Clinical trial NCT06036433: Light Therapy Plus Exercise to Improve Motor, Non-Motor Symptoms and QoL in Parkinson's Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson's
Disease
Keywords: Photobiomodulation
Light
Laser
Therapy
Transcranial
Abdominal
Neurologic
Neurodegenerative
Lead sponsor: Gaitway Neurophysio
Sponsor class: OTHER
First posted: 2023-09-14
Enrollment: 60
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: There are two study arms; the first is a randomized, controlled, double-blind design with Real (Active) and Placebo groups. The study will evaluate the effect of light therapy (photobiomodulation - PBM) on treating the symptoms of moderate-stage PD. Regular exercise is a study prerequisite and must continue throughout the study. There are 30 per group, ages 55-80. Both groups will complete 30-minute, at-home PBM treatments, 3 days/week x 8 weeks (total of 24). Then devices are returned. Subjects have outcome measurement testing at Entry and the end of Weeks 1 \& 4 after the last PBM treatment.

The Crossover includes both the Active \& Placebo groups interested in participating in the same 8-week at-home Real PBM protocol outlined above. The same education and weekly support in the first arm is provided in the second arm of the study. Then the devices are returned. Outcome measurement testing will be conducted 1 and 4 weeks after the last PBM treatment.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Parkinson's disease (PD) is a lifelong and progressive disease; symptoms slowly worsen over time. PD worldwide is the second most common progressive neurodegenerative disease after Alzheimer's disease. To date there is no cure and few long term effective treatment options.

This research study will use two photobiomodulation (light therapy) devices for at-home treatment by the participant using near-infrared (NIR) and visible red photobiomodulation (PBM). Eligible individuals include those with moderate stage PD and between 55-80 years old. The Real (Active) Group (n=30) will be compared with the Placebo (Sham) group (n=30) to determine whether there are significant differences in motor, cognition and QoL. Exercise will have been part of the subject's routine before entering the study and will continue after the PBM treatments have been completed.

PBM treatments include abdominal and transcranial applications. We believe this is the first combined PBM treatment protocol being used in Canada. Placebo and Real PBM devices look and function the same. The treatment protocol used in this trial is similar to recent Australian PD research using a combination of laser and light-emitting diode (LED) treatments. For almost 20 years, similar transcranial LED parameters have been used safely and effectively to treat traumatic brain injury (TBI), aphasia post stroke and Alzheimer's disease and other dementias.

Eligibility criteria: 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

Primary outcomes:
measure: Timed up-and-go (TUG) to measure change from baseline compared to Endpoints at Weeks 1 and 4 Post Treatment. (TUG) test
timeFrame: Administered in Arm 1 & 2 at baseline and 1 and 4 weeks after treatment has been completed. Each arm is 12 weeks.
Secondary outcomes:
measure: Parts I-VI of the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS UPDRS) - to measure change from baseline compared to Endpoints at 1 and 4 weeks Post Treatment
timeFrame: Administered in Arms 1 & 2 at baseline and at Weeks 1 & 4 post treatment. Each arm is 12 weeks.
measure: 10-meter walk Test (10MWT) speed and stride to measure change from baseline compared to Endpoints at weeks 1 and 4 Post Treatment
timeFrame: Administered in Arms 1 & 2 at baseline and Weeks 1 & 4 post treatment. Each arm is 12 weeks.
measure: Montreal Cognitive Assessment (MoCA) to measure change from baseline compared to Endpoints at Weeks 1 and 4 Post Treatment
timeFrame: Administered in Arms 1 & 2 at baseline and Weeks 1 & 4 post treatment. Each arm is 12 weeks.
measure: Nine-hole peg test (NHPT) to measure change from baseline compared to Endpoints at Weeks 1 and 4 Post Treatment
timeFrame: Administered in Arms 1 & 2 at baseline and Weeks 1 & 4 post treatment. Each arm is 12 weeks.
measure: Spiral Test to measure fine motor change from baseline compared with Weeks 1 & 4 post treatment.
timeFrame: Administered in Arms 1 & 2 at baseline and Weeks 1 & 4 post treatment. Each arm is 12 weeks.
measure: Writing Test to measure fine motor changes from baseline compared to Weeks 1 & 4 post treatment.
timeFrame: Administered in Arms 1 & 2 at baseline and Weeks 1 & 4 post treatment. Each arm is 12 weeks in duration.
measure: Parkinson's Disease Quality of Life 39 (PDQ39) to measure change from baseline compared to Endpoints at Weeks 1 and 4 Post Treatment
timeFrame: Administered in Arms 1 & 2 at baseline and Weeks 1 & 4 post treatment. Each arm is 12 week. .
measure: Parkinson's Disease Sleep Scale ( PDSS) to measure change from baseline compared to Endpoints at Weeks 1 and 4 Post Treatment
timeFrame: Administered in Arms 1 & 2 at baseline and Weeks 1 & 2 post treatment. Each arm is 12 weeks.
measure: Smell test to measure change from baseline compared to Endpoints at Weeks 1 and 4 Post Treatment
timeFrame: Administered in Arms 1 & 2 at baseline and Weeks 1 & 2 post treatment. Each arm is 12 weeks.
measure: Beck Depression Inventory (BDI) to measure change form baseline compared to Endpoints at Weeks 1 and 4 post treatment
timeFrame: Administered in Arms 1 & 2 at baseline and Weeks 1 & 2 post treatment. Each arm is a total of 12 weeks in total.
measure: Beck Anxiety Inventory (BAI) to measure change from baseline compared to Endpoints at Weeks 1 and 4 Post Treatment
timeFrame: Administered in Arms 1 & 2 at baseline and Weeks 1 & 2 post treatment. Each arm is a total of 12 weeks.
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Gaitway Neurophysio and Parkinson's Wellness Innovation Centre
state: Ontario
Study officials:
affiliation: Saltmarche Health & Associates
name: Anita Saltmarche, MHSc
role: STUDY_CHAIR
affiliation: Neuro Physio at Gaitway Neurophysio and Parkinson's Wellness Innovation Centre
name: Orla Hares, PT
role: PRINCIPAL_INVESTIGATOR
References: