Characterisation of Neuropsychological and Motoric Performance in Patients With Hyponatremia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 189
- 试验地点
- 6
- 主要终点
- Assessment of Performance in individual tests
研究概览
简要总结
The aim of this epidemiological study is to characterize the neuropsychological and motoric performance in patients with hyponatremia. Newer studies revealed an association between mild hyponatremia and unstable walking, frequency of falls and risk of a fracture, questioning the paradigm of an "asymptomatic" hyponatremia. Until now, there is no known detailed investigation and characterisation of the cognitive and motoric performance or limitation by this disorder. Therefore this study will investigate patients with hyponatremia on the basis of neuropsychological and neurological tests.
详细描述
Hyponatremia is the most common electrolyte disorder in outpatients and hospitalized patients. The prevalence of hospital-associated hyponatremia is estimated to be up to 40%. Especially mild to moderate hyponatremia (125-136 mmo/l) without apparent symptoms has seldomly been accurately assessed but rather seen as clinically irrelevant. Cognitive limitations, unstable gait and motoric disorders as well as depressive conditions were described in smaller studies and single case reports.
In terms of the question, if a therapeutic influence is also reasonable in slight symptomatic hyponatremia it is necessary to establish an accurate phenotyping of patients with hyponatremia, which quantifies the individual cognitive, motoric and psychological qualities.
Patients with hyponatremia will be examined on the basis of standardized neuropsychological and neurological tests. Following questions are to be answered with this study:
- Which cognitive, motoric and psychological functions are impaired due to hyponatremia?
- Is there a correlation between the extend of hyponatremia and the different test results?
- Is there an intraindividual difference in test results during hyponatremia and normal sodium concentrations?
In addition to clinical testing, functional magnetic resonance imaging (fMRI) will be performed before and after therapy in up to 40 patients with hyponatremia. Functional magnetic resonance imaging (fMRI) is an imaging procedure in which local changes in cerebral oxygen concentration can be used to draw conclusions about brain activity. In connection with the current research project, an initial contribution is to be made in order to close the existing knowledge gap as to whether a functionally-image-morphologically tangible change in cerebral activity can also be depicted non-invasively by means of fMRI during hyponatremia or after its compensation. Another component of cerebral evaluation in this context is volumetry in fMRI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women 18 years of age or older
- •Hyponatremia with serum sodium < 130 mmol/l
- •Men and women with normal serum sodium > 130 mmol/l (control group)
排除标准
- •traumatic cerebral injury, hemorrhagic and ischemic insult as cause of hyponatremia
- •professional or private relationship between subject and the investigators, or dependance on the investigators
- •Placement in an institution based on official orders
- •Patients who are unable to give informed consent
- •Patients with contraindication for MRI investigation
结局指标
主要结局
Assessment of Performance in individual tests
时间窗: Change in individual tests at Baseline and at least 48 hours after first assessment
次要结局
- Assessment of cerebral basal activity in fMRI during hyponatremia and after its compensation(Change in fMRI from baseline and at least 48 hours after first assessment)
研究者
Volker Burst
Principal Investigator
University of Cologne