Recruiting

Photobiomodulation

Sponsor:

Gaitway Neurophysio

Code:

NCT06036433

Conditions

Parkinson's

Disease

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

Interventions

Infrared laser photobiomodulation device

Infrared & Red LED photobiomodulation device

Study Details

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

Study ID

NCT06036433

Start date

Jan 2, 2023

Status verified date

Sep, 2023

Completion date

May, 2024

Anticipated

Primary completion date

Jan, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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.

other: Active and Placebo Cross Over

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.

Interventions

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.

Primary outcome measure

  • Timed up-and-go (TUG) to measure change from baseline compared to Endpoints at Weeks 1 and 4 Post Treatment. (TUG) test [ Time Frame: Administered in Arm 1 & 2 at baseline and 1 and 4 weeks after treatment has been completed. Each arm is 12 weeks. ]

Central Contacts and Locations

Central contacts

Orla Hares, PT

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

Orla Hares, PT

orla@gaitwayneurophysio.com

Locations

Gaitway Neurophysio and Parkinson's Wellness Innovation Centre

Recruiting

Hamilton, Ontario, Canada, L8P 2B6

Contacts

Orla Co-Principal Investigator, Reg. PT

1-905-974-9892orla@gailwayneurophysio.com

Orla Hare, PT

1-905-974-9892research@gaitwayneurophysio.com

Principal Investigator:

Anita Saltmarche, MHSc

More Information

Sponsor

Gaitway Neurophysio

Last update posted

Sep 15, 2023

Last verified

Sep, 2023

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Gaitway Neurophysio on 2023-09-15.