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Multimodal Investigation in the Diagnosis and Treatment of Chronic Adult Hydrocephalus (Multimod'HCA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02278848
Recruitment Status : Unknown
Verified October 2014 by University Hospital, Tours.
Recruitment status was:  Recruiting
First Posted : October 30, 2014
Last Update Posted : October 30, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital, Tours

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Chronic Adult Hydrocephalus Other: Diagnosis of ICAH using new investigative techniques (computerised gait analysis, ultrasound, MRI flow, urinary incontinence scale) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Multimodal Investigation in the Diagnosis and Treatment of Chronic Adult Hydrocephalus
Study Start Date : July 2014
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Diagnosis of ICAH

One arm: patients with chronic adult hydrocephalus.

All patients have: Computerised gait analysis, Ultrasound measurement of cerebral pulsatility, MRI flow, Urinary incontinence scale

Other: 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)




Primary Outcome Measures :
  1. 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

  2. Computerised gait analysis [ Time Frame: 5 days ]
    Association between the decision-making with regard to permanent CSF shunt and the Computerised gait analysis,

  3. 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,

  4. 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,

  5. Urinary incontinence [ Time Frame: 5 days ]
    Association between the decision-making with regard to permanent CSF shunt and the Urinary incontinence scale



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Contraindications to MRI
  • Inability to walk or to stand before having lumbar puncture
  • Patient under trusteeship and guardianship, or judicial protection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02278848


Contacts
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Contact: Karl MONDON +33234378952 karl.mondon@med.univ-tours.fr
Contact: Emilie BEAUFILS +33247479787 E.BEAUFILS@chu-tours.fr

Locations
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France
CHRU de Tours Recruiting
Tours, France, 37044
Sub-Investigator: Emilie BEAUFILS         
Sub-Investigator: Caroline HOMMET         
Sub-Investigator: Jean-Philippe COTTIER         
Sub-Investigator: Illyes ZEMMOURA         
Sub-Investigator: Mounir BEN ISMAIL         
Sub-Investigator: Eric LIORET         
Sub-Investigator: Christophe DESTRIEUX         
Sub-Investigator: Frederic PATAT         
Sponsors and Collaborators
University Hospital, Tours
Investigators
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Principal Investigator: Karl MONDON CHRU de Tours

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Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT02278848    
Other Study ID Numbers: PHAO 2013- KM / Multimod'HCA
First Posted: October 30, 2014    Key Record Dates
Last Update Posted: October 30, 2014
Last Verified: October 2014
Keywords provided by University Hospital, Tours:
Computerised gait analysis
Ultrasound measurement of cerebral pulsatility
MRI flow
Urinary incontinence scale
Subtractive lumbar puncture
Additional relevant MeSH terms:
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Hydrocephalus
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases