ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12626001307392

Ethics application status

Approved

Date submitted

9/10/2026

Date registered

29/10/2026

Date last updated

29/10/2026

Date data sharing statement initially provided

29/10/2026

Type of registration

Prospectively registered

Titles & IDs

Public title

Testing the safety and feasibility of light therapy and electrical brain stimulation in healthy adults and adults with recent concussion

Scientific title

Preliminary safety and feasibility study of photobiomodulation and transcranial electrical stimulation in healthy adults and adults with recent concussion

Additional trial identifiers [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Related trial records

Health condition

Health condition(s) studied:

Concussion (mild traumatic brain injury)

Condition category

Condition code

Neurological

Other neurological disorders

Injuries and Accidents

Other injuries and accidents

Intervention/exposure

Study type

Interventional

Description of the intervention or exposure

Brief name: Home-based photobiomodulation (PBM) combined with transcranial electrical stimulation (tES) for preliminary safety and feasibility testing.

This is a single-arm, open-label safety and feasibility study involving 6 participants (3 healthy adults and 3 adults with recent concussion).

PBM is delivered with the Vielight Neuro RX Duo T5 headset and intranasal applicator, which emit pulsed near-infrared light (810 nm and 1064 nm). Each 25-minute PBM session runs 10 minutes at 10 Hz, a 5-minute rest, then 10 minutes at 40 Hz (50% duty cycle), after which the device switches off automatically. tES is transcranial direct current stimulation delivered with the Soterix Medical 1x1 tDCS mini-CT or BrightStim 2.0 stimulator, using two saline-soaked 5 × 7 cm sponge electrodes (anode over F3, cathode over F8, international 10–20 system), at 2 mA for 25 minutes. Device settings are pre-programmed and cannot be changed by participants.

All participants receive active PBM and active tES together in one 25-minute session per day, no more than once daily, for 7 consecutive days (1 week).

Participants self-administer treatment. At the baseline visit, research team members who have completed protocol-specific training provide each participant with a single, one-to-one, face-to-face training session lasting 2 hours, covering device set-up, placement, operation and safety, followed by supervised practice. Home use starts only once the team is satisfied the participant can use the devices safely. Participants then treat themselves individually. Parameters are fixed, with no individual tailoring. Participants pause or stop treatment and contact the team if side effects occur.

Training takes place at the University of Sydney and treatment at participants' homes. The intervention program consists of the initial training session followed by 7 consecutive days of home treatment.

Adherence is monitored through device session logs, side-effect records and scheduled contact from the research team within 1–3 days of starting treatment, with additional contact if adherence falls below target. Adequate adherence is defined as at least 4 sessions per week on average.

Usual concussion care may continue; concurrent neuromodulation treatment is not permitted.

Intervention code [1]

Treatment: Devices

Description of the comparator or control

Not applicable. This is a single-arm, open-label safety and feasibility study in which all participants receive active photobiomodulation (PBM) combined with active transcranial electrical stimulation (tES). There is no comparator or control group.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Safety of photobiomodulation and transcranial electrical stimulation, assessed as a composite outcome comprising adverse events and adverse device effects.

Timepoint [1]

Throughout the study, from the first treatment session to the final study visit (Week 1, following completion of the 7-day intervention).

Primary outcome [2]

Feasibility of home-based treatment and study procedures, assessed as a composite outcome comprising treatment adherence, treatment tolerability and participant-reported feasibility.

Timepoint [2]

Daily during the 7-day treatment period (Week 1), with overall treatment adherence, tolerability and feasibility assessed at the conclusion of the study.

Secondary outcome [1]

Stress symptoms

Timepoint [1]

Baseline and post-treatment (Week 1, following completion of the 7-day intervention).

Secondary outcome [2]

Sleep quality

Timepoint [2]

Baseline and post-treatment (Week 1, following completion of the 7-day intervention).

Secondary outcome [3]

Processing speed

Timepoint [3]

Baseline (prior to treatment) and post-treatment (Week 1, following completion of the 7-day intervention).

Secondary outcome [4]

Brain electrical activity in the laboratory

Timepoint [4]

Baseline and post-treatment (Week 1, following completion of the 7-day intervention).

Secondary outcome [5]

Brain electrical activity during home treatment

Timepoint [5]

During each home treatment session throughout the 7-day intervention (Week 1).

Secondary outcome [6]

Physical activity level

Timepoint [6]

Baseline and post-treatment (Week 1, following completion of the 7-day intervention).

Secondary outcome [7]

Screen time

Timepoint [7]

Baseline and post-treatment (Week 1, following completion of the 7-day intervention).

Secondary outcome [8]

Work participation

Timepoint [8]

Baseline and post-treatment (Week 1, following completion of the 7-day intervention).

Secondary outcome [9]

Post-concussion symptom severity

Timepoint [9]

Baseline and post-treatment (Week 1, following completion of the 7-day intervention).

Secondary outcome [10]

Study participation

Timepoint [10]

Baseline and post-treatment (Week 1, following completion of the 7-day intervention).

Secondary outcome [11]

Depression symptoms

Timepoint [11]

Baseline and post-treatment (Week 1, following completion of the 7-day intervention).

Secondary outcome [12]

Anxiety symptoms

Timepoint [12]

Baseline and post-treatment (Week 1, following completion of the 7-day intervention).

Eligibility

Key inclusion criteria

Healthy participants:
- Aged 18–40 years
- Able to provide written informed consent
- Able to attend study visits and participate safely and reliably in home-based treatment procedures

Participants with recent concussion:
- Aged 18–40 years
- Clinician-diagnosed concussion or mild traumatic brain injury within the previous 14 days
- Currently experiencing concussion symptoms
- Able to provide written informed consent
- Able to attend study visits and participate safely and reliably in home-based treatment procedures

Minimum age

18 Years

Maximum age

40 Years

Sex

Both males and females

Healthy volunteers

Key exclusion criteria

All participants:
- Evidence of moderate or severe traumatic brain injury
- Structural brain injury or other features requiring urgent or specialist management
- Any concussion red flag symptom: severe or worsening headache, repeated vomiting, seizure or convulsion, reduced or deteriorating level of consciousness, increasing confusion, agitation or unusual behaviour, double vision, neck pain or tenderness, or weakness, numbness or tingling in the arms or legs
- Any contraindication to photobiomodulation or transcranial electrical stimulation, including active brain bleeding, history of seizures or epilepsy, an implanted electrical device or metallic implant in the head, an active scalp lesion, infection or significant skin condition at a device application site, photosensitivity or another condition associated with increased sensitivity to light, or another device-specific contraindication or medical condition that, in the opinion of the overseeing clinician, makes participation unsafe
- Severe or unstable neurological or psychiatric conditions unrelated to concussion that would materially interfere with participation, safety or interpretation of results
- Concurrent neuromodulation treatment during the study period
- Inability to complete home-based treatment safely or reliably
- Pregnant, possibly pregnant, or becoming pregnant during the study

Additional exclusion criterion for healthy participants:
- Any current concussion or other acute neurological condition requiring clinical assessment or management

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

No formal sample size calculation was performed, as this is a preliminary safety and feasibility study. The sample size of 6 participants (3 healthy adults and 3 adults with recent concussion) was selected pragmatically to assess safety, tolerability, feasibility, adherence and early operational issues before commencement of the main randomised controlled trial.

Analyses will be primarily descriptive. Safety outcomes, adverse events, side effects, treatment adherence, feasibility and usability measures will be summarised for all participants. For participants with concussion, pre- and post-intervention symptom and related clinical outcome data will be described to inform interpretation and planning of the subsequent trial. No formal hypothesis testing of treatment efficacy is planned.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/11/2026

Actual

Date of last participant enrolment

Anticipated

1/01/2027

Actual

Date of last data collection

Anticipated

8/01/2027

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

University

Name [1]

The University of Sydney

Address [1]

Country [1]

Australia

Funding source category [2]

Commercial sector/Industry

Name [2]

Vielight Inc.

Address [2]

Country [2]

Canada

Funding source category [3]

Commercial sector/Industry

Name [3]

EMOTIV

Address [3]

Country [3]

United States of America

Primary sponsor type

University

Name

The University of Sydney

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Sydney Human Research Ethics Committee

Ethics committee address [1]

https://www.sydney.edu.au/research/research-integrity-and-ethics.html

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

15/05/2026

Approval date [1]

24/09/2026

Ethics approval number [1]

2026/HE000673

Summary

Brief summary

This study will assess the safety and practicality of combining two non-invasive brain treatments in healthy adults and adults recovering from a recent concussion. Photobiomodulation uses a headset and a small nasal applicator to deliver near-infrared light, while transcranial electrical stimulation delivers a weak electrical current through two pads on the scalp. Six adults aged 18 to 40 (three healthy adults and three with a recent concussion) will use both treatments together at home for 25 minutes per day over one week. Researchers will assess side effects, treatment tolerability, adherence and participants' ability to use the devices safely at home, alongside exploratory measures of concussion symptoms, mood, sleep, cognitive performance and brain activity. The findings will help determine whether the combined treatment is safe and feasible and inform the subsequent randomised controlled trial.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Ian Johnston

Address

School of Psychology, Brennan MacCallum Building (A18), Manning Road, The University of Sydney, Camperdown NSW 2050, Australia

Country

Australia

Phone

+61 416 981 204

Fax

[email protected]

Contact person for public queries

Name

Madelaine Pankhurst

Address

School of Psychology, Brennan MacCallum Building (A18), Manning Road, The University of Sydney, Camperdown NSW 2050, Australia

Country

Australia

Phone

+61 452 507 693

Fax

[email protected]

Contact person for scientific queries

Name

Madelaine Pankhurst

Address

School of Psychology, Brennan MacCallum Building (A18), Manning Road, The University of Sydney, Camperdown NSW 2050, Australia

Country

Australia

Phone

+61 452 507 693

Fax

[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 review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• 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

What types of analyses could be done with individual participant data?

• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Studies testing whether findings can be repeated or confirmed

When can requests for individual participant data be made (start and end dates)?

From:
After publication of main results
To:
A finite period of: 5 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?

Yes: Only data from participants who consented to future use of their de-identified data will be shared, and only for research related to concussion, neuromodulation or closely related areas, in line with participant consent.

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.

Trial Review

Documents added manually

Documents added automatically