Multimodal Investigation in the Diagnosis and Treatment of Chronic Adult Hydrocephalus

Not Applicable

Completed

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

• Registration Number: NCT02278848
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-18
• Study Start: 2014-07-21
• Study First Submitted QC: 2014-10-27
• Study First Posted: 2014-10-30
• Primary Completion: 2018-07-21
• Study Completion: 2018-07-21
• Status Verified: 2023-01
• Last Update Submitted: 2023-11-30
• Last Update Posted: 2023-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnosis of ICAH	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

Primary Outcome Measures

Name	Time	Method
Urinary incontinence	5 days	Association between the decision-making with regard to permanent CSF shunt and the Urinary incontinence scale
Computerised gait analysis	5 days	Association between the decision-making with regard to permanent CSF shunt and the Computerised gait analysis,
Ultrasound measurement of cerebral pulsatility	5 days	Association between the decision-making with regard to permanent CSF shunt and the Ultrasound measurement of cerebral pulsatility,
Cerebrospinal fluid biomarkers of degeneration from Alzheimer's disease.	5 days	Association between the decision-making with regard to permanent CSF shunt and the response to subtractive lumbar puncture
Qualitative and quantitative analysis (average speed and flow) of the hydrodynamic characteristics of the cerebrospinal fluid.	5 days	Association between the decision-making with regard to permanent CSF shunt and the MRI flow,

Trial Locations

Locations (1)

CHRU de Tours; 🇫🇷 Tours, France