Characterisation of Neuropsychological and Motoric Performance in Patients With Hyponatremia

  • STATUS
    Recruiting
  • End date
    Dec 14, 2022
  • participants needed
    190
  • sponsor
    University of Cologne
Updated on 14 May 2021
serum sodium

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.

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.

Details
Condition Hyponatremia, Low Blood Sodium (Hyponatremia)
Treatment Neuropsychological and motoric tests
Clinical Study IdentifierNCT01879774
SponsorUniversity of Cologne
Last Modified on14 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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)

Exclusion Criteria

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
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