PARKINSON DISEASE (Disorder)
Conditions
Keywords
Photobiomodulation, Parkinson disease, cognition, motor function, light theraphy
Brief 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.
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%).
Sponsors
Pusan National University Yangsan Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| UPDRS | 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
| Measure | Time frame | Description |
|---|---|---|
| SVLT | 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 |
| RCFT | 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 |
| DST | Change in DST scores from baseline to post 30 sessions (up to approximately 10 weeks). Higher scores indicate better performance. | Digit span test |
| TMT | 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 |
| CTRS | 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 |
| Grip strength and pinch strength test | 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 |
| FRT | 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 |
| TUG | 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 |
| K-CWST | 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 |
| BBS | 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 |
Countries
South Korea
Contacts
Primary ContactJisoo Baik
Outcome results
None listed