Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Effectiveness of Photobiomodulation With Exercise, to Enhance Motor, Cognition and the Quality of Life of Those With Parkinson's Disease

Trial ID: NCT06036433

Interventional - Phase Unknown - Unknown status

Parkinson's disease (PD) is a lifelong and progressive disease and is the second most common progressive neurodegenerative disease worldwide. This study will examine whether there are significant differences in motor (e.g., balance and gait) and non-motor (e.g., cognition, mood, smell \& sleep ) symptoms and quality of life between the Real (active) at-home photobiomodulation (light therapy) combined with exercise group and the Placebo (sham) at-home photobiomodulation (light therapy) combined with exercise group. Each group (Real \& Placebo) will include 30 participants; with moderate PD, ages 55-80. Three outcome measurement sessions will be conducted; at the study entry and the end of Weeks 1 \& 4 after the last light therapy treatment. Exercise must have been part of the participant's routine before entering the study and will continue during and after the light therapy treatments have been completed.

Conditions

• Parkinson's
• Disease

Interventions

• Infrared laser photobiomodulation device
• Infrared & Red LED photobiomodulation device

Eligibility

Inclusion criteria

• - Neurologist-diagnosed Hoehn and Yahr Stages 2-3 (moderate) idiopathic PD;
• With or without anti-Parkinson's Disease medications;
• Able to attend the PD Wellness & Innovation Centre in Hamilton, Ontario, Canada,
• Participating in exercise program prior to enrolment

Exclusion criteria

• - Previous PBM treatment
• MOCA score of ≤23/30
• Insufficient understanding of English to sign an informed consent, understand teaching and to perform at-home PBM treatment
• Physically unable to perform tasks required for outcome measurement testing
• History of significant unstable musculoskeletal or neurological disorders or unstable cardiac condition

Sponsor

Gaitway Neurophysio

Last updated: 2025-05-26 · Source: Clinicaltrials.gov

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