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临床试验/NCT06916260
NCT06916260招募中不适用

Light Therapy Intervention in Individuals With Parkinson's Disease

University of Delaware2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年4月4日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
2
主要终点
cognitive symptom improvement

研究概览

简要总结

The study looks to investigate the effects that light therapy delivered to the frontal cortex could have on Parkinson's disease related symptoms ( both cognitive and motor). The therapy is a non invasive technique that deliverers low level wavelength light to the front part of the head for 12 minutes. for this study the therapy will be done 3 times a week for 6 weeks. To measure the potential effects on the therapy in Parkinson symptoms, we will do a set of cognitive and motor test before and after the intervention to measure any changes as well as control for any potential markers such as age, sex, disease level, medication and exercise.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of Parkinson disease

排除标准

  • Participants who are unable to comply with study visit/testing requirements (e.g.
  • participants who cannot go off PD medication for the pre-, post-, and 3-month assessments).
  • Participants who are unable to provide consent.
  • Participants with a Deep Brain Stimulation (DBS) device.
  • Participants who have a history of a psychiatric disorder
  • Participants with PD who have other concurrent movement/neurological conditions, including dystonia, dementia, epilepsy etc.
  • Participants with a clinical diagnosis of PD that is not considered primary (e.g.
  • vascular parkinsonism) or participants where an atypical form of parkinsonism is suspected (e.g., progressive supranuclear palsy, multiple system atrophy).
  • Participants with a history of cancer (whether treated with chemotherapy and/or radiotherapy or not).
  • Participants with a history of a recent concussion or any facial, neck, or head injury within the last 6 months. UD IRB Approved: 03/12/2025 IRBNet ID#: 2277769-2 I/C from Rev. 01/2024 Page 3 of 10 Participant's Initial's ________
  • Known injury or disease that might interfere with motor function in the proposed experiments (e.g., stroke, traumatic brain injury, extrapyramidal dysfunction, neuromuscular disease, orthopedic problems that impair movement).
  • Participants with a history of photosensitivity.
  • Participants who are not able to walk unassisted for 2 minutes

结局指标

主要结局

cognitive symptom improvement

时间窗: Done immediately before (pre test) and after (post test) intervention lasting about 1 hour. The intervention lasts about 6 weeks, so in between the pre and post tests there will be about a 6 week period.

The investigators want to asses whether light therapy has a positive effect on reducing the cognitive symptoms related with PD, such as loss of short term memory, attention and processing speed. This will be measured using a set of tests and questioners (i.e MoCa, NIH cognitive battery, brief Test of attention (BTA)). Performance on these tests and questioners, which measure diverse aspects of cognition, will be compared before and after the intervention to establish if there is a positive effect of the therapy on any aspect of cognition. The intervention will last a total of 6 weeks right after the completion of the pre intervention assessment. after the completion of the 6 weeks of intervention therapy, the pre test will be conducted and cognitive measure changes will be recorded.

motor symptoms

时间窗: Done immediately before (pre test) and after(post test) intervention lasting about 1 hour. The intervention lasts 6 weeks, so there is about a 6 week period in between the two sessions ( pre and post)

The investigators want to asses whether light therapy has a positive effect on reducing the motor symptoms related with PD, such as changes in gait, tremors, and slowing of movement. This will be measured using a set of tests and questioners (i.e MDSUPDRS, Dual task walking, APDM motion capture over a set of tests). Performance on these tests and questioners, which measure diverse aspects of motor capabilities, will be compared before (pre test) and after (post tests) the intervention to establish if there is a positive effect of the therapy on any aspect of motor control and movement. The intervention will last a total of 6 weeks, done right after the completion of the pre intervention assessment. after the completion of the 6 weeks of intervention therapy, the pre test will be conducted and any changes in motor measures will be recorded.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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