Menu
Recruiting NCT07271927

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

No phase Interventional PARKINSON DISEASE (Disorder)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Photobiomodulation.
Who it may be relevant to
Registry conditions: PARKINSON DISEASE (Disorder). Basic parameters: from 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Device Photobiomodulation
    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 outcome measures

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

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • Pusan National University Yangsan Hospital — Yangsan

Identifiers

NCT: NCT07271927 · 23-2024-005

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗