Double-blind, Randomized Controlled Trial to Demonstrate Efficacy of Celeste® Specialized Phototherapy in Treating Parkinson's Disease.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 350
- 试验地点
- 2
- 主要终点
- Parkinson's Disease Questionnaire-39 (PDQ-39)
研究概览
简要总结
This is a pivotal study to determine whether light therapy can improve non-motor and motor function in Parkinson's disease, on top of current best medical treatment.
详细描述
Six month double blind, randomized controlled study with virtual clinic visits at baseline, week 13 and week 26. The Celeste specialized phototherapy device is similar to a tablet with a stand that allows the device to be angled towards the participant's face. The light is to be used each evening in the home for 1 hour, while the participant watches TV, eats dinner, reads, etc. The primary outcome measure is the Parkinson's Disease Questionnaire-39 Summary Index (PDQ-39SI). The PDQ-39 is a patient-reported, quality of life scale. The key secondary endpoint is Parts 1 and 2 of the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS). The MDS-UPDRS Parts 1 and 2 measure non-motor and motor function in Parkinson's. Participants will be assessed via online videoconferences.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Research suggests that certain wavelengths of light are more effective in treating Parkinson's, which means this therapeutic light device does not need to be nearly as bright as traditional light therapy. This study will test a light therapy device (Celeste® specialized light therapy device). We are testing two devices in this study: an active device which has these special wavelengths, and a control device which does not have the special wavelengths. Both lights look the same, and it is not possible to tell which light has the effective wavelength by looking at it. No one involved in the study (patients, families, doctors, investigative staff) knows which type of light therapy each person receives. A Device Technician, separate from the trial, will assist the participants in the device setup. Participants will be instructed not to disclose any aspects of their device. All study staff will be masked.
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of Parkinson's disease as determined by the study PI, in keeping with the UK PD Society Brain Bank Criteria for the Diagnosis of PD
- •Responsiveness to dopaminergic medication, as judged by the rater, and have been using treatment for at least the past 1 year
- •Relatively good eyesight as attested to by participants (Corrective lenses of at least 20/60)
- •Stable levodopa and other anti-PD medications for at least 28 days prior to screening -
排除标准
- •Diagnosis of an atypical Parkinsonian syndrome
- •Significant OFF state or bothersome dyskinesias that in the judgment of the rater, would interfere with participation in the study.
- •An anticipated need for a change in dopamine replacement therapy, concomitant medications, OTC/supplements, or other alternative therapies during the participant's involvement in the investigation
- •History of previous light therapy use for PD
结局指标
主要结局
Parkinson's Disease Questionnaire-39 (PDQ-39)
时间窗: 26 weeks
The Parkinson's Disease Questionnaire-39 (PDQ-39) is a patient-reported rating scale for quality of life in Parkinson's disease. Respondents affirm if they have experienced problems due to their disease using a five point scale from never (0 points) to always (4 points, or worse) in doing common activities. The PDQ-39 is comprised of 8 domains: mobility, emotion, activities of daily living, cognition, stigma, social support, communication, bodily discomfort. Total possible range of scores = 0 - 156, with higher scores representing worse severity.
次要结局
- Movement Disorders Society-Unified Parkinson's Disease Rating Scale, Sum or Parts 1+2(26 weeks)