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Completed

NCT Number: NCT01776801

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

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.

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Key information

Conditions

Increased Intracranial Pressure Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Toulouse, Toulouse, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • psychiatric problems
  • severe cognitive decline

Treatment and study plan

Infusion

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.

Primary outcomes

  1. change in sympathetic nerve activity after rise in ICP

    Time frame: within few minutes

    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 outcomes

  1. change in hemodynamics after rise in ICP

    Time frame: within few minutes

    Assessment of haemodynamics

    • Cerebral haemodynamics. using Transcranial doppler
    • Systemic haemodynamics measured with photoplethysmography

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Acronym: CESNA

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jan 28, 2013
Registry last updated
Feb 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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