND could be prevented or the course of cognitive decline could be improved. However, apart from controlling vascular risk factors, the effects of drug treatment on patients with VCIND are uncertain. Acupuncture is widely used for patients with neuropsychiatric disorders but there is a lack of information about its effectiveness. The aim of this study is to assess the effectiveness of acupuncture in the treatment of VCIND patients.

Who can participate?
Male and female patients aged 50-85 diagnosed with VCIND.

What does the study involve?
Participants will be randomly allocated to receive either acupuncture or a drug. The acupuncture group will receive two acupuncture sessions per week for 3 months. The drug group will be treated with oral citicoline three times per day for 3 months.

What are the possible benefits and risks of participating?
The results of this study may contribute to the future improvement of patient care. Participants may benefit from improved functional status and quality of life. The risks of taking part are minimal. Citicoline has been recommended in some European countries with a reliable safety profile. Acupuncture is a relatively safe treatment when given by properly trained clinicians. Occasionally acupuncture could make people feel nauseous or faint during or after treatment. Participants are warned of potential side effects before consenting to have the drug or acupuncture.

Where is the study run from?
This study will be carried out at four different centers in China: Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, Beijing Chinese Medicine Hospital in Huairou District, the Beijing Fengtai Hospital of Integrative Medicine, and Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine.

When is the study starting and how long is it expected to run for?
The study started in July 2013 will be recruiting patients until December 2015. The study is expected to complete in October 2016.

Who is funding the study?
Beijing Municipal Science & Technology Commission (China).

Who is the main contact?
Dr Liu Cun-Zhi
lcz623780@126.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Liu Cun-Zhi

ORCID ID

Contact details

Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University
23 Meishuguanhou Street
Dongcheng District
Beijing
100010
China
-
lcz623780@126.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

z131107002213034

Study information

Scientific title

Effect of acupuncture treatment on Vascular Cognitive Impairment, No Dementia: a multi-center, randomized, controlled trial

Acronym

VCIND

Study hypothesis

To investigate the effect of acupuncture on vascular cognitive impairment no dementia (VCIND).

Ethics approval

Ethics Committee of the Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, 22/03/2013, ref: 201317

Study design

Multi-center randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Vascular cognitive impairment not dementia（VCIND）

Intervention

All participants will be randomized to two different groups:
1. Acupuncture group: this group of patients will receive two acupuncture sessions per week for 3 months.
2. Drug group: this group of patients will receive oral citicoline 0.1g per time, 3 times per day for 3 months.

Intervention type

Mixed

Phase

Drug names

Primary outcome measure

The cognitive section of the Alzheimer Disease Assessment Scale (ADAS-Cog) will be assessed at baseline, the end of treatment and 3 months after the end of treatment.

Secondary outcome measures

1. Clock drawing test (CDT) will be assessed at baseline, the end of treatment and 3 months after the end of treatment.
2. Ability of daily living (ADL) and instrumental activities of daily living scale (IADL) will be assessed at baseline, the end of treatment and 3 months after the end of treatment.

Participants will report adverse events they experience, including discomfort or bruising at the sites of needle insertion, nausea, or feeling faint after each acupuncture treatment. Adverse drug reactions like nausea and vomiting, dizziness, dry mouth and itching will also be recorded.

Overall trial start date

01/07/2013

Overall trial end date

30/10/2016

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 55-85 years, either sex
2. Hachinski score ≥7
3. Evidence of vascular lesions on neuroradiology
4. Fluency in language sufficient to reliably complete all study assessments
5. Mini-Mental State Examination (MMSE) score >dementia threshold corrected based on educational year (>17 scores, >20 scores and >24 scores for 0, ≤6, and>6 educational years, respectively)
6. Montreal Cognitive Assessment (MoCA) <26 scores for >12 educational years (or <25 scores for≤12 educational years)
7. Written and informed consent

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

216

Participant exclusion criteria

1. History of mental diseases (e.g., schizophrenia, serious anxiety and depression)
2. Patients with Alzheimer's disease, Parkinson's disease, frontotemporal dementia or Huntington's disease
3. Patients with epilepsy and/or ever having antiepileptic drugs
4. Presence of serious heart diseases, kidney diseases or liver diseases

Recruitment start date

01/07/2013

Recruitment end date

01/12/2015

Locations

Countries of recruitment

China

Trial participating centre

Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University
Beijing
100010
China

Sponsor information

Organisation

Beijing Municipal Science & Technology Commission (China)

Sponsor type

Government

Website

http://www.bjkw.gov.cn/n8785584/index.html

Funders

Funder type