NCT07271927招募中不适用
Evaluation Study of the Effects and Safety of Whole-Body Photobiomodulation Therapy on Motor and Cognitive Changes in Patients With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- UPDRS
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
UPDRS
时间窗: 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
次要结局
- 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.)
- 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.)
- FRT(Change in Functional Reach Test scores from baseline to post 30 sessions (up to approximately 10 weeks). Higher scores indicate better hand function.)
- 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.)
- 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.)
- 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.)
- RCFT(Change in RCFT scores from baseline to post 30 sessions (up to approximately 10 weeks). Higher scores indicate better visuospatial and memory performance.)
- DST(Change in DST scores from baseline to post 30 sessions (up to approximately 10 weeks). Higher scores indicate better performance.)
- 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.)
- 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.)
研究者
Yong-il Shin
Professor
Pusan National University Yangsan Hospital
研究点 (1)
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