Characterisation of Neuropsychological and Motoric Performance in Patients With Hyponatremia
Primary Purpose
Hyponatremia
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Neuropsychological and motoric tests
Sponsored by
About this trial
This is an interventional diagnostic trial for Hyponatremia focused on measuring Hyponatremia
Eligibility Criteria
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
Sites / Locations
- University of Cologne
- Dipartimento di Scienze Biomediche, Sperimentali e Cliniche Mario Serio
- Hospital Universitario Clinico San Carlos
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Patients with hyponatremia
Patients with normal serum sodium
Arm Description
Neuropsychological and motoric tests are conducted in patients with hyponatremia.
Neuropsychological and motoric tests are conducted in patients with normal serum sodium.
Outcomes
Primary Outcome Measures
Assessment of Performance in individual tests
Secondary Outcome Measures
Assessment of cerebral basal activity in fMRI during hyponatremia and after its compensation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01879774
Brief Title
Characterisation of Neuropsychological and Motoric Performance in Patients With Hyponatremia
Official Title
Characterisation of Neuropsychological and Motoric Performance in Patients With Hyponatremia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
June 2012 (Actual)
Primary Completion Date
January 2022 (Actual)
Study Completion Date
April 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cologne
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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:
Which cognitive, motoric and psychological functions are impaired due to hyponatremia?
Is there a correlation between the extend of hyponatremia and the different test results?
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyponatremia
Keywords
Hyponatremia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
189 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with hyponatremia
Arm Type
Other
Arm Description
Neuropsychological and motoric tests are conducted in patients with hyponatremia.
Arm Title
Patients with normal serum sodium
Arm Type
Other
Arm Description
Neuropsychological and motoric tests are conducted in patients with normal serum sodium.
Intervention Type
Other
Intervention Name(s)
Neuropsychological and motoric tests
Intervention Description
Neuropsychological tests
Mini Mental Status Test
Dem-Tect
Rey-Osterrieth Complex Figure Test
Trailmaking Test
Beck Depression Inventory
d2-R (optional)
Motoric tests
modified UPDRS (Unified Parkinson Disease Rating Scale) Part III
Timed-up-and-go Test
Halstead Fingertapping Test
AIMS (Abnormal involuntary movement scale)
EEG (only in patients with hyponatremia)
MRI (only in patients with hyponatremia)
Primary Outcome Measure Information:
Title
Assessment of Performance in individual tests
Time Frame
Change in individual tests at Baseline and at least 48 hours after first assessment
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Volker Burst, MD
Organizational Affiliation
University Hospital of Cologne
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cologne
City
Cologne
ZIP/Postal Code
50937
Country
Germany
Facility Name
Dipartimento di Scienze Biomediche, Sperimentali e Cliniche Mario Serio
City
Firenze
ZIP/Postal Code
50139
Country
Italy
Facility Name
Hospital Universitario Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
12. IPD Sharing Statement
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Characterisation of Neuropsychological and Motoric Performance in Patients With Hyponatremia
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