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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?
Scientific title
TDCS on the effectiveness of Laser Acupuncture on the corticospinal excitability and sensorimotor function in healthy participants
Secondary ID [1] 314073 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
brain function 336834 0
sensorimotor function 336981 0
Condition category
Condition code
Alternative and Complementary Medicine 333319 333319 0 0
Other alternative and complementary medicine
Neurological 333443 333443 0 0
Studies of the normal brain and nervous system
Physical Medicine / Rehabilitation 333444 333444 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 330661 0
Treatment: Devices
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.
Control group
Placebo

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.
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).
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.
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).
Secondary outcome [1] 445418 0
Corti cortical excitability (CCE)
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)

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.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

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)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
3/02/2025
Date of last participant enrolment
Anticipated
1/12/2025
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
20
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 318580 0
University
Name [1] 318580 0
Monash Univeristy
Country [1] 318580 0
Australia
Primary sponsor type
Individual
Name
Renming Liu (Monash University)
Address
Country
Australia
Secondary sponsor category [1] 320991 0
None
Name [1] 320991 0
Address [1] 320991 0
Country [1] 320991 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317178 0
Monash Health Human Research Ethics Committee A
Ethics committee address [1] 317178 0
Ethics committee country [1] 317178 0
Australia
Date submitted for ethics approval [1] 317178 0
01/12/2023
Approval date [1] 317178 0
06/03/2024
Ethics approval number [1] 317178 0
41104

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

Contacts
Principal investigator
Name 140258 0
Dr Renming.Liu
Address 140258 0
Monash University – Peninsula Campus School of Primary and Allied Health Care Building A, 47 Moorooduc Highway Frankston VIC 3199 Australia
Country 140258 0
Australia
Phone 140258 0
+61 426227757
Fax 140258 0
Email 140258 0
[email protected]
Contact person for public queries
Name 140259 0
Renming.Liu
Address 140259 0
Monash University – Peninsula Campus School of Primary and Allied Health Care Building A, 47 Moorooduc Highway Frankston VIC 3199 Australia
Country 140259 0
Australia
Phone 140259 0
+61 426227757
Fax 140259 0
Email 140259 0
[email protected]
Contact person for scientific queries
Name 140260 0
Renming.Liu
Address 140260 0
Monash University – Peninsula Campus School of Primary and Allied Health Care Building A, 47 Moorooduc Highway Frankston VIC 3199 Australia
Country 140260 0
Australia
Phone 140260 0
+61 426227757
Fax 140260 0
Email 140260 0
[email protected]

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24580Ethical approval    ethics approval .pdf



Results publications and other study-related documents

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