Multimodal Investigation in the Diagnosis and Treatment of Chronic Adult Hydrocephalus

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Brief Title

Multimodal Investigation in the Diagnosis and Treatment of Chronic Adult Hydrocephalus

Official Title

Multimodal Investigation in the Diagnosis and Treatment of Chronic Adult Hydrocephalus

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.
    



Study Type

Interventional


Primary Outcome

Cerebrospinal fluid biomarkers of degeneration from Alzheimer's disease.


Condition

Chronic Adult Hydrocephalus

Intervention

Diagnosis of ICAH using new investigative techniques (computerised gait analysis, ultrasound, MRI flow, urinary incontinence scale)

Study Arms / Comparison Groups

 Diagnosis of ICAH
Description:  One arm: patients with chronic adult hydrocephalus.
All patients have: Computerised gait analysis, Ultrasound measurement of cerebral pulsatility, MRI flow, Urinary incontinence scale

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

40

Start Date

July 2014

Completion Date

July 2016

Primary Completion Date

July 2016

Eligibility 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
      

Gender

All

Ages

65 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Karl MONDON, +33234378952, [email protected]

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT02278848

Organization ID

PHAO 2013- KM / Multimod'HCA


Responsible Party

Sponsor

Study Sponsor

University Hospital, Tours


Study Sponsor

Karl MONDON, Principal Investigator, CHRU de Tours


Verification Date

October 2014