Disease, Parkinson's
Conditions
Keywords
Photobiomodulation, Light, Laser, Therapy, Transcranial, Abdominal, Neurologic, Neurodegenerative
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.
Interventions
DEVICEInfrared 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.
DEVICEInfrared & 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.
Sponsors
Gaitway Neurophysio
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants are unaware of which device they are receiving. The outcomes assessor is unaware of subject randomization and is not involved with any teaching or follow-up of the participants.
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.
Eligibility
Sex/Gender
ALL
Age
55 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Timed up-and-go (TUG) to measure change from baseline compared to Endpoints at Weeks 1 and 4 Post Treatment. (TUG) test | Administered in Arm 1 & 2 at baseline and 1 and 4 weeks after treatment has been completed. Each arm is 12 weeks. | Time taken to stand from a chair, walk 3m, turn around at a marker, return and sit down. Lower time is a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 10-meter walk Test (10MWT) speed and stride to measure change from baseline compared to Endpoints at weeks 1 and 4 Post Treatment | Administered in Arms 1 & 2 at baseline and Weeks 1 & 4 post treatment. Each arm is 12 weeks. | assessment of gait, scored by timing completion and counting steps, lower scores are a better outcome. |
| Montreal Cognitive Assessment (MoCA) to measure change from baseline compared to Endpoints at Weeks 1 and 4 Post Treatment | Administered in Arms 1 & 2 at baseline and Weeks 1 & 4 post treatment. Each arm is 12 weeks. | assessment of cognitive abilities, scored 0-30 (higher scores are better.) |
| Nine-hole peg test (NHPT) to measure change from baseline compared to Endpoints at Weeks 1 and 4 Post Treatment | Administered in Arms 1 & 2 at baseline and Weeks 1 & 4 post treatment. Each arm is 12 weeks. | test for fine motor skills, timing both the dominant and non-dominant hands. Faster times are a better outcome. |
| Spiral Test to measure fine motor change from baseline compared with Weeks 1 & 4 post treatment. | Administered in Arms 1 & 2 at baseline and Weeks 1 & 4 post treatment. Each arm is 12 weeks. | Spiral drawing is a skilled and complex coordinated motor activity. Scores are based on time and accuracy, a lower scores is a better outcome. |
| Writing Test to measure fine motor changes from baseline compared to Weeks 1 & 4 post treatment. | Administered in Arms 1 & 2 at baseline and Weeks 1 & 4 post treatment. Each arm is 12 weeks in duration. | Writing test is administered to assess for bradykinesia, micrographia and tremor in Parkinson's disease. Size and quality of writing determine outcome or change. |
| 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 | Administered in Arms 1 & 2 at baseline and at Weeks 1 & 4 post treatment. Each arm is 12 weeks. | 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. |
| Parkinson's Disease Sleep Scale ( PDSS) to measure change from baseline compared to Endpoints at Weeks 1 and 4 Post Treatment | Administered in Arms 1 & 2 at baseline and Weeks 1 & 2 post treatment. Each arm is 12 weeks. | self-rate and quantify the level of sleep disruption, 0-60, lower score is a better outcome. |
| Smell test to measure change from baseline compared to Endpoints at Weeks 1 and 4 Post Treatment | Administered in Arms 1 & 2 at baseline and Weeks 1 & 2 post treatment. Each arm is 12 weeks. | Investigator administers 4 scents to evaluate the sense of smell, scored between 0-12; higher score is a better outcome. |
| Beck Depression Inventory (BDI) to measure change form baseline compared to Endpoints at Weeks 1 and 4 post treatment | Administered in Arms 1 & 2 at baseline and Weeks 1 & 2 post treatment. Each arm is a total of 12 weeks in total. | is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression; lower score is a better outcome. |
| Beck Anxiety Inventory (BAI) to measure change from baseline compared to Endpoints at Weeks 1 and 4 Post Treatment | Administered in Arms 1 & 2 at baseline and Weeks 1 & 2 post treatment. Each arm is a total of 12 weeks. | 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. |
| Parkinson's Disease Quality of Life 39 (PDQ39) to measure change from baseline compared to Endpoints at Weeks 1 and 4 Post Treatment | Administered in Arms 1 & 2 at baseline and Weeks 1 & 4 post treatment. Each arm is 12 week. . | Quality of Life, scored in percentage (0-100%), lower score is a better outcome. |
Countries
Canada
Contacts
Primary ContactOrla Hares, PT
Backup ContactOrla Hares, PT
Outcome results
None listed