Assessment of Autonomic Neuronal Changes During Moderate Rise of Intracranial Pressure in Human (CESNA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT01776801
First received: January 23, 2013
Last updated: February 22, 2013
Last verified: February 2013
  Purpose

The purpose of this project is to determine during moderate rise of intracranial pressure (ICP) in awake patient, the change in autonomic function and its influence on cerebral and systemic haemodynamics.


Condition Intervention
Increased Intracranial Pressure Disorders
Other: Infusion

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Assessment of Autonomic Neuronal Changes During Moderate Rise of Intracranial Pressure in Human

Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • change in sympathetic nerve activity after rise in ICP [ Time Frame: within few minutes ] [ Designated as safety issue: No ]

    Assessment of autonomic neural function using.

    1. microneurography to assess the muscle sympathetic nerve activity
    2. measurement of the plasma level changes of noradrenaline
    3. power spectral analysis of heart rate and arterial blood pressure


Secondary Outcome Measures:
  • change in hemodynamics after rise in ICP [ Time Frame: within few minutes ] [ Designated as safety issue: No ]

    Assessment of haemodynamics

    1. Cerebral haemodynamics. using Transcranial doppler
    2. Systemic haemodynamics measured with photoplethysmography


Enrollment: 10
Study Start Date: January 2009
Study Completion Date: December 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hydrocephalus
Patients suffering of hydrocephalus (cognitive impairment, gait disturbance, urinary incontinence and enlargement of the ventricles) require for clinical purpose infusion studies i.e. injection of mock cerebrospinal fluid (CSF) in the sub arachnoid space to artificially increase ICP. We aim at using infusion studies as a indirect tool to assess whether a moderate increase in ICP has any influence on haemodynamics.
Other: Infusion
Infusion studies are performed in daily clinical routine to measure cerebrospinal fluid resistance outflow. During this test ICP is slowly and securely raised. Investigators plan to analyze what are the consequences of this ICP rise in terms of autonomic system and hemodynamics.

Detailed Description:

From preliminary data, we know that changes in ICP influences both systemic and cerebral haemodynamics, introducing the concept of intracranial baroreflex We have to i) confirm the presence of this intracranial baroreflex, ii) analyze the changes in autonomic function during moderate rise in intracranial pressure (ICP) in human, and iii) correlate the changes in cerebral and systemic haemodynamics with autonomic function.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patient suspect of hydrocephalus with gait problems, urine incontinence and mild cognitive impairment.
  • signed consent

Exclusion Criteria:

  • psychiatric problems
  • severe cognitive decline
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01776801

Locations
France
University Hospital
Toulouse, France
University Hospital Toulouse
Toulouse, France, 31059
University Hospital of Toulouse
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Eric SCHMIDT, MD PhD University Hospital, Toulouse
  More Information

No publications provided

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01776801     History of Changes
Other Study ID Numbers: 07 299 03
Study First Received: January 23, 2013
Last Updated: February 22, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by University Hospital, Toulouse:
intracranial baroreflex

Additional relevant MeSH terms:
Intracranial Hypertension
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on October 19, 2014