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

NCT ID: NCT01776801

Last Updated: 2013-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-12-31

Brief Summary

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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

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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.

Conditions

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Increased Intracranial Pressure Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Infusion

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* psychiatric problems
* severe cognitive decline
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric SCHMIDT, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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University Hospital of Toulouse

Toulouse, France, France

Site Status

University Hospital Toulouse

Toulouse, , France

Site Status

University Hospital

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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07 299 03

Identifier Type: -

Identifier Source: org_study_id

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