Characterisation of Neuropsychological and Motoric Performance in Patients With Hyponatremia

NCT01879774 | Completed

• 1 other identifier: 002
• Study Type: interventional
• Target: 189
• Locations: 3 countries
• Sites: 3

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.

Conditions

Hyponatremia

Keywords

Hyponatremia

Outcome Measures

Primary Outcomes (1)

• Assessment of Performance in individual tests

  Change in individual tests at Baseline and at least 48 hours after first assessment

Secondary Outcomes (1)

• Assessment of cerebral basal activity in fMRI during hyponatremia and after its compensation

  Change in fMRI from baseline and at least 48 hours after first assessment

Study Arms (2)

Patients with hyponatremia

OTHER

Neuropsychological and motoric tests are conducted in patients with hyponatremia.

Other: Neuropsychological and motoric tests

Patients with normal serum sodium

OTHER

Neuropsychological and motoric tests are conducted in patients with normal serum sodium.

Other: Neuropsychological and motoric tests

Interventions

Neuropsychological and motoric tests OTHER

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)

Patients with hyponatremia; Patients with normal serum sodium

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (3)

University of Cologne

Cologne, 50937, Germany

Location

Dipartimento di Scienze Biomediche, Sperimentali e Cliniche Mario Serio

Florence, 50139, Italy

Location

Hospital Universitario Clinico San Carlos

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Hyponatremia

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Volker Burst, MD

  University Hospital of Cologne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 23, 2013
• First Posted: June 18, 2013
• Study Start: June 1, 2012
• Primary Completion: January 1, 2022
• Study Completion: April 1, 2022
• Last Updated: May 25, 2022

Record last verified: 2022-05

Locations

IT (1); ES (1); DE (1)