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Multimodal Investigation in the Diagnosis and Treatment of Chronic Adult Hydrocephalus

NCT ID: NCT02278848

Last Updated: 2023-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-21

Study Completion Date

2018-07-21

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Adult Hydrocephalus

Keywords

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Computerised gait analysis Ultrasound measurement of cerebral pulsatility MRI flow Urinary incontinence scale Subtractive lumbar puncture

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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

Interventions

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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)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Tours

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karl MONDON

Role: PRINCIPAL_INVESTIGATOR

CHRU de Tours

Locations

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CHRU de Tours

Tours, , France

Site Status

Countries

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France

Other Identifiers

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PHAO 2013- KM / Multimod'HCA

Identifier Type: -

Identifier Source: org_study_id