Increased Intracranial Pressure DisordersCESNANCT01776801
Assessment of Autonomic Neuronal Changes During Moderate Rise of Intracranial Pressure in Human
A study testing Infusion in people with Increased Intracranial Pressure Disorders, run by University Hospital, Toulouse at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Increased Intracranial Pressure Disorders
- What is being tested?
- Infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 3 sitesFrance
- Study dates
- Jan 2009to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient suspect of hydrocephalus with gait problems, urine incontinence and mild cognitive impairment.
- signed consent
Who cannot join
- psychiatric problems
- severe cognitive decline
Trial locations and contacts
3 sites in 1 country.
France3 sites
University Hospital of Toulouse
Toulouse, France, 31059
University Hospital Toulouse
Toulouse, 31059
University Hospital
Toulouse
About this study
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.
Read the 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.
- Being tested
- Infusion
- Keywords
- intracranial baroreflex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in sympathetic nerve activity after rise in ICP
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
Measured: within few minutes
Secondary outcomes (1)
change in hemodynamics after rise in ICP
Assessment of haemodynamics
- Cerebral haemodynamics. using Transcranial doppler
- Systemic haemodynamics measured with photoplethysmography
Measured: within few minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2013 (estimated)
- Study startJan 2009
- Primary completionMay 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Increased Intracranial Pressure DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric SCHMIDT, MD PhD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01776801
- Sponsor's protocol ID
- 07 299 03
- Acronym
- CESNA
- Status last verified
- Feb 2013
- First submitted
- 23 Jan 2013
- Last updated
- 25 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Autonomic Neuronal Changes During Moderate Rise of Intracranial Pressure in Human
- ClinicalTrials.gov ID
- NCT01776801
- Acronym / sponsor ID
- CESNA / 07 299 03
- Keywords
- intracranial baroreflex
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- May 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 28 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hydrocephalus | Experimental | Other: InfusionPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patient suspect of hydrocephalus with gait problems, urine incontinence and mild cognitive impairment.
- signed consent
Key exclusion criteria (2 listed)
- psychiatric problems
- severe cognitive decline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InfusionInfusion 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. | Other | Hydrocephalus |
Primary outcome
change in sympathetic nerve activity after rise in ICP
Time frame: 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
1 secondary outcome
change in hemodynamics after rise in ICP
Time frame: within few minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric SCHMIDT, MD PhD principal investigator
University Hospital, Toulouse
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infusion in people with Increased Intracranial Pressure Disorders, run by University Hospital, Toulouse at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in sympathetic nerve activity after rise in ICP (time frame: within few minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2013.