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

January 23, 2013
February 22, 2013
January 2009
May 2011   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01776801 on ClinicalTrials.gov Archive Site
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
change in hemodynamics after rise in ICP [ Time Frame: within few minutes ] [ Designated as safety issue: No ]

Assessment of haemodynamics

  1. Cerebral haemodynamics. using TCD
  2. Systemic haemodynamics measured with photoplethysmography
Not Provided
Not Provided
 
Assessment of Autonomic Neuronal Changes During Moderate Rise of Intracranial Pressure in Human
Assessment of Autonomic Neuronal Changes During Moderate Rise of Intracranial Pressure in Human

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.

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.

Interventional
Not Provided
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Increased Intracranial Pressure Disorders
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.
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.
Intervention: Other: Infusion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
December 2011
May 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • psychiatric problems
  • severe cognitive decline
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01776801
07 299 03
No
University Hospital, Toulouse
University Hospital, Toulouse
Not Provided
Principal Investigator: Eric SCHMIDT, MD PhD University Hospital, Toulouse
University Hospital, Toulouse
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP