RecruitingNot ApplicableNCT07271927

Whole-Body Photobiomodulation for Motor and Cognitive Changes in Parkinson's Disease

Evaluation Study of the Effects and Safety of Whole-Body Photobiomodulation Therapy on Motor and Cognitive Changes in Patients With Parkinson's Disease


Sponsor

Pusan National University Yangsan Hospital

Enrollment

15 participants

Start Date

Feb 12, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study aims to exploratorily evaluate the extent of motor and cognitive changes, as well as the safety, resulting from approximately 10 weeks of whole-body photobiomodulation (PBM) therapy (about three sessions per week, once daily, 20 minutes per session) in patients with Parkinson's disease.


Eligibility

Min Age: 40 Years

Inclusion Criteria3

  • Individuals diagnosed with Parkinson's disease at Hoehn and Yahr stages 1-3 based on medical history and examination
  • Adults aged 40 years or older
  • Individuals able to walk independently

Exclusion Criteria14

  • Individuals with severe cognitive impairment (Korean Mini-Mental State Examination \[K-MMSE\] score ≤ 9) making it difficult to understand and perform tasks
  • Patients with dementia other than Parkinson's disease dementia
  • Individuals with implanted medical or other electronic devices
  • Individuals with severe neuropsychiatric disorders
  • Individuals treated for alcohol dependence within 6 months prior to screening
  • Individuals with a history of suicide attempts
  • Individuals with a history of seizures
  • Individuals experiencing dyspnea while sitting at rest
  • Individuals with visual impairment preventing them from reading ordinary text even with corrective lenses
  • Individuals with hearing impairment preventing them from understanding conversation even with a hearing aid
  • Individuals who have participated in two or more clinical trials in the same year or in another clinical trial within the past 6 months
  • Women and men of childbearing potential who are planning pregnancy during the trial or who do not agree to use appropriate contraceptive methods
  • Pregnant or breastfeeding women
  • Individuals deemed medically inappropriate for participation by the principal investigator or study staff based on clinically significant findings not otherwise specified above

Interventions

DEVICEPhotobiomodulation

Participants received whole-body PBM therapy over approximately 10 weeks (three sessions per week, once daily, 20 minutes per session), with each session using a randomly selected wavelength of either 660 nm, 850 nm, or 940 nm (±20%).


Locations(1)

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, South Korea

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NCT07271927


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