NCT01879774

Characterisation of Neuropsychological and Motoric Performance in Patients With Hyponatremia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 189 (actual)
• Sponsor: University of Cologne · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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: 1. Which cognitive, motoric and psychological functions are impaired due to hyponatremia? 2. Is there a correlation between the extend of hyponatremia and the different test results? 3. 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.

Conditions

• Hyponatremia

Interventions

Type	Name	Description
OTHER	Neuropsychological and motoric tests	1. Neuropsychological tests * Mini Mental Status Test * Dem-Tect * Rey-Osterrieth Complex Figure Test * Trailmaking Test * Beck Depression Inventory * d2-R (optional) 2. Motoric tests * modified UPDRS (Unified Parkinson Disease Rating Scale) Part III * Timed-up-and-go Test * Halstead Fingertapping Test * AIMS (Abnormal involuntary movement scale) 3. EEG (only in patients with hyponatremia) 4. MRI (only in patients with hyponatremia)

Timeline

• Start date: 2012-06-01
• Primary completion: 2022-01-01
• Completion: 2022-04-01
• First posted: 2013-06-18
• Last updated: 2022-05-25

Locations

3 sites across 3 countries: Germany, Italy, Spain