Assessment of Autonomic Neuronal Changes During Moderate Rise of Intracranial Pressure in Human (CESNA)
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.
|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|
- 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.
- microneurography to assess the muscle sympathetic nerve activity
- measurement of the plasma level changes of noradrenaline
- power spectral analysis of heart rate and arterial blood pressure
- change in hemodynamics after rise in ICP [ Time Frame: within few minutes ] [ Designated as safety issue: No ]
Assessment of haemodynamics
- Cerebral haemodynamics. using Transcranial doppler
- Systemic haemodynamics measured with photoplethysmography
|Study Start Date:||January 2009|
|Study Completion Date:||December 2011|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
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.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01776801
|University Hospital of Toulouse|
|Toulouse, France, 31059|
|University Hospital Toulouse|
|Toulouse, France, 31059|
|Principal Investigator:||Eric SCHMIDT, MD PhD||University Hospital, Toulouse|