HydrocephalusHYDRODIFFNCT05825521
Impact of Cerebral Ventricular Dilatations and Cerebrospinal Fluid Pulsations on Periventricular White Matter in Hydrocephalic Patients
A study testing MRI in people with Hydrocephalus and Cerebral Ventricle, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Hydrocephalus is characterized by excessive accumulation of cerebrospinal fluid (CSF) in the ventricles of the brain. One of the forms of hydrocephalus is called "normal pressure", although one of the main signs is precisely an alteration of the intracranial pressure (ICP), it is here called active hydrocephalus (HA). Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Hydrocephalus, Cerebral Ventricle, Cerebrospinal Fluid
- What is being tested?
- MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 14 Dec 2019to Dec 2023
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For Patients with hydrocephalus:
- Age > 55,
- Ventricular dilation: Evans Index > 0.3;
- Patients with cognitive impairment, and gait disturbances and/or urinary incontinence or a combination of these three symptoms;
- Absence of other neurological diseases that could cause ventriculomegaly, information and non-opposition.
- For Controls:
Show all 13Show fewer
- Age ≥ 55;
- No ventricular dilation: Evans Index < 0.3;
- Individuals who have no neurological or psychiatric disease;
- No neurological deficit.
- No history of neurosurgery or head trauma;
- signed informed consent;
- affiliation to a social security scheme.
Who cannot join
- All patients who have a neurological disease other than active hydrocephalus will be excluded;
- Individuals unable to sign or understand consent;
- Individuals with psychiatric, neurological or medical development;
- Individuals under treatment with psychoactive drugs;
- Individuals who cannot tolerate an MRI examination;
- Any individual with implant, pacemaker, prosthesis and ferromagnetic object
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Amiens
Salouël, 80480
Olivier Baledent, DR, (33)322089520, baledent.olivier@chu-amiens.fr
About this study
Hydrocephalus is characterized by excessive accumulation of cerebrospinal fluid (CSF) in the ventricles of the brain. One of the forms of hydrocephalus is called "normal pressure", although one of the main signs is precisely an alteration of the intracranial pressure (ICP), it is here called active hydrocephalus (HA). Although MRI is the reference radiological modality for the characterization of HA. The Evan's and DESH index are radiological diagnostic criteria based on the dilation and morphology of the CSF compartments. These morphological indices remain insensitive and specific. In recent years, advances in Phase Contrast (MRI-PC) and Diffusion (MRI-DTI) MRI have generated new biomarkers of brain viability. The aim of this study is to characterize by MRI the impact of hydrocephalus on brain fluids and tissues.
- Being tested
- MRI
- Keywords
- Hydrocephalus, cerebral ventricles, cerebrospinal fluid, white matter fibers, functional biomarkers
- Medical subject headings
- Hydrocephalus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
During management, patients with hydrocephalus will be subjected to flow MRI and diffusion MRI. Flow parameters and diffusion parameters will be measured and compared to those found in control subjects receiving the same type of imaging
| Study group | Role | What they receive |
|---|---|---|
| Patients with hydrocephalus | Experimental | Age > 55, Ventricular dilation: Evans Index > 0.3; Patients with cognitive impairment, and gait disturbances and/or urinary incontinence or a combination of these three symptoms; Absence of other neurological diseases that could cause ventriculomegaly, information and non-opposition. Receives: Other: MRI |
| Controls | Active comparator | Age ≥ 55; No ventricular dilation: Evans Index < 0.3; Individuals who have no neurological or psychiatric disease; No neurological deficit. No history of neurosurgery or head trauma; signed informed consent; affiliation to a social security scheme. Receives: Other: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of MRI flow between both groups
Measured: 3 years
Variation of MRI diffusion between both groups
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start14 Dec 2019
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HydrocephalusStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05825521
- Sponsor's protocol ID
- PI2021_843_0117
- Acronym
- HYDRODIFF
- Status last verified
- Apr 2023
- First submitted
- 11 Apr 2023
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Cerebral Ventricular Dilatations and Cerebrospinal Fluid Pulsations on Periventricular White Matter in Hydrocephalic Patients
- ClinicalTrials.gov ID
- NCT05825521
- Acronym / sponsor ID
- HYDRODIFF / PI2021_843_0117
- Keywords
- Hydrocephalus, cerebral ventricles, cerebrospinal fluid, white matter fibers, functional biomarkers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 14 Dec 2019 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 24 Apr 2023 (actual)
- 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.
Hydrocephalus is characterized by excessive accumulation of cerebrospinal fluid (CSF) in the ventricles of the brain. One of the forms of hydrocephalus is called "normal pressure", although one of the main signs is precisely an alteration of the intracranial pressure (ICP), it is here called active hydrocephalus (HA). Although MRI is the reference radiological modality for the characterization of HA. The Evan's and DESH index are radiological diagnostic criteria based on the dilation and morphology of the CSF compartments. These morphological indices remain insensitive and specific. In recent years, advances in Phase Contrast (MRI-PC) and Diffusion (MRI-DTI) MRI have generated new biomarkers of brain viability. The aim of this study is to characterize by MRI the impact of hydrocephalus on brain fluids and tissues.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with hydrocephalus | Experimental | Other: MRIAge > 55, Ventricular dilation: Evans Index > 0.3; Patients with cognitive impairment, and gait disturbances and/or urinary incontinence or a combination of these three symptoms; Absence of other neurological diseases that could cause ventriculomegaly, information and non-opposition. |
| Controls | Active comparator | Other: MRIAge ≥ 55; No ventricular dilation: Evans Index < 0.3; Individuals who have no neurological or psychiatric disease; No neurological deficit. No history of neurosurgery or head trauma; signed informed consent; affiliation to a social security scheme. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- For Patients with hydrocephalus:
- Age > 55,
- Ventricular dilation: Evans Index > 0.3;
- Patients with cognitive impairment, and gait disturbances and/or urinary incontinence or a combination of these three symptoms;
- Absence of other neurological diseases that could cause ventriculomegaly, information and non-opposition.
Key exclusion criteria (6 listed)
- All patients who have a neurological disease other than active hydrocephalus will be excluded;
- Individuals unable to sign or understand consent;
- Individuals with psychiatric, neurological or medical development;
- Individuals under treatment with psychoactive drugs;
- Individuals who cannot tolerate an MRI examination;
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 |
|---|---|---|
| MRIDuring management, patients with hydrocephalus will be subjected to flow MRI and diffusion MRI. Flow parameters and diffusion parameters will be measured and compared to those found in control subjects receiving the same type of imaging | Other | Controls, Patients with hydrocephalus |
Primary outcome
Variation of MRI flow between both groups
Time frame: 3 years
Variation of MRI diffusion between both groups
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Hydrocephalus
RecruitingPhase 2
CEUS Evaluation of Hydrocephalus in Neonates and Infants
Hydrocephalus in Infants, Hydrocephalus Acquired
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
RecruitingObservational study
Natural History of Treated Neurocysticercosis and Long-Term Outcomes
Cysticercosis, Neurocysticercosis
RecruitingObservational study
Development of Non-Invasive Prenatal Diagnosis for Single Gene Disorders
Invasive PreNatal Diagnosis in a Context of Family History of Single-gene Disorders, Including, Sickle Cell Disease
Active, not recruiting
HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants
Hydrocephalus
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Hydrocephalus and Cerebral Ventricle, run by Centre Hospitalier Universitaire, Amiens at 1 site 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 13 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olivier BALEDENT, MD (33 3 22 08 95 20, olivier.baledent@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of MRI flow between both groups (time frame: 3 years). The study lists 2 primary outcomes in all. 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 27 Apr 2023.