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

Primary Purpose

Increased Intracranial Pressure Disorders

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Infusion

About this trial

This is an interventional basic science trial for Increased Intracranial Pressure Disorders focused on measuring intracranial baroreflex

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

psychiatric problems
severe cognitive decline

Sites / Locations

University Hospital of Toulouse
University Hospital Toulouse
University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hydrocephalus

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

change in hemodynamics after rise in ICP

Assessment of haemodynamics Cerebral haemodynamics. using Transcranial doppler Systemic haemodynamics measured with photoplethysmography

Full Information

NCT ID

NCT01776801

First Posted

January 23, 2013

Last Updated

February 22, 2013

Sponsor

University Hospital, Toulouse

1. Study Identification

Unique Protocol Identification Number

NCT01776801

Brief Title

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

Acronym

CESNA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Completed

Study Start Date

January 2009 (undefined)

Primary Completion Date

May 2011 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Toulouse

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Increased Intracranial Pressure Disorders

Keywords

intracranial baroreflex

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hydrocephalus

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Infusion

Intervention Description

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.

Primary Outcome Measure Information:

Title

change in sympathetic nerve activity after rise in ICP

Description

Time Frame

within few minutes

Secondary Outcome Measure Information:

Title

change in hemodynamics after rise in ICP

Description

Assessment of haemodynamics Cerebral haemodynamics. using Transcranial doppler Systemic haemodynamics measured with photoplethysmography

Time Frame

within few minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eric SCHMIDT, MD PhD

Organizational Affiliation

University Hospital, Toulouse

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital of Toulouse

City

Toulouse

ZIP/Postal Code

31059

Country

France

Facility Name

University Hospital Toulouse

City

Toulouse

ZIP/Postal Code

31059

Country

France

Facility Name

University Hospital

City

Toulouse

Country

France

12. IPD Sharing Statement

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

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