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Trial registered on ANZCTR


Registration number
ACTRN12624001446550
Ethics application status
Approved
Date submitted
8/11/2024
Date registered
12/12/2024
Date last updated
12/12/2024
Date data sharing statement initially provided
12/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Low-level light therapy for people with chronic fatigue
Scientific title
Comparing pulsed and continuous transcranial photobiomodulation to placebo in people with chronic fatigue – a pilot double blinded randomised placebo-controlled trial
Secondary ID [1] 313418 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Fatigue 335695 0
Condition category
Condition code
Other 332258 332258 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Transcranial photobiomodulation (tPBM) will be administered five times per week (20 minutes/session) for a total of three weeks (i.e., a total of 15 sessions) using the Neuradient 1070 light-emitting diodes helmet (Neuronic Devices Ltd, Ireland).
The active groups will receive either continuous (glow) or 40Hz pulsed tPBM at a wavelength of 1070±50nm.
Participants will be seated in a comfortable chair for the duration of the tPBm sessions.
Sessions will take place at an urban public hospital and be carried out by trained clinical and/or academic staff. Allocation to an active or placebo group will be done by random code. Adherence to intervention will be assessed by attendance at sessions.
Intervention code [1] 329921 0
Treatment: Devices
Comparator / control treatment
An identical system will be used, but no photons are emitted, thus no tPBM takes place.
Control group
Placebo

Outcomes
Primary outcome [1] 339830 0
Changes in fatigue
Timepoint [1] 339830 0
Screening (T0), baseline (T1), after each week of intervention (T2, T3, T4), and at one-week (T5) and one-month post-completion of intervention (T6)
Secondary outcome [1] 441566 0
Resting energy expenditure
Timepoint [1] 441566 0
Baseline (T1), and at one-week (T5) and one-month post-completion of intervention (T6)
Secondary outcome [2] 441567 0
Cognition
Timepoint [2] 441567 0
Baseline (T1), and at one-week (T5) and one-month post-completion of intervention (T6)
Secondary outcome [3] 441568 0
Resting state electroencephalography (sensor level)
Timepoint [3] 441568 0
Baseline (T1), and at one-week (T5) and one-month post-completion of intervention (T6)
Secondary outcome [4] 441925 0
Sleep
Timepoint [4] 441925 0
Baseline (T1), and at one-week (T5) and one-month post-completion of intervention (T6)
Secondary outcome [5] 441928 0
Composite psychological measures
Timepoint [5] 441928 0
Baseline (T1), and at one-week (T5) and one-month post-completion of intervention (T6)
Secondary outcome [6] 441929 0
Patient Global Impression of Change (PGIC)
Timepoint [6] 441929 0
Baseline (T1), and at one-week (T5) and one-month post-completion of intervention (T6)
Secondary outcome [7] 441930 0
Resting state electroencephalography (source level)
Timepoint [7] 441930 0
Baseline (T1), and at one-week (T5) and one-month post-completion of intervention (T6)
Secondary outcome [8] 441931 0
Resting state electroencephalography (Region of Interest)
Timepoint [8] 441931 0
Baseline (T1), and at one-week (T5) and one-month post-completion of intervention (T6)
Secondary outcome [9] 441932 0
Safety measures
Timepoint [9] 441932 0
Actively monitored during each intervention session and passively until one-month post-completion of intervention.

Eligibility
Key inclusion criteria
Participants with a chronic fatigue, irrespective of the cause, will be eligible to participate.


Participants will need to:
- have fatigue that occurs every day for at least 6 months,
- have a score of at least 36 on the fatigue severity scale in the past 7 days,
- be capable of understanding and signing an informed consent form.
- aged between 18 to 70 years on the day of the consent.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants who meet any of the following conditions will be excluded:
- Cognitive (e.g. Alzheimer’s disease, dementia) and psychiatric disorders
- Underwent any surgery requiring general anaesthetic in the past six months.
- Broken/fractured/torn any bones or ligaments within the past six months.
- Altered medications in the past one month.
- Made major dietary alterations in the past one month.
- History of epilepsy, seizures, substance abuse disorders
- Electronic implants (e.g. pacemaker) or other metal objects in the brain
- Any proliferative disease (e.g. cancer)
- Any surface bacterial/fungal infection (e.g. blepharitis)
- Any acute or uncontrolled medical conditions
- Pregnant or six-months post-partum

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 (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/01/2025
Actual
Date of last participant enrolment
Anticipated
13/10/2025
Actual
Date of last data collection
Anticipated
28/11/2025
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment outside Australia
Country [1] 26710 0
New Zealand
State/province [1] 26710 0

Funding & Sponsors
Funding source category [1] 317786 0
University
Name [1] 317786 0
University of Otago
Country [1] 317786 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Country
New Zealand
Secondary sponsor category [1] 320105 0
None
Name [1] 320105 0
Address [1] 320105 0
Country [1] 320105 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316469 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 316469 0
Ethics committee country [1] 316469 0
New Zealand
Date submitted for ethics approval [1] 316469 0
19/09/2024
Approval date [1] 316469 0
25/10/2024
Ethics approval number [1] 316469 0

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

Contacts
Principal investigator
Name 137990 0
Prof Dirk De Ridder
Address 137990 0
Department of Surgical Sciences, University of Otago, 201 Great King Street, Dunedin 9016
Country 137990 0
New Zealand
Phone 137990 0
+64 275601144
Fax 137990 0
Email 137990 0
dirk.deridder@otago.ac.nz
Contact person for public queries
Name 137991 0
Dr Divya Adhia
Address 137991 0
Department of Surgical Sciences, University of Otago, 201 Great King Street, Central Dunedin, Dunedin 9016
Country 137991 0
New Zealand
Phone 137991 0
+64 211167594
Fax 137991 0
Email 137991 0
diyva.adhia@otago.ac.nz
Contact person for scientific queries
Name 137992 0
Dr Divya Adhia
Address 137992 0
Department of Surgical Sciences, University of Otago, 201 Great King Street, Dunedin 9016
Country 137992 0
New Zealand
Phone 137992 0
+64 3 470 9337
Fax 137992 0
Email 137992 0
diyva.adhia@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.