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Characterisation of Neuropsychological and Motoric Performance in Patients With Hyponatremia

This study is currently recruiting participants.
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Verified May 2017 by Volker Burst, University of Cologne
Information provided by (Responsible Party):
Volker Burst, University of Cologne Identifier:
First received: April 23, 2013
Last updated: May 2, 2017
Last verified: May 2017
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 Intervention
Hyponatremia Other: Neuropsychological and motoric tests

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Characterisation of Neuropsychological and Motoric Performance in Patients With Hyponatremia

Further study details as provided by Volker Burst, University of Cologne:

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

Estimated Enrollment: 100
Study Start Date: June 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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?

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

Responsible Party: Volker Burst, Principal Investigator, University of Cologne Identifier: NCT01879774     History of Changes
Other Study ID Numbers: 002
Study First Received: April 23, 2013
Last Updated: May 2, 2017

Keywords provided by Volker Burst, University of Cologne:

Additional relevant MeSH terms:
Water-Electrolyte Imbalance
Metabolic Diseases processed this record on August 18, 2017