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.
A database of clinical trials and their results from Australia, New Zealand, and other countries.
account_circle
Log in
to register or update your trial
search
Search for trials
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
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
Query!
Scientific title
Comparing pulsed and continuous transcranial photobiomodulation to placebo in people with chronic fatigue – a pilot double blinded randomised placebo-controlled trial
Query!
Secondary ID [1]
313418
0
Nil known
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Chronic Fatigue
335695
0
Query!
Condition category
Condition code
Other
332258
332258
0
0
Query!
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
329921
0
Treatment: Devices
Query!
Comparator / control treatment
An identical system will be used, but no photons are emitted, thus no tPBM takes place.
Query!
Control group
Placebo
Query!
Outcomes
Primary outcome [1]
339830
0
Changes in fatigue
Query!
Assessment method [1]
339830
0
The fatigue severity scale (FSS) will be used to measure the participant’s level of fatigue. The FSS questionnaire contains nine statements graded on a Likert scale of 1 to 7 that rate the severity of fatigue symptoms during the past week. A score <36 suggests no fatigue, whereas higher scores indicate higher levels of fatigue. The MCID of FSS is 4.28
Query!
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)
Query!
Secondary outcome [1]
441566
0
Resting energy expenditure
Query!
Assessment method [1]
441566
0
Resting energy expenditure will be measured using the Fitmate Nutritional Assessment equipment (Cosmed Pulmonary Function Equipment). Resting Metabolic Rate (RMR / REE) and Oxygen Consumption (VO2) will be measured while participant is resting and comfortably seated in a chair. The Fitmate system measures exhaled gas levels (indirect calorimetry), which assesses oxygen consumption to estimate energy expenditure.
Query!
Timepoint [1]
441566
0
Baseline (T1), and at one-week (T5) and one-month post-completion of intervention (T6)
Query!
Secondary outcome [2]
441567
0
Cognition
Query!
Assessment method [2]
441567
0
Stroop task and Trail making tests will be used to evaluate the effect of tPBM on executive functioning and general attention respectively. These tests have been used in previous PBM studies and are shown to be sensitive to changes resulting from PBM paradigms.
Query!
Timepoint [2]
441567
0
Baseline (T1), and at one-week (T5) and one-month post-completion of intervention (T6)
Query!
Secondary outcome [3]
441568
0
Resting state electroencephalography (sensor level)
Query!
Assessment method [3]
441568
0
Composite sensor level analysis: - Global alpha and gamma connectivity - Average Power spectral density will be calculated across all 32 electrodes and will be used for analysis
Query!
Timepoint [3]
441568
0
Baseline (T1), and at one-week (T5) and one-month post-completion of intervention (T6)
Query!
Secondary outcome [4]
441925
0
Sleep
Query!
Assessment method [4]
441925
0
Medical Outcomes Study-Sleep Scale (MOS-Sleep) is a valid, reliable, and commonly used self-reported 12-item instrument for assessing key constructs of sleep quality and quantity. MOS-Sleep will be administered to participants to assess the effect of the treatment on participant’s quality of sleep and its influence on the outcome measures.
Query!
Timepoint [4]
441925
0
Baseline (T1), and at one-week (T5) and one-month post-completion of intervention (T6)
Query!
Secondary outcome [5]
441928
0
Composite psychological measures
Query!
Assessment method [5]
441928
0
Depression, Anxiety, and Stress Scale (DASS) will be used to measure those three psychological constructs: depression, anxiety, and stress.
Query!
Timepoint [5]
441928
0
Baseline (T1), and at one-week (T5) and one-month post-completion of intervention (T6)
Query!
Secondary outcome [6]
441929
0
Patient Global Impression of Change (PGIC)
Query!
Assessment method [6]
441929
0
PGIC scale will be used to capture patient's belief about the efficacy of treatment. PGIC is a 7-point scale depicting a patient's rating of overall improvement. Patients rate their change as “very much improved,” “much improved,” “minimally improved,” “no change,” “minimally worse,” “much worse,” or “very much worse.”
Query!
Timepoint [6]
441929
0
Baseline (T1), and at one-week (T5) and one-month post-completion of intervention (T6)
Query!
Secondary outcome [7]
441930
0
Resting state electroencephalography (source level)
Query!
Assessment method [7]
441930
0
Composite source level analysis: Standardized low-resolution brain electromagnetic tomography (sLORETA) will be used to estimate the intracerebral electrical sources that generates the scalp-recorded activity in the alpha and gamma frequency band.
Query!
Timepoint [7]
441930
0
Baseline (T1), and at one-week (T5) and one-month post-completion of intervention (T6)
Query!
Secondary outcome [8]
441931
0
Resting state electroencephalography (Region of Interest)
Query!
Assessment method [8]
441931
0
Composite region of interest analysis will be used to calculate and compare the log transformed current density changes in alpha and gamma bands at the pregenual anterior cingulate cortex (pgACC). Previous research has implicated the pgACC with the pathophysiology of chronic fatigue.
Query!
Timepoint [8]
441931
0
Baseline (T1), and at one-week (T5) and one-month post-completion of intervention (T6)
Query!
Secondary outcome [9]
441932
0
Safety measures
Query!
Assessment method [9]
441932
0
Although photobiomodulation is a safe technique, any adverse effects (e.g., headache, pain flare-ups) that likely have a causal relationship with the intervention will be recorded by the treating researcher at each treatment session. The following variables will be recorded: -Qualitative description of each symptom -Intensity of each symptom, measured using a Likert scale ranging from 0 (none) to 10 (extreme) -Perceived relation of the symptom to the tPBM treatment, measured on a scale ranging from 1 (unrelated) to 5 (strongly related) -Duration of each symptom and the time taken for resolution of each symptom, expressed in minutes -Any drop-outs due to adverse effects will also be recorded
Query!
Timepoint [9]
441932
0
Actively monitored during each intervention session and passively until one-month post-completion of intervention.
Query!
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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
70
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
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 (i.e. computerised sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
Query!
Query!
Query!
Query!
Intervention assignment
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Safety/efficacy
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Date of first participant enrolment
Anticipated
6/01/2025
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
13/10/2025
Query!
Actual
Query!
Date of last data collection
Anticipated
28/11/2025
Query!
Actual
Query!
Sample size
Target
45
Query!
Accrual to date
Query!
Final
Query!
Recruitment outside Australia
Country [1]
26710
0
New Zealand
Query!
State/province [1]
26710
0
Query!
Funding & Sponsors
Funding source category [1]
317786
0
University
Query!
Name [1]
317786
0
University of Otago
Query!
Address [1]
317786
0
Query!
Country [1]
317786
0
New Zealand
Query!
Primary sponsor type
University
Query!
Name
University of Otago
Query!
Address
Query!
Country
New Zealand
Query!
Secondary sponsor category [1]
320105
0
None
Query!
Name [1]
320105
0
Query!
Address [1]
320105
0
Query!
Country [1]
320105
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
316469
0
Southern Health and Disability Ethics Committee
Query!
Ethics committee address [1]
316469
0
https://ethics.health.govt.nz/about/southern-health-and-disability-ethics-committee/
Query!
Ethics committee country [1]
316469
0
New Zealand
Query!
Date submitted for ethics approval [1]
316469
0
19/09/2024
Query!
Approval date [1]
316469
0
25/10/2024
Query!
Ethics approval number [1]
316469
0
Query!
Summary
Brief summary
The purpose of this study is to evaluate the safety and to explore the effect of a photobiomodulation technique on fatigue severity in individuals with a diagnosis of chronic fatigue. This study will involve photobiomodulation applied to the whole brain in individuals with chronic fatigue. The results obtained from this study will help us to develop new treatments for improving fatigue severity in individuals with chronic fatigue. We hypothesise that, compared to a placebo treatment, tPBM will improve fatigue, energy levels, and thinking skills in people with chronic fatigue. We also predict improvements in brain function linked to better overall health outcomes.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
137990
0
Prof Dirk De Ridder
Query!
Address
137990
0
Department of Surgical Sciences, University of Otago, 201 Great King Street, Dunedin 9016
Query!
Country
137990
0
New Zealand
Query!
Phone
137990
0
+64 275601144
Query!
Fax
137990
0
Query!
Email
137990
0
[email protected]
Query!
Contact person for public queries
Name
137991
0
Dr Divya Adhia
Query!
Address
137991
0
Department of Surgical Sciences, University of Otago, 201 Great King Street, Central Dunedin, Dunedin 9016
Query!
Country
137991
0
New Zealand
Query!
Phone
137991
0
+64 211167594
Query!
Fax
137991
0
Query!
Email
137991
0
[email protected]
Query!
Contact person for scientific queries
Name
137992
0
Dr Divya Adhia
Query!
Address
137992
0
Department of Surgical Sciences, University of Otago, 201 Great King Street, Dunedin 9016
Query!
Country
137992
0
New Zealand
Query!
Phone
137992
0
+64 3 470 9337
Query!
Fax
137992
0
Query!
Email
137992
0
[email protected]
Query!
Data sharing statement
Will the study consider sharing individual participant data?
No
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.
Download to PDF