Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000719831
Ethics application status
Approved
Date submitted
4/07/2012
Date registered
5/07/2012
Date last updated
5/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of Acupuncture on Cognitive Function in Healthy Adults
Scientific title
Effects in healthy adults undergoing acupuncture in comparison to a wait-list control group in cognitive function outcomes.
Secondary ID [1] 280779 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive function 286837 0
Condition category
Condition code
Mental Health 287149 287149 0 0
Studies of normal psychology, cognitive function and behaviour
Alternative and Complementary Medicine 287162 287162 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will undergo 3 x 30 minute acupuncture session per week for 2 weeks (6 session in total).
Manual acupuncture will be administered by a same qualified acupuncturist throughout the study on four chosen acupoints (ST36 (Zusanli), HT7 (Shenmen), GV20 (Baihui) and CV12 (Zhongwang)).
All participants will be treated with disposable sterile stainless steel needles (size 40mm×0.30mm for ST36 (Zusanli) and 25mm×0.30mm for all other points).
Each treatment will run for approximately 30 minutes. The needles will be inserted perpendicular to the skin surface and inserted to a depth of up to 2cm depending on the acupoint.
These needles will be rotated backwards and forwards with an even motion at a rate of 60hz with an amplitude of 180 degree. Manipulation on each acupoint will be done immediately after needle insertion, at 15 minutes and immediately prior to removal of the needles. Stimulation on each point will last for 30 seconds.
The different ‘deqi’ or acupuncture sensations experienced by the subject during needle manipulation including aching, soreness, numbness, and distension will be scored by the participant on a scale of 0–5 after every procedure.
It was the acupuncturist’s aim to generate ‘deqi’ or acupuncture sensations without provoking undue discomfort or sharp pain [Hui et al., 2000, 2005].
Intervention code [1] 285205 0
Prevention
Intervention code [2] 285206 0
Treatment: Other
Comparator / control treatment
The comparator in this study will be a no-treatment wait list control group. This group will undergo the same testing procedures as the active intervention group however will not recieve any acupuncture treatment.
Once they have completed the study within the wait list group they will be given the option to recieve acupuncture treatment.
This serves the purpose of providing an untreated comparison for the active group to examine the potential effects of acupuncture on cognitive function, while at the same time allowing the wait-listed participants an opportunity to obtain the intervention at a later date.
Control group
Active

Outcomes
Primary outcome [1] 287460 0
The primary outcome in this study is the effect of acupuncture on cognitive performance.
This will be measured by the Computerised Mental Performance Assessment System (COMPASS) which will be employ a range of computerised tasks to assess attention, short-term and working memory, executive and visospatial function
Timepoint [1] 287460 0
Primary endpoints will be the results from the COMPASS measured before any treatment and after all 6 acupuncture treatment only.
Secondary outcome [1] 298205 0
The secondary outcome measure in this study will be evoked potentials assessed with non-invasively electroencephalogram (EEG).
Visual and auditory P300 waveforms will be assessed for changes in amplitude and latency.
Frequency power will also be assessed using the EEG.
Timepoint [1] 298205 0
Secondary endpoints will be the results from the EEG measured before any treatment and after all 6 acupuncture treatment only.

Eligibility
Key inclusion criteria
Healthy adults aged between 25 and 75 years of age
Non-smoker
Mini Mental State Exam (MMSE) score > 21
Minimum age
25 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Use of acupuncture within a month.
- Current use of cognitive therapies such as gingko biloba or other supplements
- History of severe diseases such as diabetes with complications, asthma, serious pulmonary disorders; history of insomnia, anxiety, epilepsy, psychiatric disorders.
- Any mental illness as reported by the potential participant
- History of drug or alcohol abuse
- Pregnancy

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be briefed and informed consent obtained prior to the screening session. The screening session will be used to determine a participant's eligibility.
Once they have been deemed eligible, they will be formally enrolled and provided with a study identification number.
They will then be allocated to either a wait list control or active treatment group. Participants and study researchers will not be blinded however allocation will be concealed and randomised by the CompleMED Research Program Coordinator who is external to the research team. Allocations will be individually sealed according to participant enrollment and only opened once a participant is fully enrolled
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised via a computer randomisation package conducted externally to the research team by a CompleMED Research Program Coordinator. The researchers will be concealed to the randomisation process.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
This study is a parallel group, randomized wait list-controlled pilot study.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/07/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5497 0
2560

Funding & Sponsors
Funding source category [1] 285566 0
University
Name [1] 285566 0
University of Western Sydney
Country [1] 285566 0
Australia
Primary sponsor type
University
Name
University of Western Sydney
Address
Centre for Complementary Medicine Research (CompleMED)
University of Western Sydney
Campbelltown Campus, Building 5
Locked Bag 1797, Penrith
NSW 2751
Country
Australia
Secondary sponsor category [1] 284403 0
None
Name [1] 284403 0
Address [1] 284403 0
Country [1] 284403 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287584 0
University of Western Sydney Human Research Ethics Committee
Ethics committee address [1] 287584 0
Office of Research Services
Kingswood Campus, Building K
Locked Bag 1797
Penrith NSW 2751
Ethics committee country [1] 287584 0
Australia
Date submitted for ethics approval [1] 287584 0
30/04/2012
Approval date [1] 287584 0
13/06/2012
Ethics approval number [1] 287584 0
H8196

Summary
Brief summary
The purpose of this study is aim to determine whether acute acupuncture intervention can improve cognitive functionality in a cohort of relatively healthy participants.

We hypothesize that there will be a statistically significant increase in both behavioural and physiological measures of cognitive performance in comparison to untreated control after six acupuncture treatments.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34393 0
Address 34393 0
Country 34393 0
Phone 34393 0
Fax 34393 0
Email 34393 0
Contact person for public queries
Name 17640 0
Yu-Ting Sun
Address 17640 0
Centre for Complementary Medicine Research (CompleMED)
University of Western Sydney
Campbelltown Campus, Building 5
Locked Bag 1797, Penrith
NSW 2751
Country 17640 0
Australia
Phone 17640 0
+612 4620 3278
Fax 17640 0
Email 17640 0
[email protected]
Contact person for scientific queries
Name 8568 0
Yu-Ting Sun
Address 8568 0
Centre for Complementary Medicine Research (CompleMED)
University of Western Sydney
Campbelltown Campus, Building 5
Locked Bag 1797, Penrith
NSW 2751
Country 8568 0
Australia
Phone 8568 0
+612 4620 3278
Fax 8568 0
Email 8568 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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