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

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 Overview

• Status: Completed
• Conditions: Chronic Adult Hydrocephalus
• Intervention / Treatment: Other: Diagnosis of ICAH using new investigative techniques (computerised gait analysis, ultrasound, MRI flow, urinary incontinence scale)

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karl MONDON; Phone Number: +33234378952; Email: karl.mondon@med.univ-tours.fr
• Study Contact Backup: Name: Emilie BEAUFILS; Phone Number: +33247479787; Email: E.BEAUFILS@chu-tours.fr

Study Locations

• France
  • Tours, France, 37044
    • CHRU de Tours

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 63 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	5 days
Computerised gait analysis	Association between the decision-making with regard to permanent CSF shunt and the Computerised gait analysis,	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,	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,	5 days
Urinary incontinence	Association between the decision-making with regard to permanent CSF shunt and the Urinary incontinence scale	5 days

Collaborators and Investigators

• Sponsor: University Hospital, Tours
• Investigators: Principal Investigator: Karl MONDON, CHRU de Tours

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2014
• Primary Completion (Actual): July 21, 2018
• Study Completion (Actual): July 21, 2018

Study Registration Dates

• First Submitted: July 18, 2014
• First Submitted That Met QC Criteria: October 27, 2014
• First Posted (Estimated): October 30, 2014

Study Record Updates

• Last Update Posted (Estimated): December 7, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Computerised gait analysis; Ultrasound measurement of cerebral pulsatility; MRI flow; Urinary incontinence scale; Subtractive lumbar puncture
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hydrocephalus
• Other Study ID Numbers: PHAO 2013- KM / Multimod'HCA