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Effects of remote ischemic conditioning on sleep complaints in Parkinson's disease-rationale, design, and protocol for a randomized controlled study

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机构: [1]Capital Med Univ, Beijing Luhe Hosp, Dept Neurol, Beijing, Peoples R China [2]Capital Med Univ, Xuanwu Hosp, Dept Neurol, Beijing, Peoples R China [3]Wayne State Univ, Sch Med, Dept Neurosurg, Detroit, MI 48201 USA
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关键词: remote ischemic adaptation Parkinson's disease excessive daytime sleepiness non-motor symptoms non-pharmacologic treatment

摘要:
Objective: Sleep disturbances are common non-motor symptoms of Parkinson's disease. The symptoms affect the quality of patients' life by impeding normal sleep cycles and causing excessive daytime sleepiness. Remote Ischemic Conditioning (RIC) is a therapy often used for ischemic stroke patients to minimize infarct size and maximize post-stroke neurological function. Animal experiments have shown that RIC plays a protective role for retinal ganglion cells and other critical areas of the brain of Parkinson's disease. However, whether RIC improves excessive daytime sleepiness (EDS) for patients with Parkinson's disease remains to be determined. Methods: This is a single-center, double-blind, and randomized controlled trial, which includes patients with Parkinson's disease with EDS. All recruited patients will be randomly assigned either to the RIC or the control group (i.e., sham-RIC) with 20 patients in each group. Both groups receive RIC or sham-RIC treatment once a day for 28 days within 24 h of enrollment. Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Parkinson Disease Sleep Scale-2 (PDSS-2), Parkinson's Disease Questionnaire39 (PDQ39) score scales, and adverse events, such as inability to tolerate the treatment leading to suspension of the study or objective signs of tissue or neurovascular injury caused by RIC and/or sham-RIC are evaluated at 7, 14, 28, and 90 days after enrollment. Results: The primary goal of this study is to assess the feasibility of the treatments in patients with Parkinson's disease by measuring serious RIC-related adverse events and any reduced incidence of adverse events during the trial and to study potential efficacy, improvement of patients' excessive daytime sleepiness, quality of life-based on ESS, PSQI, PDSS-2, and PDQ39 scores. The secondary goal is to confirm the safety of the treatments. Conclusion: This study is a prospective randomized controlled trial to determine the safety, feasibility, and potential efficacy of RIC for patients with Parkinson's disease associated with EDS.

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基金编号: 82072549 81871838 LHYY2021-LC08

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出版当年[2021]版:
大类 | 3 区 医学
小类 | 3 区 临床神经病学 3 区 神经科学
最新[2025]版:
大类 | 3 区 医学
小类 | 3 区 临床神经病学 3 区 神经科学
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出版当年[2020]版:
Q2 NEUROSCIENCES Q2 CLINICAL NEUROLOGY
最新[2023]版:
Q2 CLINICAL NEUROLOGY Q3 NEUROSCIENCES

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第一作者机构: [1]Capital Med Univ, Beijing Luhe Hosp, Dept Neurol, Beijing, Peoples R China
通讯作者:
通讯机构: [1]Capital Med Univ, Beijing Luhe Hosp, Dept Neurol, Beijing, Peoples R China [3]Wayne State Univ, Sch Med, Dept Neurosurg, Detroit, MI 48201 USA
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