Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000845639
Ethics application status
Approved
Date submitted
20/07/2023
Date registered
7/08/2023
Date last updated
16/11/2023
Date data sharing statement initially provided
7/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Can a Red Light Helmet with or without Hyperbaric Oxygen Therapy improve cognition in adults with mild and moderate cognitive impairment?
Scientific title
The Effect of Photobiomodulation with or without Hyperbaric Oxygen Therapy on Cognition in Adults with Mild and Moderate Cognitive Impairment
Secondary ID [1] 309672 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild Cognitive Impairment 330025 0
Condition category
Condition code
Neurological 326932 326932 0 0
Dementias
Neurological 326933 326933 0 0
Parkinson's disease
Neurological 326934 326934 0 0
Neurodegenerative diseases
Neurological 326947 326947 0 0
Alzheimer's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There will be 3 treatment arms.
All participants will receive:
Photobiomodulation (PBM) will be applied using the WellRed Duo Coronet. This helmet-like device is made of aluminium and has light emitting diodes (LEDs) positioned at regular intervals to cover the entire head. It contains LEDs in two wavelengths of red and near infrared light – 670nm and 810nm. Both wavelengths are pulsed at 40Hz at a voltage of 12V DC, with the 2 wavelengths being automatically switched. Each participant will receive their own Duo Coronet to self-administer at home twice daily for either 8 weeks (groups 1 & 2) or 16 weeks (group 3). Each session lasts 24 minutes (2x12 minutes consecutively at each wavelength). One treatment arm (group 2) will also receive Hyperbaric Oxygen Therapy (HBOT) at the National Institute of Integrative Medicine (NIIM) clinic twice weekly for 8 weeks in addition to twice daily PBM treatment. Each HBOT session will involve breathing 100% oxygen at atmopheric pressure of 2 Atmospheric Absolute Pressure (ATA) for 60 minutes in NIIM’s Perry Baromedical monoplace HBOT chamber. HBOT sessions will be conducted by a certified nurse and operator.
Adherence to daily sessions will be monitored by participant diaries.
Intervention code [1] 326110 0
Treatment: Devices
Comparator / control treatment
Control run-in period of 2 weeks will be conducted before baseline measurements where participants will wear the device twice daily for 24 minutes without turning it on. Pre-post treatment assessment will allow participants to act as their own control. HBOT treatment for group 2 won't be applied in the run-in period.
Control group
Active

Outcomes
Primary outcome [1] 334766 0
Structural MRI assessing composite of change in hippocampal volume, grey cortical matter volume, and cortical thickness.
Timepoint [1] 334766 0
Baseline (pre-treatment) compared to 4 months (primary timepoint), and 6 months (follow-up) post-treatment commencement
Primary outcome [2] 334871 0
Functional connectivity assessed by resting state functional MRI.
Timepoint [2] 334871 0
Baseline (pre-treatment) compared to 4 months (primary timepoint), and 6 months (follow-up) post-treatment commencement
Primary outcome [3] 334872 0
Composite cognitive executive functioning assessed by four validated cognitive exams:
Mini Mental State Examination (MMSE) Score
Symbol Digits Modalities Test (SDMT) Score
Hopkins Verbal Learning Test-Revised (HVLT-r) Score
Montreal Cognitive Assessment (MoCA) Score
Timepoint [3] 334872 0
Baseline (pre-treatment) compared to 2 months & 4 months (primary timepoints), and 6 months (follow-up) post-treatment commencement
Secondary outcome [1] 422000 0
Cognitive performance composite score assessed by Swinburne University Computerized Cognitive Assessment Battery (SUCCAB), consisting of the following 8 tasks measuring reaction time and accuracy: Simple reaction time, Choice reaction time, Immediate recognition, Congruent stroop colour word, Incongruent stroop colour word, Spatial working memory, Contextual memory, Delayed recognition
Timepoint [1] 422000 0
Baseline (pre-treatment) compared to 2 months & 4 months, and 6 months post-treatment commencement
Secondary outcome [2] 422297 0
Mood assessed by Bond-Lader Likert scale.
Timepoint [2] 422297 0
Baseline (pre-treatment) compared to 2 months & 4 months, and 6 months post-treatment commencement

Eligibility
Key inclusion criteria
Adults with mild to moderate cognitive impairment according to screening test (Telephone Interview for Cognitive Status score <24)
Confident/comfortable talking on the phone to conduct screening and schedule appointments.
Normal blood test results - Specifically Vit B12
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not able to provide consent
Pacemaker
Metal/electronic implants or other condition/s making them ineligible for MRI scans
Taking potentially photosensitising medication (some types of antidepressants, antibiotics etc.)
Poor comprehension of written or spoken English
Unable to perform pen and paper or computerized cognitive tests
Colour blind

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)
After receiving expression of interest, potential participants will be contacted via phone to conduct initial screening using the Telephone Interview for Cognitive Status (TICS-M Australian version). If eligible (score <24), the participant will be invited to NIIM to gain informed consent, conduct initial blood tests, and discuss HBOT eligibility. If blood test results are normal, the participant will be randomly allocated to treatment group and will receive their WellRed DUO Coronet with instructions for use.

The researcher responsible for enrolling a participant will not be aware of group allocation at the time of enrolment. Additional eligibility will be conducted for HBOT before participants are randomly allocated to treatment group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
After accounting for HBOT eligibility, participants will be allocated to treatment group by computer-generated permuted block randomisation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
3 different treatment arms.
Group 1: PBM 8 weeks daily
Group 2: PBM 8 weeks daily + HBOT twice weekly for 8 weeks
Group 3: PBM 16 weeks daily
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size: Pilot study of 30 participants (n=10 per treatment group) to advise future studies.

Data analysis will be performed using SPSS. Statistical significance will be set at p<0.05. Difference within-groups and between-groups at baseline, 2 months, 4 months, and 6 months will be assessed by chi-squared test for binomial variables, Kruskal-Wallis test for ordinal variables, and by one-way ANCOVA with Bonferroni adjustment and post-hoc Dunnett's test for continuous variables. Analysis of structural and functional MRIs will be conducted by collaborating investigator Prof Linda Chao (University of California, San Francisco, USA) using Freesurfer.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/08/2023
Actual
4/09/2023
Date of last participant enrolment
Anticipated
30/11/2023
Actual
Date of last data collection
Anticipated
31/05/2024
Actual
Sample size
Target
30
Accrual to date
12
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 40384 0
3122 - Hawthorn
Recruitment postcode(s) [2] 40840 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 313864 0
Charities/Societies/Foundations
Name [1] 313864 0
National Institute of Integrative Medicine
Country [1] 313864 0
Australia
Primary sponsor type
Individual
Name
Dr Karin Ried
Address
National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn VIC 3122
Country
Australia
Secondary sponsor category [1] 315713 0
None
Name [1] 315713 0
Address [1] 315713 0
Country [1] 315713 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313013 0
National Institute of Integrative Medicine Human Research Ethics Committee (NIIM HREC)
Ethics committee address [1] 313013 0
Ethics committee country [1] 313013 0
Australia
Date submitted for ethics approval [1] 313013 0
05/05/2023
Approval date [1] 313013 0
18/07/2023
Ethics approval number [1] 313013 0
0124N_2023

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

Contacts
Principal investigator
Name 126678 0
A/Prof Karin Ried
Address 126678 0
National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn VIC 3122
Country 126678 0
Australia
Phone 126678 0
+61 3 9912 9545
Fax 126678 0
Email 126678 0
[email protected]
Contact person for public queries
Name 126679 0
Karin Ried
Address 126679 0
National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn VIC 3122
Country 126679 0
Australia
Phone 126679 0
+61 3 9912 9545
Fax 126679 0
Email 126679 0
[email protected]
Contact person for scientific queries
Name 126680 0
Karin Ried
Address 126680 0
National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn VIC 3122
Country 126680 0
Australia
Phone 126680 0
+61 3 9912 9545
Fax 126680 0
Email 126680 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19753Ethical approval    385905-(Uploaded-20-07-2023-06-34-08)-Study-related document.pdf



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.