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NCT Number: NCT07271927

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

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.

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Key information

Conditions

PARKINSON DISEASE (Disorder) Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, 50612, South Korea

Location status: Recruiting

Location contact

Youjin Jeong

CONTACT

[email protected]

+82-55-360-4720

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Photobiomodulation

Device

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%).

Primary outcomes

  1. UPDRS

    Time frame: Change in UPDRS from baseline to post 30 sessions (up to approximately 10 weeks). The UPDRS ranges from 0 to 199, with higher scores indicating greater symptom severity.

    Unified Parkinson's Disease Rating Scale

Secondary outcomes

  1. BBS

    Time frame: Change in Berg Balance Scale scores from baseline to post 30 sessions (up to approximately 10 weeks). The BBS ranges from 0 to 56, with higher scores indicating better balance performance.

    Berg Balance Scale

  2. Grip strength and pinch strength test

    Time frame: Change in Grip strength and pinch strength from baseline to post 30 sessions (up to approximately 10 weeks). Higher scores indicate better hand function.

    Grasp, tip pinch & three jaw chuck

  3. FRT

    Time frame: Change in Functional Reach Test scores from baseline to post 30 sessions (up to approximately 10 weeks). Higher scores indicate better hand function.

    Functional Reach Test

  4. TUG

    Time frame: Change in Timed Up and Go test scores from baseline to post 30 sessions (up to approximately 10 weeks). Lower scores indicate better functional mobility.

    Timed Up and Go

  5. CTRS

    Time frame: Change in CRTS scores from baseline to post 30 sessions (up to approximately 10 weeks). The score ranges from 0 to 160, with higher scores indicating more severe tremor symptoms.

    Clinical Rating Scale for Tremor

  6. SVLT

    Time frame: Change in SVLT scores from baseline to post 30 sessions (up to approximately 10 weeks). The scores ranging from 0 to 36, where higher scores reflect better memory performance.

    Seoul verbal learning test

  7. RCFT

    Time frame: Change in RCFT scores from baseline to post 30 sessions (up to approximately 10 weeks). Higher scores indicate better visuospatial and memory performance.

    Rey complex figure test

  8. DST

    Time frame: Change in DST scores from baseline to post 30 sessions (up to approximately 10 weeks). Higher scores indicate better performance.

    Digit span test

  9. TMT

    Time frame: Change in TMT scores from baseline to post 30 sessions (up to approximately 10 weeks). Faster completion times (i.e., lower scores) indicate better cognitive function.

    Trail making test

  10. K-CWST

    Time frame: Change in K-CWST scores from baseline to post 30 sessions (up to approximately 10 weeks). Faster completion times (i.e., lower scores) indicate better cognitive function.

    Korean-Color word stroop test

Study contacts

Contact information is provided by the study sponsor or research team.

Jisoo Baik

CONTACT

[email protected]

082+055-360-4159

Sponsors and collaborators

Lead sponsor

Pusan National University Yangsan Hospital

Other

Registry information

Official study title

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

Acronym: PBM

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 9, 2025
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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