ACTRN12621001722886已完成未知
Evaluating the safety and efficacy of a transcranial photobiomodulation therapy device on the clinical signs and symptoms, and quality of life of Parkinson's disease patients
SYMBYX Biome0 个研究点目标入组 40 人开始时间: 2021年12月16日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 60 Years 至 85 Years（—）
- 性别
- All
入选标准
- •Females and males diagnosed with Idiopathic Parkinson's disease (by UK Brain Bank Criteria) with Modified Hoen & Yahr staging of I - III during ON periods, and with 3 or more weeks of stable anti-Parkinson's disease medication.
- •Sufficient space at home (around 9 m2) to be able to perform motor assessments; Stable and sufficiently fast home-based internet connection for uninterrupted video calls and video conferencing; Knowledge (self or carer) of using a phone and/or tablet applications on either IOS or Android platforms
排除标准
- •Participants with the following will be excluded from the study, if they: are incapable of self-care; have cognitive impairment with a MoCa score of <24; history of significant psychotic episode(s) within the last 12-months; history of suicidal ideation or attempted suicide within the last 12-months; take potentially photosensitising medication, especially imipramine, hypericum, phenothiazine, lithium, chloroquine, hydrochlorothiazide, or tetracycline; have a history of structural brain disease, active epilepsy, stroke or acute illness, factors affecting gait performance and stance such as severe joint disease, orthopaedic injuries, weakness, peripheral neuropathy with proprioceptive deficits, severe peripheral vascular occlusive disease, severe musculoskeletal disorders, uncorrected vision, vestibular problems or other severe conditions (such as those that preclude the use of photobiomodulation therapy, that places the patient at risk during evaluation of their Parkinson's disease, or interferes with the evaluation of their Parkinson's disease); have cardiac disease; are currently participating other trials regarding the treatment of Parkinson's disease, such as advanced therapies (including Duodopa, Apomorphine, Deep Brain Stimulation).
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