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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
Functional Magnetic Resonance Imaging (fMRI) investigation of Laser Acupuncture on Acupoints useful in Mild to Moderate Depression : Healthy Subjects.
Scientific title
Functional magnetic resonance imaging (fMRI) of laser acupuncture on healthy subjects using highly significant acupoints for mild to moderate depression by randomised controlled trial.
Secondary ID [1] 251707 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild to moderate depression 257257 0
Condition category
Condition code
Alternative and Complementary Medicine 257396 257396 0 0
Other alternative and complementary medicine
Mental Health 257457 257457 0 0

Study type
Description of intervention(s) / exposure
1. Laser acupuncture on acupoints right LR14 ( 6th intercostal space midclavicular line), CV14 ( epigastrium 10 cm below the xiphisternum), HT7 at medial left wrist and LR8 at left medial knee region at junction of semitendinosus and semimembranosus muscles.
2. Interventions all in a single session.
3. Laser continuous beam 804nm, 25 mW output, each block of laser 20 seconds, total laser time 160seconds in the session.
4. Total time per session 30mins.
4. Block design laser-rest or sham-laser- rest or sham ( LRLR) with 9 rests and 8 active lasers to each acupoint.
Intervention code [1] 256375 0
Treatment: Other
Comparator / control treatment
All subjects receive both active laser and control or sham laser in the block design.
Control point on the abdomen at the level of the umbilicus midway between SP14 ( 20 cm lateral to umbilicus) and ST25 ( 10 cm lateral to the umbilicus. All acupoints have a positive vascular autonomic signal (VAS) palpable as an increased amplitude at the radial pulse. The control point was identified as a spot in this vicinity as described where there is no VAS.
Control group

Primary outcome [1] 258323 0
Brain positive and negative activations with functional magnetic imaging (fMRI) from active laser to each acupoint using statistical parametric mapping (SPM) analysis.
Timepoint [1] 258323 0
At the conclusion of the single session.
Secondary outcome [1] 264027 0
Brain positive and negative activations with functional magnetic imaging (fMRI) from sham laser to each acupoint using statistical parametric mapping (SPM) analysis.
Timepoint [1] 264027 0
At the conclusion of the single session.

Key inclusion criteria
1. Healthy subject
2. Right handed
3. Able to undergo magnetic resonance imaging
4. Able to provide informed consent.
Minimum age
18 Years
Maximum age
50 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
1. Intercurrent illness
2. Chronic illness including depressive disorder
3. Brain injury
4. Past surgery in the region of the acupoints
and control point.
5. Conditions contraindicated for magnetic
resonance imaging ( pacemaker, metal
foreign bodies)

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The subjects were recruited through internal email advertisements at the Prince of Wales Hospital and the University of New South Wales.
All subjects were treated with the 4 acupoints and the single control point.
Enrollment according to above inclusion and exclusion criteria.
No allocation concealment required for enrolment.
(Randomisation only applicable to order of laser to each acupoint in the subjects)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Order of laser to each acupoint was by simple randomisation by coin tossing.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Single group
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256882 0
Name [1] 256882 0
Prince of Wales Hospital
Address [1] 256882 0
Prof Perminder Sachdev
Neuropsychiatric Institute NPI
Prince of Wales Hospital PoWH
Barker Street
Randwick NSW 2031
Country [1] 256882 0
Primary sponsor type
Prince of Wales Hospital
Prof Perminder Sachdev
Neuropsychiatric Institute NPI
Prince of Wales Hospital PoWH
Barker Street
Randwick NSW 2031
Secondary sponsor category [1] 256154 0
Name [1] 256154 0
Address [1] 256154 0
Country [1] 256154 0
Other collaborator category [1] 1242 0
Name [1] 1242 0
Dr Mark Williams
Address [1] 1242 0
Macquarie Centre for Cognitive Sciences (MACCS)
Macquarie University
North Ryde
NSW 2113
Country [1] 1242 0

Ethics approval
Ethics application status
Ethics committee name [1] 258889 0
Human Research Ethics Committee South East Health Douth East Sydney Area Health Service (SESAHS)
Ethics committee address [1] 258889 0
90 Russell Avenue
Dolls Point
NSW 2219
Ethics committee country [1] 258889 0
Date submitted for ethics approval [1] 258889 0
Approval date [1] 258889 0
Ethics approval number [1] 258889 0

Brief summary
An experimental study to investigate the brain effects of laser acupuncture on 4 acupoints found to be highly significant in a pilot study on the use of laser acupuncture in mild to moderate depression- using functional magnetic resonance imaging.
Trial website
Trial related presentations / publications
Quah-Smith I, Sachdev P, Wen W, et al. The brain effects of laser acupuncture in healthy individuals: a functional MRI investigation. PLoS One 2010;5:e12619.
Public notes

Principal investigator
Name 31103 0
Dr Im Quah-Smith
Address 31103 0
Roseville Wellness Group
3/32 Barcoo St
NSW 2069
Country 31103 0
Phone 31103 0
612 94174772
Fax 31103 0
612 94755035
Email 31103 0
Contact person for public queries
Name 14350 0
Dr Dr Im Quah-Smith
Address 14350 0
Roseville Wellness Group
3/32 Barcoo St
NSW 2069
Country 14350 0
Phone 14350 0
612 94174772
Fax 14350 0
612 94755035
Email 14350 0
Contact person for scientific queries
Name 5278 0
Prof Prof Perminder Sachdev
Address 5278 0
Centre for Healthy Brain Aging
Barker Street
Randwick 2031 NSW
Country 5278 0
Phone 5278 0
612 9382 3763
Fax 5278 0
612 9382 3774
Email 5278 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary