Chronic Adult HydrocephalusMultimod'HCANCT02278848
Multimodal Investigation in the Diagnosis and Treatment of Chronic Adult Hydrocephalus
A study testing Diagnosis of ICAH using new investigative techniques (computerised gait analysis, ultrasound, MRI flow, urinary incontinence scale) in people with Chronic Adult Hydrocephalus, run by University Hospital, Tours at 1 site in France.
Trial summary
Idiopathic chronic adult hydrocephalus (ICAH) is due to expansion of the fluid-filled cavities in the brain. The clinical symptoms are gait disturbance, mental decline and incontinence. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Chronic Adult Hydrocephalus
- What is being tested?
- Diagnosis of ICAH using new investigative techniques (computerised gait analysis, ultrasound, MRI flow, urinary incontinence scale)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jul 2014to 21 Jul 2018
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Adult 65 years or older
- Hospitalized patients (at the University Hospital of Tours) requiring the assessment of chronic hydrocephalus in adults, suspected clinically
- Patient undergoing Lumbar Puncture subtractive
- Informed consent form signed
- Affiliated to a medical insurance
Who cannot join
- Contraindications to MRI
- Inability to walk or to stand before having lumbar puncture
- Patient under trusteeship and guardianship, or judicial protection
Trial locations and contacts
1 site in 1 country.
About this study
Idiopathic chronic adult hydrocephalus (ICAH) is due to expansion of the fluid-filled cavities in the brain. The clinical symptoms are gait disturbance, mental decline and incontinence. Treatment involves installing a ventriculoperitoneal shunt which is known to be able to induce regression of the symptoms in many cases meaning that ICAH is a classic, curable cause of dementia. Diagnosis relies on comparing symptoms before and after depleting cerebrospinal fluid (CSF) via a lumbar puncture (LP). In practice, the situation is complicated: improvement is often incomplete and there is no consensus on either how to assess the symptoms or how they change after CSF depletion. In consequence, the decision whether not to undertake surgery often depends on the neurosurgeon's clinical impression.
Over recent years, the cognitive profile of patients with ICAH has become better characterised and reproducible, objective techniques have been developed to assess motor function and CSF flow in the brain.
The investigators project aims to define the value of these new investigative techniques in the positive diagnosis of ICAH, in comparison to current decision-making tools.
- Conditions
- Chronic Adult Hydrocephalus
- Being tested
- Diagnosis of ICAH using new investigative techniques (computerised gait analysis, ultrasound, MRI flow, urinary incontinence scale)
- Keywords
- Computerised gait analysis, Ultrasound measurement of cerebral pulsatility, MRI flow, Urinary incontinence scale, Subtractive lumbar puncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnosis of ICAH using new investigative techniques (computerised gait analysis, ultrasound, MRI flow, urinary incontinence scale)Other
Diagnosis of ICAH using new investigative techniques (computerised gait analysis, ultrasound, MRI flow, urinary incontinence scale)
| Study group | Role | What they receive |
|---|---|---|
| Diagnosis of ICAH | Experimental | One arm: patients with chronic adult hydrocephalus.
All patients have: Computerised gait analysis, Ultrasound measurement of cerebral pulsatility, MRI flow, Urinary incontinence scale Receives: Other: Diagnosis of ICAH using new investigative techniques (computerised gait analysis, ultrasound, MRI flow, urinary incontinence scale) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebrospinal fluid biomarkers of degeneration from Alzheimer's disease.
Association between the decision-making with regard to permanent CSF shunt and the response to subtractive lumbar puncture
Measured: 5 days
Computerised gait analysis
Association between the decision-making with regard to permanent CSF shunt and the Computerised gait analysis,
Measured: 5 days
Ultrasound measurement of cerebral pulsatility
Association between the decision-making with regard to permanent CSF shunt and the Ultrasound measurement of cerebral pulsatility,
Measured: 5 days
Qualitative and quantitative analysis (average speed and flow) of the hydrodynamic characteristics of the cerebrospinal fluid.
Association between the decision-making with regard to permanent CSF shunt and the MRI flow,
Measured: 5 days
Urinary incontinence
Association between the decision-making with regard to permanent CSF shunt and the Urinary incontinence scale
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2014 (estimated)
- Study start21 Jul 2014
- Primary completion21 Jul 2018
- Study completion21 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Adult HydrocephalusStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karl MONDON, Principal investigator, CHRU de Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02278848
- Sponsor's protocol ID
- PHAO 2013- KM / Multimod'HCA
- Acronym
- Multimod'HCA
- Status last verified
- Jan 2023
- First submitted
- 18 Jul 2014
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Investigation in the Diagnosis and Treatment of Chronic Adult Hydrocephalus
- ClinicalTrials.gov ID
- NCT02278848
- Acronym / sponsor ID
- Multimod'HCA / PHAO 2013- KM / Multimod'HCA
- Conditions
- Chronic Adult Hydrocephalus
- Keywords
- Computerised gait analysis, Ultrasound measurement of cerebral pulsatility, MRI flow, Urinary incontinence scale, Subtractive lumbar puncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 21 Jul 2014 (actual)
- Primary completion
- 21 Jul 2018 (actual)
- Study completion
- 21 Jul 2018 (actual)
- First posted
- 30 Oct 2014 (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.
Idiopathic chronic adult hydrocephalus (ICAH) is due to expansion of the fluid-filled cavities in the brain. The clinical symptoms are gait disturbance, mental decline and incontinence. Treatment involves installing a ventriculoperitoneal shunt which is known to be able to induce regression of the symptoms in many cases meaning that ICAH is a classic, curable cause of dementia. Diagnosis relies on comparing symptoms before and after depleting cerebrospinal fluid (CSF) via a lumbar puncture (LP). In practice, the situation is complicated: improvement is often incomplete and there is no consensus on either how to assess the symptoms or how they change after CSF depletion. In consequence, the decision whether not to undertake surgery often depends on the neurosurgeon's clinical impression.
Over recent years, the cognitive profile of patients with ICAH has become better characterised and reproducible, objective techniques have been developed to assess motor function and CSF flow in the brain.
The investigators project aims to define the value of these new investigative techniques in the positive diagnosis of ICAH, in comparison to current decision-making tools.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnosis of ICAH | Experimental | Other: Diagnosis of ICAH using new investigative techniques (computerised gait analysis, ultrasound, MRI flow, urinary incontinence scale)One arm: patients with chronic adult hydrocephalus. All patients have: Computerised gait analysis, Ultrasound measurement of cerebral pulsatility, MRI flow, Urinary incontinence scale |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Adult 65 years or older
- Hospitalized patients (at the University Hospital of Tours) requiring the assessment of chronic hydrocephalus in adults, suspected clinically
- Patient undergoing Lumbar Puncture subtractive
- Informed consent form signed
- Affiliated to a medical insurance
Key exclusion criteria (3 listed)
- Contraindications to MRI
- Inability to walk or to stand before having lumbar puncture
- Patient under trusteeship and guardianship, or judicial protection
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 |
|---|---|---|
| Diagnosis of ICAH using new investigative techniques (computerised gait analysis, ultrasound, MRI flow, urinary incontinence scale)Diagnosis of ICAH using new investigative techniques (computerised gait analysis, ultrasound, MRI flow, urinary incontinence scale) | Other | Diagnosis of ICAH |
Primary outcome
Cerebrospinal fluid biomarkers of degeneration from Alzheimer's disease.
Time frame: 5 days
Association between the decision-making with regard to permanent CSF shunt and the response to subtractive lumbar puncture
Computerised gait analysis
Time frame: 5 days
Association between the decision-making with regard to permanent CSF shunt and the Computerised gait analysis,
Ultrasound measurement of cerebral pulsatility
Time frame: 5 days
Association between the decision-making with regard to permanent CSF shunt and the Ultrasound measurement of cerebral pulsatility,
Qualitative and quantitative analysis (average speed and flow) of the hydrodynamic characteristics of the cerebrospinal fluid.
Time frame: 5 days
Association between the decision-making with regard to permanent CSF shunt and the MRI flow,
Urinary incontinence
Time frame: 5 days
Association between the decision-making with regard to permanent CSF shunt and the Urinary incontinence scale
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 7 Dec 2023.
Related trials for Chronic Adult Hydrocephalus
RecruitingObservational study
CSF Protein Markers as Prognostic Indicators of the Response to CSF Shunt in Normotensive Hydrocephalus
Beta-amiloid and Phospho-tau Proteins in CSF, Ventricular Size After CSF Shunt
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.
Karl MONDON principal investigator
CHRU de Tours
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnosis of ICAH using new investigative techniques (computerised gait analysis, ultrasound, MRI flow, urinary incontinence scale) in people with Chronic Adult Hydrocephalus, run by University Hospital, Tours 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 5 inclusion and 3 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 7 Dec 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?
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?
Cerebrospinal fluid biomarkers of degeneration from Alzheimer's disease. (time frame: 5 days). The study lists 5 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 7 Dec 2023.