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

Gaitway Neurophysio

Status: Enrolling

Conditions: Disease; Parkinson's

Treatments: Device: Infrared & Red LED photobiomodulation device; Device: Infrared laser photobiomodulation device

Study type: Interventional

Funder types: Other

Identifiers

NCT06036433

PBM&exerciseforPDCanada

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 55 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

60 participants in 2 patient groups

Randomized, Placebo Controlled, Double-Blind Clinical Trial Real ( Active) vs. Placebo (Sham)

Active Comparator group

Description:

The first arm includes the real (active) group (n=30) and the placebo (sham) group (n=30). Both groups will self-administer their at-home photobiomodulation (PBM) therapy with devices that either emit active light energy or emit no light energy, respectively. The 30 minute treatment is completed 3 x per week. The protocol includes abdominal PBM treatment with a hand held infrared device and transcranial PBM treatment with an infrared \& red LED helmet. Participants are taught how to administer their own treatment and are provided with weekly follow-up. At the completion of the 24 treatments the devices are returned. Post outcome measurement testing is conducted at baseline and 1 and 4 weeks after the last PBM treatment. An inclusion criteria requires that subjects have been exercising 3 x per week before entering the study and continue the minimum level of exercise throughout the study. Data from the Real group will be compared with the results from in the Placebo group.

Treatment:

Device: Infrared laser photobiomodulation device

Device: Infrared & Red LED photobiomodulation device

Active and Placebo Cross Over

Other group

Description:

After the first arm of the study is completed and the post treatment assessments administered, participants in the Active and Placebo groups will be offered the option to complete 8 weeks of real (active) at-home PBM treatment of the abdomen and head (transcranial), 3 x per week for a total of 24 treatments. Each treatment takes approximately 30 minutes to complete. The devices are then returned. Outcome measurement testing will be conducted at Weeks 1 and 4 weeks after the last treatment.

Treatment:

Device: Infrared laser photobiomodulation device

Device: Infrared & Red LED photobiomodulation device