Characterisation of Neuropsychological and Motoric Performance in Patients With Hyponatremia

May 24, 2022 updated by: Volker Burst, University of Cologne
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

189

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Cologne, Germany, 50937
        • University of Cologne
  • Italy
      • Firenze, Italy, 50139
        • Dipartimento di Scienze Biomediche, Sperimentali e Cliniche Mario Serio
  • Spain
      • Madrid, Spain, 28040
        • Hospital Universitario Clinico San Carlos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Patients with hyponatremia
Neuropsychological and motoric tests are conducted in patients with hyponatremia.
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)
OTHER: Patients with normal serum sodium
Neuropsychological and motoric tests are conducted in patients with normal serum sodium.
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of Performance in individual tests
Time Frame: Change in individual tests at Baseline and at least 48 hours after first assessment
Change in individual tests at Baseline and at least 48 hours after first assessment

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment of cerebral basal activity in fMRI during hyponatremia and after its compensation
Time Frame: Change in fMRI from baseline and at least 48 hours after first assessment
Change in fMRI from baseline and at least 48 hours after first assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cologne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2012

Primary Completion (ACTUAL)

January 1, 2022

Study Completion (ACTUAL)

April 1, 2022

Study Registration Dates

First Submitted

April 23, 2013

First Submitted That Met QC Criteria

June 13, 2013

First Posted (ESTIMATE)

June 18, 2013

Study Record Updates

Last Update Posted (ACTUAL)

May 25, 2022

Last Update Submitted That Met QC Criteria

May 24, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 002 (University of CT Health Center)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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