Characterisation of Neuropsychological and Motoric Performance in Patients With Hyponatremia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01879774
Recruitment Status : Recruiting
First Posted : June 18, 2013
Last Update Posted : May 10, 2018
Information provided by (Responsible Party):
Volker Burst, University of Cologne

Brief 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.

Condition or disease Intervention/treatment Phase
Hyponatremia Other: Neuropsychological and motoric tests Not Applicable

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?

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Characterisation of Neuropsychological and Motoric Performance in Patients With Hyponatremia
Actual Study Start Date : June 2012
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : February 2019

Arm Intervention/treatment
Neuropsychological and motoric tests
Neuropsychological and motoric tests are conducted.
Other: Neuropsychological and motoric tests

Evaluation before and after therapy of hyponatremia

  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

Primary Outcome Measures :
  1. Assessment of Performance in individual tests [ Time Frame: Change in individual tests at Baseline and at the earliest 48 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Men and women 18 years of age or older
  • Hyponatremia with serum sodium < 130 mmol/l

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01879774

Contact: Volker Burst, MD +49 221 478 86285
Contact: Torsten Kubacki, MD

University of Cologne Recruiting
Cologne, Germany, 50937
Principal Investigator: Volker Burst, MD         
Sub-Investigator: Torsten Kubacki, MD         
Sub-Investigator: Marco Witthus, MD         
Sub-Investigator: Franziska Grundmann, MD         
Dipartimento di Scienze Biomediche, Sperimentali e Cliniche Mario Serio Recruiting
Firenze, Italy, 50139
Contact: Alessandro Peri, Associate Professor         
Principal Investigator: Alessandro Peri, Associate Professor         
Hospital Universitario Clinico San Carlos Recruiting
Madrid, Spain, 28040
Contact: Isabelle Runkle de la Vega, MD         
Principal Investigator: Isabelle Runkle de la Vega, MD         
Sponsors and Collaborators
University of Cologne
Principal Investigator: Volker Burst, MD University Hospital of Cologne

Responsible Party: Volker Burst, Principal Investigator, University of Cologne Identifier: NCT01879774     History of Changes
Other Study ID Numbers: 002
First Posted: June 18, 2013    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: May 2018

Keywords provided by Volker Burst, University of Cologne:

Additional relevant MeSH terms:
Water-Electrolyte Imbalance
Metabolic Diseases