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

Not Applicable

Completed

• Conditions: Increased Intracranial Pressure Disorders
• Interventions: Other: Infusion

• Registration Number: NCT01776801
• Lead Sponsor: University Hospital, Toulouse

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.

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2011-05
• Study Completion: 2011-12
• Study First Submitted: 2013-01-23
• Study First Submitted QC: 2013-01-23
• Study First Posted: 2013-01-28
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-22
• Last Update Posted: 2013-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hydrocephalus	Infusion	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.

Primary Outcome Measures

Name	Time	Method
change in sympathetic nerve activity after rise in ICP	within few minutes	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

Secondary Outcome Measures

Name	Time	Method
change in hemodynamics after rise in ICP	within few minutes	Assessment of haemodynamics; 1. Cerebral haemodynamics. using Transcranial doppler; 2. Systemic haemodynamics measured with photoplethysmography

Trial Locations

Locations (3)

University Hospital; 🇫🇷 Toulouse, France

University Hospital of Toulouse; 🇫🇷 Toulouse, France

University Hospital Toulouse; 🇫🇷 Toulouse, France