DRKS00032840招募中不适用
Multiorgan complexity in Friedreich Ataxia - FACROSS
niklinik RWTH Aachen0 个研究点目标入组 150 人开始时间: 2023年12月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- one 至 one（—）
- 性别
- All
入选标准
- •Participants with Friedreich ataxia will be recruited to the study if they meet the following inclusion criteria:
- •-genetically confirmed diagnosis of Friedreich ataxia
- •-written informed consent provided
- •For underage patients who are eligible for the study because of an early disease onset, they and the parent/ legal guardian must sign the informed consent form.
- •Persons who are not legally competent require the informed consent of their legal guardian.
- •Healthy controls will be recruited to the study if they meet the following inclusion criteria:
- •-written informed consent provided
- •Controls may be family members or recruited elsewhere, heterozygous GAA expansion carriers are allowed
- •For underage controls who are eligible for the study they and the parent/ legal guardian must sign the informed consent form
排除标准
- •Participants with Friedreich ataxia will be excluded from participating in the study if they meet any of the following criteria:
- •-not legally competent and no parent/ guardian to provide written informed consent
- •-no genetically confirmed diagnosis of Friedreich ataxia
- •-acute or ongoing medical or other conditions that would interfere with the conduct and assessments of the study
- •Controls will be excluded from participating in the study if they meet any of the following criteria:
- •-unable to provide written informed consent
- •-diagnosed with a relevant ongoing psychiatric or neurological condition
- •-acute or ongoing medical or other conditions that would interfere with the conduct and assessments of the study
- •-Pregnancy
- •For participants who will undergo MRI (optional): Any contraindications to MRI such as, but not limited to cardiac pacemaker, implanted cardiac defibrillator, aneurysm clips, carotid artery vascular clamp, neurostimulator, implanted drug infusion devices, metal fragments or foreign objects in the eyes, skin or body, bone growth/fusion stimulator, cochlear, otologic implant, severe claustrophobia or any condition that would counter indicate an MRI scan.
- •For participants undergoing spinal and/or kinematic analysis the following exclusion criteria apply: implanted pacemaker, severe obesity (BMI > 35) or pregnancy
- •For participants undergoing an adipose tissue biopsy the following exclusion criteria apply: pregnancy, use of anticoagulants or antiplatelet therapy (except monotherapy with low-dose Aspirin), hypersensitivity to local anesthesia, or a skin rash of the abdominal region
研究者
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