Improve motor and cognitive function

Trial ID
NCT07271927
Official Title
Evaluation Study of the Effects and Safety of Whole-Body Photobiomodulation Therapy on Motor and Cognitive Changes in Patients With Parkinson's Disease
Goal
Improve motor and cognitive function
Phase
NA
Status
RECRUITING
Sponsor
Pusan National University Yangsan Hospital
Study Type
INTERVENTIONAL
Enrollment
15 participants
Conditions
PARKINSON DISEASE (Disorder)
Interventions
Photobiomodulation

Summary For Families

The trial wants to find out whether whole-body photobiomodulation can improve movement and thinking problems in people with Parkinson's, while checking that the treatment is safe. Photobiomodulation uses low-level red and near-infrared light applied to the body to stimulate mitochondria, boost cellular energy (ATP), and reduce inflammation and oxidative stress, which may protect neurons and help motor and cognitive function; it is a non-drug therapy meant to be used alongside standard medications like levodopa, not to replace them. Adults aged 40 and up with Parkinson's at Hoehn and Yahr stages 1 to 3 who can walk independently are eligible, while people with very severe cognitive impairment (K-MMSE ≤ 9), implanted electronic devices, a history of seizures or serious psychiatric or medical issues, pregnancy, or recent participation in multiple trials are excluded.

Locations

  • Pusan National University Yangsan Hospital, Yangsan, Gyeongsangnam-do, South Korea

Frequently Asked Questions

What is this trial testing?
This trial is studying Photobiomodulation. The trial wants to find out whether whole-body photobiomodulation can improve movement and thinking problems in people with Parkinson's, while checking that the treatment is safe. Photobiomodulation uses low-level red and near-infrared light applied to the body to stimulate mitochondria, boost cellular energy (ATP), and reduce inflammation and oxidative stress, which may protect neurons and help motor and cognitive function; it is a non-drug therapy meant to be used alongside standard medications like levodopa, not to replace them. Adults aged 40 and up with Parkinson's at Hoehn and Yahr stages 1 to 3 who can walk independently are eligible, while people with very severe cognitive impairment (K-MMSE ≤ 9), implanted electronic devices, a history of seizures or serious psychiatric or medical issues, pregnancy, or recent participation in multiple trials are excluded.
Who can participate?
Participants must be at least 40 Years.
Where is this trial located?
This trial is recruiting at 1 location.
Does it cost anything to join?
No. There is no cost to participate. Study-related care and treatment are provided at no charge.
How long does the trial last?
This trial is estimated to last approximately 10 months.
Will I get the real drug or a placebo?
It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
How often will I need to visit the study site?
Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
Can I leave the trial if I change my mind?
Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
Will travel or parking be reimbursed?
Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
Can my spouse or care partner come with me to visits?
In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.

Related Reading

View on ClinicalTrials.gov