Cerebrospinal Fluid Proteome in Hydrocephalus (PROLIPHYC)

Toulouse University Hospital

Status: Completed

Conditions: Normal Pressure Hydrocephalus

Treatments: Biological: witness CSF extraction; Biological: patient CSF extraction with hydrocephalus

Study type: Interventional

Funder types: Other

Identifiers

NCT02016352

10 045 08

2011-A01091-40 (Other Identifier)

Details and patient eligibility

About

PROLIPHYC is a collaborative prospective study that aims at discovering deep cerebrospinal fluid (CSF) proteome with a new clinically-compatible proteomics strategy, in a cohort of 100 patients suspected of neurodegenerative diseases and/or normal pressure hydrocephalus.

Full description

CSF proteome is the real time protein content that may reveal useful biomarkers for diagnosis and therapeutic decision-making. But the low protein concentration in CSF and the low volumes typically obtained after lumbar puncture precludes the conventional use of proteomic analysis. We miniaturized the method to be compatible with low-volume samples by combination of nanoLC-MS/MS analysis and combinatorial peptide ligand library technology to reduce the dynamic range of protein concentration in CSF and unmask previously undetected proteins. We demonstrated that this deep proteomic analysis allows profiling the CSF proteome with a reasonable depth, in short analytical times and good accuracy. We settled a clinically-compatible proteomics strategy targeting the deep CSF proteome discovery.

The PROLIPHYC study is a prospective study that aims at analysing CSF proteome with our new strategy in a cohort of patients suspected of normal pressure hydrocephalus and/or related neurodegenerative diseases. The PROLIPHYC project combines detailed clinical and neuropsychological evaluation, gait analysis, MRI brain imaging, lumbar CSF dynamics and deep proteome. We hypothesize in the PROLIPHYC study that a specific cluster of polypeptides can be associated with Alzheimer disease, vascular dementia and normal pressure hydrocephalus profiles. Validating this hypothesis might be a significant step towards a proteomic lexicon of aging brain, neurodegenerative diseases and dementia.

Neurosciences department and Alzheimer disease centre from the Toulouse University Hospital are both involved in this project. The deep proteomic study is performed in Toulouse by the Institute of Pharmacology and Structural Biology with the academic support of the Institute of Mathematics of Toulouse.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Gait problems, cognitive decline, urinary incontinence and enlarged ventricles on imaging

Exclusion criteria

• Psychiatric disorders
• Lumbar punction contraindication
• RMI contraindication

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

patient

Experimental group

Description:

patient CSF extraction with hydrocephalus

Treatment:

Biological: patient CSF extraction with hydrocephalus

witness

Other group

Description:

patient without hydrocephalus but with peridural catheter for anesthetic. Witness CSF extraction has realized on catheter.

Treatment:

Biological: witness CSF extraction