Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12625000291482
Ethics application status
Approved
Date submitted
30/03/2025
Date registered
14/04/2025
Date last updated
14/04/2025
Date data sharing statement initially provided
14/04/2025
Type of registration
Retrospectively registered
Titles & IDs
Public title
Can brain stimulation enhance the effects of laser acupuncture on movement and brain activity?
Query!
Scientific title
TDCS on the effectiveness of Laser Acupuncture on the corticospinal excitability and sensorimotor function in healthy participants
Query!
Secondary ID [1]
314073
0
None
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
sensorimotor function
336981
0
Query!
brain function
336834
0
Query!
Condition category
Condition code
Neurological
333443
333443
0
0
Query!
Studies of the normal brain and nervous system
Query!
Physical Medicine / Rehabilitation
333444
333444
0
0
Query!
Other physical medicine / rehabilitation
Query!
Alternative and Complementary Medicine
333319
333319
0
0
Query!
Other alternative and complementary medicine
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
This study involves the combined use of laser acupuncture and transcranial direct current stimulation (tDCS) to investigate their effects on brain excitability and motor threshold.
Laser Acupuncture Therapy
Laser acupuncture is a non-invasive therapeutic method that applies low-level laser therapy (LLLT) to acupuncture points to stimulate physiological responses. In this study, a low-level laser device will be used to irradiate the LI4 (Hegu) and LI11 (Quchi) acupoints bilaterally. The parameters for laser acupuncture are:
Wavelength: 808 nm
Power output: 100 mW
Energy density: 4 J/cm² per point
Mode: Continuous wave
Duration: 5 minutes
Transcranial Direct Current Stimulation (tDCS)
tDCS is a non-invasive neuromodulation technique that delivers a constant, low-intensity electrical current to the scalp to modulate neuronal excitability. In this study, anodal tDCS will be applied over the primary motor cortex (M1), with the cathode placed over the contralateral supraorbital region. The stimulation parameters are:
Intensity: 2 mA
Duration: 20 minutes
Electrode size: 5x7 cm (35 cm²)
Current density: 0.043 mA/cm²
Timing and Delivery:
Laser acupuncture and tDCS will be administered simultaneously, with both interventions starting and ending at the same time.
Frequency and Duration:
Each participant will receive one session per condition, and there are three conditions in total (e.g., laser acupuncture alone, tDCS alone, and combined intervention), following a crossover design. Each session lasts approximately 120 minutes including setup and assessments. A washout period of at least 48 hours will be implemented between sessions to minimize carryover effects.
Personnel:
All interventions will be administered by a trained acupuncturist with experience in laser therapy, and a trained neurostimulation technician for tDCS procedures.
Setting:
All sessions will take place in a controlled university research laboratory at Monash University Peninsula Campus.
Adherence and Fidelity Monitoring:
Intervention adherence will be monitored by trained research staff using standardized treatment checklists. Fidelity to the protocol will be ensured through direct observation and regular supervision. Equipment logs will be maintained to record parameters and duration for each session.
Query!
Intervention code [1]
330661
0
Treatment: Devices
Query!
Comparator / control treatment
The control condition involves sham laser acupuncture, which is a placebo procedure designed to replicate the experience of real laser acupuncture without emitting active laser light. The same laser device will be applied to the same acupuncture points (LI4 and LI11 bilaterally), but the laser output will be disabled. The device will remain in contact with the skin for the same duration (5 minutes in total) to ensure the procedure is indistinguishable from the active condition in appearance and sensation.
No tDCS Use in Control Condition:
Each participant will undergo all intervention and control conditions with a minimum 48-hour washout period between sessions.
Query!
Control group
Placebo
Query!
Outcomes
Primary outcome [1]
340906
0
Outcome Name: Corticospinal excitability Timepoint(s): Immediately before and after each intervention session (i.e., pre- and post-session on Week 1 Day 1, Week 1 Day 4, Week 2 Day 1, and Week 2 Day 4) Description: Corticospinal excitability will be assessed using single-pulse transcranial magnetic stimulation (TMS) to measure resting motor threshold (RMT) and motor-evoked potential (MEP) amplitude of the target muscle (e.g., first dorsal interosseous). All assessments will be conducted in a controlled laboratory setting using standardized TMS protocols.
Query!
Assessment method [1]
340906
0
Transcranial Magnetic Stimulation (TMS) Corticospinal excitability will be assessed using TMS by delivering single-pulse stimulation over the primary motor cortex. Resting motor threshold (RMT) and motor-evoked potentials (MEPs) will be recorded from surface electrodes placed on the first dorsal interosseous (FDI) muscle. Measurements will be taken immediately before and after each intervention session.
Query!
Timepoint [1]
340906
0
Each intervention session includes a pre-treatment assessment, the intervention, and an immediate post-treatment assessment. A 48-hour washout period is applied between sessions. The primary timepoints are immediately before and after each intervention session (i.e., pre- and post-intervention assessments for all four conditions, each separated by a 48-hour washout period).
Query!
Primary outcome [2]
341016
0
Reaction time Timepoint(s): Immediately before and after each intervention session (i.e., pre- and post-session on Week 1 Day 1, Week 1 Day 4, Week 2 Day 1, and Week 2 Day 4) Description: Reaction time will be measured using a computerized simple reaction time test. Participants will be instructed to respond as quickly as possible to a visual stimulus presented on a screen. The average response time across multiple trials will be recorded for analysis.
Query!
Assessment method [2]
341016
0
PsyToolKit Reaction time will be assessed using a computerized visual reaction time task delivered via PsyToolKit. Participants will be instructed to respond to visual stimuli as quickly as possible by pressing a key. The average response time will be calculated across multiple trials before and after each intervention session.
Query!
Timepoint [2]
341016
0
Each intervention session includes a pre-treatment assessment, the intervention, and an immediate post-treatment assessment. A 48-hour washout period is applied between sessions. The primary timepoints are immediately before and after each intervention session (i.e., pre- and post-intervention assessments for all four conditions, each separated by a 48-hour washout period).
Query!
Secondary outcome [1]
445418
0
Corti cortical excitability (CCE)
Query!
Assessment method [1]
445418
0
TMS
Query!
Timepoint [1]
445418
0
Immediately before and after each intervention session (i.e., pre- and post-session on Week 1 Day 1, Week 1 Day 4, Week 2 Day 1, and Week 2 Day 4)
Query!
Eligibility
Key inclusion criteria
All healthy participants shoulde be right-handed and
had no known neurological or psychological symptoms.
Participants are also not taking any medications
(including caffeine) that could influence corticospinal excitability.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
40
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
The following conditions or circumstances would make you ineligible to participate in this study.
• Psychiatric or neurological illnesses (including brain injury and cranial surgery).
• History of seizure, epilepsy, heart convulsion, head injury, or having epilepsy or seizures in first-degree relatives.
• Presence of any metal in the head (excluding the mouth), metallic particles in the eye, implanted cardiac
pacemaker, or intra-cardiac lines.
• Frequent or severe headaches, or a history of migraines.
• Any implanted neuro-stimulators, surgical clips, medical pumps, or implanted electrical biomedical devices (such as
defibrillators or acoustic devices).
• Pregnancy.
• Current use of medications, excessive caffeine consumption, or energy drinks.
• Sleep deprivation.
• Inability to speak, read, or write in English.
• Any conditions that affect nerve conduction velocity (NCV), including carpal tunnel syndrome or nerve grafts.
• Presence of nerve entrapment symptoms, such as numbness, pins and needles sensation, swelling, or pain in the
upper extremities (particularly at night).
• Abnormal skin conditions in the upper extremities for otherwise healthy individuals.
• Any skin conditions on the scalp.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Crossover
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Efficacy
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
3/02/2025
Query!
Date of last participant enrolment
Anticipated
1/12/2025
Query!
Actual
Query!
Date of last data collection
Anticipated
1/12/2025
Query!
Actual
Query!
Sample size
Target
20
Query!
Accrual to date
1
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
VIC
Query!
Funding & Sponsors
Funding source category [1]
318580
0
University
Query!
Name [1]
318580
0
Monash Univeristy
Query!
Address [1]
318580
0
Query!
Country [1]
318580
0
Australia
Query!
Primary sponsor type
Individual
Query!
Name
Renming Liu (Monash University)
Query!
Address
Query!
Country
Australia
Query!
Secondary sponsor category [1]
320991
0
None
Query!
Name [1]
320991
0
Query!
Address [1]
320991
0
Query!
Country [1]
320991
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
317178
0
Monash Health Human Research Ethics Committee A
Query!
Ethics committee address [1]
317178
0
https://monashhealth.org/research/resources/resource-library/
Query!
Ethics committee country [1]
317178
0
Australia
Query!
Date submitted for ethics approval [1]
317178
0
01/12/2023
Query!
Approval date [1]
317178
0
06/03/2024
Query!
Ethics approval number [1]
317178
0
41104
Query!
Summary
Brief summary
This study aims to investigate how laser acupuncture therapy works in combination with a type of brain stimulation called transcranial direct current stimulation (tDCS), which gently increases brain activity. Both techniques are non-invasive and may help improve muscle control. The research will be conducted in healthy adults using standardized testing before and after treatment. It is hypothesised that combining tDCS with laser acupuncture will enhance brain excitability and motor function more effectively than either technique alone.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
140258
0
Dr Renming.Liu
Query!
Address
140258
0
Monash University – Peninsula Campus School of Primary and Allied Health Care Building A, 47 Moorooduc Highway Frankston VIC 3199 Australia
Query!
Country
140258
0
Australia
Query!
Phone
140258
0
+61 426227757
Query!
Fax
140258
0
Query!
Email
140258
0
[email protected]
Query!
Contact person for public queries
Name
140259
0
Renming.Liu
Query!
Address
140259
0
Monash University – Peninsula Campus School of Primary and Allied Health Care Building A, 47 Moorooduc Highway Frankston VIC 3199 Australia
Query!
Country
140259
0
Australia
Query!
Phone
140259
0
+61 426227757
Query!
Fax
140259
0
Query!
Email
140259
0
[email protected]
Query!
Contact person for scientific queries
Name
140260
0
Renming.Liu
Query!
Address
140260
0
Monash University – Peninsula Campus School of Primary and Allied Health Care Building A, 47 Moorooduc Highway Frankston VIC 3199 Australia
Query!
Country
140260
0
Australia
Query!
Phone
140260
0
+61 426227757
Query!
Fax
140260
0
Query!
Email
140260
0
[email protected]
Query!
Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
•
Researchers
Conditions for requesting access:
•
Yes, conditions apply:
•
Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
•
De-identified individual participant data:
•
Published results
•
Primary outcome(s)
What types of analyses could be done with individual participant data?
•
Studies exploring new research questions
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
A finite period of:
1
years
Where can requests to access individual participant data be made, or data be obtained directly?
•
Email of trial custodian, sponsor or committee:
[email protected]
Are there extra considerations when requesting access to individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Type
Citation
Link
Email
Other Details
Attachment
Ethical approval
ethics approval .pdf
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.
Download to PDF