PDF(Pubmed)
Abstract：
UNASSIGNED: Bipolar disorders (BD) is a common, chronic and disabling psychiatric condition. In addition to being characterized by significant clinical heterogeneity, notable disturbances of sleep and cognitive function are frequently observed in all phases of the disease. Currently, there is no readily available biomarker in current clinical practice to help diagnose or predict the disease course. Thus, identification of biomarkers in BD is today a major challenge. In this context, the study of electrophysiological biomarkers based on electroretinogram (ERG) measurements in BD seems highly promising. The BiMAR study aims to compare electrophysiological data measured with ERG between a group of euthymic patients with BD and a group of healthy control subjects. Secondarily, we will also describe the existing potential relationship between clinical, sleep and neuropsychological phenotypes of patients and electrophysiological data.
UNASSIGNED: The BiMAR study is a comparative and monocentric study carried out at the Expert Center for BD in Nancy, France. In total, 70 euthymic adult patients with BD and 70 healthy control subjects will be recruited. Electrophysiological recordings with ERG and electroencephalogram (EEG) will be performed with a virtual reality headset after a standardized clinical evaluation to all participants. Then, an actigraphic monitoring of 21 consecutive days will be carried out. At the end of this period a neuropsychological evaluation will be performed during a second visit. The primary outcome will be electrophysiological measurements with ERG flash and pattern. Secondary outcomes will be EEG data, sleep settings, clinical and neuropsychological assessments. For patients only, a complementary ancillary study, carried out at the University Hospital of Nancy, will be proposed to assess the retinal structure and microvascularization using Optical Coherence Tomography. Recruitment started in January 2022 and will continue until the end of July 2023.
UNASSIGNED: The BiMAR study will contribute to identifying candidate ERG electrophysiological markers for helping the diagnosis of BD and identify subgroups of patients with different clinical profiles. Eventually, this would allow earlier diagnosis and personalized therapeutic interventions.
UNASSIGNED: The study is registered at Clinicaltrials.gov, NCT05161546, on 17 December 2021 (https://clinicaltrials.gov/ct2/show/NCT05161546).
UNASSIGNED: The BiMAR study is a comparative and monocentric study carried out at the Expert Center for BD in Nancy, France. In total, 70 euthymic adult patients with BD and 70 healthy control subjects will be recruited. Electrophysiological recordings with ERG and electroencephalogram (EEG) will be performed with a virtual reality headset after a standardized clinical evaluation to all participants. Then, an actigraphic monitoring of 21 consecutive days will be carried out. At the end of this period a neuropsychological evaluation will be performed during a second visit. The primary outcome will be electrophysiological measurements with ERG flash and pattern. Secondary outcomes will be EEG data, sleep settings, clinical and neuropsychological assessments. For patients only, a complementary ancillary study, carried out at the University Hospital of Nancy, will be proposed to assess the retinal structure and microvascularization using Optical Coherence Tomography. Recruitment started in January 2022 and will continue until the end of July 2023.
UNASSIGNED: The BiMAR study will contribute to identifying candidate ERG electrophysiological markers for helping the diagnosis of BD and identify subgroups of patients with different clinical profiles. Eventually, this would allow earlier diagnosis and personalized therapeutic interventions.
UNASSIGNED: The study is registered at Clinicaltrials.gov, NCT05161546, on 17 December 2021 (https://clinicaltrials.gov/ct2/show/NCT05161546).
摘要：
未经批准：双相情感障碍（BD）是一种常见的，慢性和致残精神病。除了具有显著的临床异质性特征外，在疾病的所有阶段都经常观察到明显的睡眠和认知功能障碍。目前,在目前的临床实践中，没有可用的生物标志物来帮助诊断或预测疾病进程。因此，识别BD中的生物标志物是当今的主要挑战。在这种情况下，在BD中基于视网膜电图（ERG）测量的电生理生物标志物的研究似乎非常有希望。BiMAR研究旨在比较一组BD患者和一组健康对照受试者之间用ERG测量的电生理数据。其次，我们还将描述临床，患者的睡眠和神经心理表型以及电生理数据。
未经评估：BiMAR研究是在南希BD专家中心进行的一项比较和单中心研究，法国。总的来说,将招募70名患有BD的正常成年患者和70名健康对照受试者。在对所有参与者进行标准化临床评估后，将使用虚拟现实耳机进行ERG和脑电图（EEG）的电生理记录。然后，将进行连续21天的活动监测。在此期间结束时，将在第二次访问中进行神经心理学评估。主要结果将是具有ERG闪光和模式的电生理测量。次要结果将是脑电图数据，睡眠设置,临床和神经心理学评估。仅对患者而言,补充的辅助研究，在南希大学医院进行，将建议使用光学相干断层扫描来评估视网膜结构和微血管形成。招聘始于2022年1月，并将持续到2023年7月底。
UNASSIGNED：BiMAR研究将有助于确定有助于诊断BD的候选ERG电生理标志物，并确定具有不同临床特征的患者亚组。最终,这将允许早期诊断和个性化治疗干预.
未经评估：该研究已在Clinicaltrials.gov注册，NCT05161546，2021年12月17日（https://clinicaltrials.gov/ct2/show/NCT05161546）。
未经评估：BiMAR研究是在南希BD专家中心进行的一项比较和单中心研究，法国。总的来说,将招募70名患有BD的正常成年患者和70名健康对照受试者。在对所有参与者进行标准化临床评估后，将使用虚拟现实耳机进行ERG和脑电图（EEG）的电生理记录。然后，将进行连续21天的活动监测。在此期间结束时，将在第二次访问中进行神经心理学评估。主要结果将是具有ERG闪光和模式的电生理测量。次要结果将是脑电图数据，睡眠设置,临床和神经心理学评估。仅对患者而言,补充的辅助研究，在南希大学医院进行，将建议使用光学相干断层扫描来评估视网膜结构和微血管形成。招聘始于2022年1月，并将持续到2023年7月底。
UNASSIGNED：BiMAR研究将有助于确定有助于诊断BD的候选ERG电生理标志物，并确定具有不同临床特征的患者亚组。最终,这将允许早期诊断和个性化治疗干预.
未经评估：该研究已在Clinicaltrials.gov注册，NCT05161546，2021年12月17日（https://clinicaltrials.gov/ct2/show/NCT05161546）。
