Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000368033
Ethics application status
Approved
Date submitted
28/04/2010
Date registered
10/05/2010
Date last updated
18/11/2013
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
NIL
Universal Trial Number (UTN)
Trial acronym
MRIHS
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
Depression

Intervention/exposure
Study type
Interventional
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
Placebo

Outcomes
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.

Eligibility
Key inclusion criteria
1. Healthy subject
2. Right handed
3. Able to undergo magnetic resonance imaging
scan.
4. Able to provide informed consent.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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
Treatment
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
NIL
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2005
Actual
5/08/2005
Date of last participant enrolment
Anticipated
8/12/2005
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256882 0
Hospital
Name [1] 256882 0
Prince of Wales Hospital
Country [1] 256882 0
Australia
Primary sponsor type
Hospital
Name
Prince of Wales Hospital
Address
Prof Perminder Sachdev
Neuropsychiatric Institute NPI
Prince of Wales Hospital PoWH
Barker Street
Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 256154 0
None
Name [1] 256154 0
Address [1] 256154 0
Country [1] 256154 0
Other collaborator category [1] 1242 0
Individual
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
Australia

Ethics approval
Ethics application status
Approved
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
Ethics committee country [1] 258889 0
Australia
Date submitted for ethics approval [1] 258889 0
Approval date [1] 258889 0
10/05/2005
Ethics approval number [1] 258889 0
05-073

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31103 0
Dr Im Quah-Smith
Address 31103 0
Roseville Wellness Group
3/32 Barcoo St
Roseville
NSW 2069
Country 31103 0
Australia
Phone 31103 0
612 94174772
Fax 31103 0
612 94755035
Email 31103 0
[email protected]
Contact person for public queries
Name 14350 0
Dr Im Quah-Smith
Address 14350 0
Roseville Wellness Group
3/32 Barcoo St
Roseville
NSW 2069
Country 14350 0
Australia
Phone 14350 0
612 94174772
Fax 14350 0
612 94755035
Email 14350 0
[email protected]
Contact person for scientific queries
Name 5278 0
Prof Perminder Sachdev
Address 5278 0
Centre for Healthy Brain Aging
CHeBA
Barker Street
Randwick 2031 NSW
Country 5278 0
Australia
Phone 5278 0
612 9382 3763
Fax 5278 0
612 9382 3774
Email 5278 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.