NCT01776801

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2009

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 23, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 28, 2013

Completed
Last Updated

February 25, 2013

Status Verified

February 1, 2013

Enrollment Period

2.3 years

First QC Date

January 23, 2013

Last Update Submit

February 22, 2013

Conditions

Increased Intracranial Pressure Disorders

Keywords

intracranial baroreflex

Outcome Measures

Primary Outcomes (1)

  • change in sympathetic nerve activity after rise in ICP

    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

    within few minutes

Secondary Outcomes (1)

  • change in hemodynamics after rise in ICP

    within few minutes

Study Arms (1)

Hydrocephalus

EXPERIMENTAL

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.

Other: Infusion

Interventions

InfusionOTHER

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.

Hydrocephalus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • psychiatric problems
  • severe cognitive decline

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University Hospital of Toulouse

Toulouse, France, 31059, France

Location

University Hospital Toulouse

Toulouse, 31059, France

Location

University Hospital

Toulouse, France

Location

Study Officials

  • Eric SCHMIDT, MD PhD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2013

First Posted

January 28, 2013

Study Start

January 1, 2009

Primary Completion

May 1, 2011

Study Completion

December 1, 2011

Last Updated

February 25, 2013

Record last verified: 2013-02

Locations

FR(3)