Light Therapy Plus Exercise to Improve Motor, Non-Motor Symptoms and QoL in Parkinson's Disease

Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06036433
• Other study ID #: PBM&exerciseforPDCanada
• Status: Recruiting
• Phase: N/A
• Start date: January 2, 2023
• Est. completion date: May 2024

Study information

• Verified date: September 2023
• Source: Gaitway Neurophysio
• Contact: Orla Hares, PT
• Phone: 1-906-974-9892
• Email: research[@]gaitwayneurophysio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 80 Years

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

Related Conditions & MeSH terms

• Disease
• Parkinson Disease
• Parkinson's

Intervention

Device:
• Infrared laser photobiomodulation device
904 super pulsed Infrared laser PBM therapy for the treatment of the signs and symptoms associated with Parkinson's, such as improved motor, non-motor and Quality of Life.
• Infrared & Red LED photobiomodulation device
Infrared & red LED therapy for the treatment of the signs and symptoms associated with Parkinson's, such as motor, non-motor and Quality of Life.

Locations

Country	Name	City	State
Canada	Gaitway Neurophysio and Parkinson's Wellness Innovation Centre	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Gaitway Neurophysio

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Timed up-and-go (TUG) to measure change from baseline compared to Endpoints at Weeks 1 and 4 Post Treatment. (TUG) test	Time taken to stand from a chair, walk 3m, turn around at a marker, return and sit down. Lower time is a better outcome.	Administered in Arm 1 & 2 at baseline and 1 and 4 weeks after treatment has been completed. Each arm is 12 weeks.
Secondary	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	Part I) Mentation, Behavior, and Mood, scored in time, range 0-16, lower score is a better outcome; II) ADL score is 0-52, lower score is better outcome: III) Motor portion, score 0-108, lower score is better outcome; IV) Complications of Therapy (in the past week), scores from 0-23, lower is better outcome; V) Modified Hoehn and Yahr Scale, score from 1-5, lower score is better outcome and VI) Schwab and England ADL scale is scored as a percentage, a lower percentage is a better outcome.	Administered in Arms 1 & 2 at baseline and at Weeks 1 & 4 post treatment. Each arm is 12 weeks.
Secondary	10-meter walk Test (10MWT) speed and stride to measure change from baseline compared to Endpoints at weeks 1 and 4 Post Treatment	assessment of gait, scored by timing completion and counting steps, lower scores are a better outcome.	Administered in Arms 1 & 2 at baseline and Weeks 1 & 4 post treatment. Each arm is 12 weeks.
Secondary	Montreal Cognitive Assessment (MoCA) to measure change from baseline compared to Endpoints at Weeks 1 and 4 Post Treatment	assessment of cognitive abilities, scored 0-30 (higher scores are better.)	Administered in Arms 1 & 2 at baseline and Weeks 1 & 4 post treatment. Each arm is 12 weeks.
Secondary	Nine-hole peg test (NHPT) to measure change from baseline compared to Endpoints at Weeks 1 and 4 Post Treatment	test for fine motor skills, timing both the dominant and non-dominant hands. Faster times are a better outcome.	Administered in Arms 1 & 2 at baseline and Weeks 1 & 4 post treatment. Each arm is 12 weeks.
Secondary	Spiral Test to measure fine motor change from baseline compared with Weeks 1 & 4 post treatment.	Spiral drawing is a skilled and complex coordinated motor activity. Scores are based on time and accuracy, a lower scores is a better outcome.	Administered in Arms 1 & 2 at baseline and Weeks 1 & 4 post treatment. Each arm is 12 weeks.
Secondary	Writing Test to measure fine motor changes from baseline compared to Weeks 1 & 4 post treatment.	Writing test is administered to assess for bradykinesia, micrographia and tremor in Parkinson's disease. Size and quality of writing determine outcome or change.	Administered in Arms 1 & 2 at baseline and Weeks 1 & 4 post treatment. Each arm is 12 weeks in duration.
Secondary	Parkinson's Disease Quality of Life 39 (PDQ39) to measure change from baseline compared to Endpoints at Weeks 1 and 4 Post Treatment	Quality of Life, scored in percentage (0-100%), lower score is a better outcome.	Administered in Arms 1 & 2 at baseline and Weeks 1 & 4 post treatment. Each arm is 12 week. .
Secondary	Parkinson's Disease Sleep Scale ( PDSS) to measure change from baseline compared to Endpoints at Weeks 1 and 4 Post Treatment	self-rate and quantify the level of sleep disruption, 0-60, lower score is a better outcome.	Administered in Arms 1 & 2 at baseline and Weeks 1 & 2 post treatment. Each arm is 12 weeks.
Secondary	Smell test to measure change from baseline compared to Endpoints at Weeks 1 and 4 Post Treatment	Investigator administers 4 scents to evaluate the sense of smell, scored between 0-12; higher score is a better outcome.	Administered in Arms 1 & 2 at baseline and Weeks 1 & 2 post treatment. Each arm is 12 weeks.
Secondary	Beck Depression Inventory (BDI) to measure change form baseline compared to Endpoints at Weeks 1 and 4 post treatment	is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression; lower score is a better outcome.	Administered in Arms 1 & 2 at baseline and Weeks 1 & 2 post treatment. Each arm is a total of 12 weeks in total.
Secondary	Beck Anxiety Inventory (BAI) to measure change from baseline compared to Endpoints at Weeks 1 and 4 Post Treatment	is a 21-question multiple-choice self-report inventory used to measure how the subject has been feeling in the last week, focusing primarily on somatic symptoms; lower score is a better outcome.	Administered in Arms 1 & 2 at baseline and Weeks 1 & 2 post treatment. Each arm is a total of 12 weeks.

External Links

•   Study is being conducted at Parkinson's Wellness & Innovation Centre