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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01776801

Acronym

CESNA

Enrollment

Registered

2013-01-28

Start date

2009-01-31

Completion date

2011-12-31

Last updated

2013-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Increased Intracranial Pressure Disorders

Keywords

intracranial baroreflex

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.

Interventions

OTHERInfusion

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026