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

NCT06036433 | Unknown

• 1 other identifier: PBM&exerciseforPDCanada
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's; Disease

Keywords

Photobiomodulation; Light; Laser; Therapy; Transcranial; Abdominal; Neurologic; Neurodegenerative

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• 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.

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

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

ACTIVE COMPARATOR

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.

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

Active and Placebo Cross Over

OTHER

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.

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

Interventions

Infrared laser photobiomodulation device 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.

Also known as: PDCare Laser by Symbyx Biome Therapies

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

Infrared & Red LED photobiomodulation device 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.

Also known as: PDNeuro v2.0 by Symbyx

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

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gaitway Neurophysio: lead

Study Sites (1)

Gaitway Neurophysio and Parkinson's Wellness Innovation Centre

Hamilton, Ontario, L8P 2B6, Canada

RECRUITING

Related Links

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

MeSH Terms

Conditions

Parkinson Disease; Disease; Neurologic Manifestations

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Anita Saltmarche, MHSc

  Saltmarche Health & Associates

  STUDY CHAIR

• Orla Hares, PT

  Neuro Physio at Gaitway Neurophysio and Parkinson's Wellness Innovation Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Orla Hares, PT

CONTACT

1-906-974-9892; research@gaitwayneurophysio.com

Orla Hares, PT

CONTACT

orla@gaitwayneurophysio.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: September 14, 2023
• Study Start: January 2, 2023
• Primary Completion: January 1, 2024
• Study Completion: May 1, 2024
• Last Updated: September 15, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)