Can a Red Light Helmet with or without Hyperbaric Oxygen Therapy improve cognition in adults with mild and moderate cognitive impairment?

Not Applicable

Recruiting

• Conditions: Mild Cognitive Impairment; Neurological - Dementias; Neurological - Parkinson's disease; Neurological - Neurodegenerative diseases; Neurological - Alzheimer's disease

• Registration Number: ACTRN12623000845639
• Lead Sponsor: Dr Karin Ried

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-08-07
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

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

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Structural MRI assessing composite of change in hippocampal volume, grey cortical matter volume, and cortical thickness.[ Baseline (pre-treatment) compared to 4 months (primary timepoint), and 6 months (follow-up) post-treatment commencement];Functional connectivity assessed by resting state functional MRI.[ Baseline (pre-treatment) compared to 4 months (primary timepoint), and 6 months (follow-up) post-treatment commencement];Composite cognitive executive functioning assessed by four validated cognitive exams:<br>Mini Mental State Examination (MMSE) Score<br>Symbol Digits Modalities Test (SDMT) Score<br>Hopkins Verbal Learning Test-Revised (HVLT-r) Score<br>Montreal Cognitive Assessment (MoCA) Score[ Baseline (pre-treatment) compared to 2 months & 4 months (primary timepoints), and 6 months (follow-up) post-treatment commencement]

Secondary Outcome Measures

Name	Time	Method
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[ Baseline (pre-treatment) compared to 2 months & 4 months, and 6 months post-treatment commencement];Mood assessed by Bond-Lader Likert scale.[ Baseline (pre-treatment) compared to 2 months & 4 months, and 6 months post-treatment commencement]