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

Increased Intracranial Pressure Disorders Clinical Trial

— CESNA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01776801
• Other study ID #: 07 299 03
• Status: Completed
• Phase: N/A
• First received: January 23, 2013
• Last updated: February 22, 2013
• Start date: January 2009
• Est. completion date: December 2011

Study information

• Verified date: February 2013
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

• signed consent

Exclusion Criteria:

• psychiatric problems

• severe cognitive decline

Study Design

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Increased Intracranial Pressure Disorders
• Intracranial Hypertension

Intervention

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.

Locations

Country	Name	City	State
France	University Hospital	Toulouse
France	University Hospital of Toulouse	Toulouse
France	University Hospital Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in sympathetic nerve activity after rise in ICP	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	within few minutes	No
Secondary	change in hemodynamics after rise in ICP	Assessment of haemodynamics; Cerebral haemodynamics. using Transcranial doppler; Systemic haemodynamics measured with photoplethysmography	within few minutes	No