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Trial registered on ANZCTR


Registration number
ACTRN12623001040651
Ethics application status
Approved
Date submitted
7/09/2023
Date registered
26/09/2023
Date last updated
18/10/2023
Date data sharing statement initially provided
26/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
An Open Label Pilot Study of Photo-Biomodulation Therapy.
Scientific title
An Open Label Pilot Study of Photo-Biomodulation Therapy in Healthy Adults aged 50 to 70years.
Secondary ID [1] 310560 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive impairment 331394 0
Condition category
Condition code
Neurological 328139 328139 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An open label pilot study of photo-biomodulation therapy (PBMT).

The main goal of the study is to examine the safety and tolerability of transcranial PBMT with a helmet style of device for healthy participants aged 50-70 years. Participants will be on their “treatment as usual” regimen which implies that they will continue to take all their regular medications. The PBMT treatment will be adjunctive.

The proposed open-label trial will comprise of a single treatment arm, whereby healthy participants aged 50 to 70 years (N=30) will receive PBMT treatment twice per week for 12 weeks. For each session, the participant will be instructed to sit upright in a chair with their eyes open whilst wearing the helmet device to receive 20 minutes (exposure time) of photo-biomodulation treatment with pulse mode setting, square wave time 20Hz/min and light intensity of 20%. PBMT treatments will occur twice a week with at least 2 days apart in between at the Thompson Institute. The PBMT session will be performed by trained PBMT technicians and researchers. All participants will be informed that they will receive PBMT treatment. Neuropsychological and self-report assessments along with Magnetic Resonance Imaging (MRI) and Electroencephalogram (EEG) will occur at entry into the study (week 0) and after the treatment period (week 12). If a participant is unable to attend or misses a treatment session, details of the deviation, including reason for failure to attend, will be recorded in the source documentation. If participants miss more than two weeks of PBMT treatment, they will be excluded from the study.
Intervention code [1] 326957 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336016 0
Participant safety and tolerability (number and severity of adverse events). Adverse events will be defined by any unfavourable or unintended symptoms or distress associated with PBMT which may or may not be related to the treatment (e.g. dizziness, nausea, headache, dry mouth, discomfort, emotional distress). Adverse events will be recorded and categorised according to the Common Terminology Criteria for Adverse Events (CTCAE5). These will be recorded through weekly questionnaires that participants fill out with a yes/no response followed by an open response questionnaire to detail the event if one has occurred.
Timepoint [1] 336016 0
Weekly questionnaires during the 12weeks of treatment.
Primary outcome [2] 336017 0
Program completion (actual PBMT therapy completed). Participants will be assessed as having completed the program if they have attended at least 75% of the planned therapy over the coarse of the 12 weeks. This will be recorded via an attendance sheet where the researchers indicate if they have completed their therapy for that day.
Timepoint [2] 336017 0
Assessed at 1 week post-completion of PBMT treatment program.
Secondary outcome [1] 426487 0
Change in cognitive function as assessed by the Cambridge Neuropsychological Test Automated Battery (CANTAB) assessment
Timepoint [1] 426487 0
1. Assessed at baseline.
2. Assessed at 1 week post-completion of PBMT treatment program.
Secondary outcome [2] 426488 0
Change in neuroanatomical structure as assessed by Magnetic Resonance Imaging (MRI)
Timepoint [2] 426488 0
1. Assessed at baseline.
2. Assessed at 1 week post-completion of PBMT treatment program.
Secondary outcome [3] 426489 0
Change in depression results as assessed by the self-report Geriatric Depression Scale,
Timepoint [3] 426489 0
1. Assessed at baseline.
2. Assessed at 1 week post-completion of PBMT treatment program.
Secondary outcome [4] 426490 0
Change in brain activity as assessed by the Electroencephalography (EEG)
Timepoint [4] 426490 0
1. Assessed at baseline.
2. Assessed at 1 week post-completion of PBMT treatment program.
Secondary outcome [5] 426491 0
Change in sleep functioning as measured by Pittsburgh Sleep Quality Index
Timepoint [5] 426491 0
1. Assessed at baseline.
2. Assessed at 1 week post-completion of PBMT treatment program.
Secondary outcome [6] 426492 0
Change in self-reported memory functioning as assessed by Everyday Memory Questionnaire
Timepoint [6] 426492 0
1. Assessed at baseline.
2. Assessed at 1 week post-completion of PBMT treatment program.
Secondary outcome [7] 426905 0
Change in dynamic brain activity as assessed by Magnetic Resonance Imaging (MRI)
Timepoint [7] 426905 0
1. Assessed at baseline.
2. Assessed at 1 week post-completion of PBMT treatment program.
Secondary outcome [8] 426906 0
Change in neurochemistry as assessed by Magnetic Resonance Imaging (MRI)
Timepoint [8] 426906 0
1. Assessed at baseline.
2. Assessed at 1 week post-completion of PBMT treatment program.
Secondary outcome [9] 426907 0
Change in anxiety results as assessed by the self-report Geriatric Anxiety Inventory,
Timepoint [9] 426907 0
1. Assessed at baseline.
2. Assessed at 1 week post-completion of PBMT treatment program.
Secondary outcome [10] 426908 0
Change in alcohol use as assessed by the self-report Audit-C questionnaire.
Timepoint [10] 426908 0
1. Assessed at baseline.
2. Assessed at 1 week post-completion of PBMT treatment program.
Secondary outcome [11] 426909 0
Change in quality of life results as assessed by the self-report Assessment of Quality of Life questionnaire.
Timepoint [11] 426909 0
1. Assessed at baseline.
2. Assessed at 1 week post-completion of PBMT treatment program.

Eligibility
Key inclusion criteria
- Persons aged 50-70 years.
- Participants must be able to understand Research Project Information Sheet (RPIS) and provide written informed consent on the Participant Informed Consent Form (PICF).
- Participants must be able to undergo MRI, undertake neuropsychological and EEG assessments, and tolerate the PMBT therapy.
Minimum age
50 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Diagnosed dementia and mild cognitive impairment
- Significant psychiatric history including psychosis, bipolar disorder, major depressive disorder including suicidality.
- Any unstable medical (e.g., severe/uncontrolled hypertension) or neurological condition (e.g., Parkinson’s Disease)
- Severe cardiovascular disease, history of stroke, recent myocardial infarction
- Any contraindication to MRI or PBMT therapy
- Development of serious, adverse, or unexpected events/reactions during the trial
- Previous reaction to PBMT therapy

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
Feasibility/Acceptability pilot study, Desired sample size N=30.

Statistical analyses will be generalised linear models (GLMs), analysis of the relative change index, frequency statistics, and use appropriate descriptive statistics, t-tests, ANOVA/ANCOVA to evaluate pre-post changes from baseline to post intervention follow up looking for changes that may signal initial efficacy of intervention.

A significance level of p<.05 will be utilised where required. Data will be inspected for outliers and any spurious data will be corrected or removed prior to analysis. Brain imaging data will be analysed as per internationally accepted analyses routines (eg FSL and SPM).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/10/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
29/07/2024
Actual
Sample size
Target
30
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 314764 0
Commercial sector/Industry
Name [1] 314764 0
Brain Gear Inc
Country [1] 314764 0
Korea, Republic Of
Primary sponsor type
University
Name
The University of the Sunshine Coast
Address
Thompson Institute, The University of the Sunshine Coast, 12 Innovation Parkway, Birtinya QLD 4575, Sunshine Coast
Country
Australia
Secondary sponsor category [1] 316749 0
None
Name [1] 316749 0
Address [1] 316749 0
Country [1] 316749 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313772 0
The University of the Sunshine Coast Human Research Ethics Committee
Ethics committee address [1] 313772 0
Ethics committee country [1] 313772 0
Australia
Date submitted for ethics approval [1] 313772 0
04/09/2023
Approval date [1] 313772 0
15/09/2023
Ethics approval number [1] 313772 0

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

Contacts
Principal investigator
Name 129314 0
Dr Sophie Andrews
Address 129314 0
Thompson Institute, 12 Innovation Parkway, Birtinya 4575 QLD
Country 129314 0
Australia
Phone 129314 0
+61 754594476
Fax 129314 0
Email 129314 0
[email protected]
Contact person for public queries
Name 129315 0
Sophie Andrews
Address 129315 0
Thompson Institute, 12 Innovation Parkway, Birtinya 4575 QLD
Country 129315 0
Australia
Phone 129315 0
+61 754594476
Fax 129315 0
Email 129315 0
[email protected]
Contact person for scientific queries
Name 129316 0
Sophie Andrews
Address 129316 0
Thompson Institute, 12 Innovation Parkway, Birtinya 4575 QLD
Country 129316 0
Australia
Phone 129316 0
+61 754594476
Fax 129316 0
Email 129316 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
As this is a feasibility study, we do not plan to share the individual data, however, manuscripts containing overall average outcomes are planned.


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.