Cerebrospinal Fluid Proteome in Hydrocephalus

Normal Pressure Hydrocephalus Clinical Trial

— PROLIPHYC  

Official title:

Cerebrospinal Fluid Proteome in Hydrocephalus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02016352
• Other study ID #: 10 045 08
• Secondary ID: 2011-A01091-40
• Status: Completed
• Phase: N/A
• Start date: March 2013
• Est. completion date: December 2015

Study information

• Verified date: November 2020
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Psychiatric disorders

• Lumbar punction contraindication

• RMI contraindication

Related Conditions & MeSH terms

• Hydrocephalus
• Hydrocephalus, Normal Pressure
• Normal Pressure Hydrocephalus

Intervention

Biological:
• patient CSF extraction with hydrocephalus
CSF extraction
• witness CSF extraction
CSF extraction from patient not suffering from hydrocephalus

Locations

Country	Name	City	State
France	Hospital	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (1)

Bech-Azeddine R, Høgh P, Juhler M, Gjerris F, Waldemar G. Idiopathic normal-pressure hydrocephalus: clinical comorbidity correlated with cerebral biopsy findings and outcome of cerebrospinal fluid shunting. J Neurol Neurosurg Psychiatry. 2007 Feb;78(2):157-61. Epub 2006 Sep 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CSF proteome measure	CSF extraction (3 ml)	48 hours
Secondary	correlation between CSF proteome and gait analysis	compare results from CSF proteome and gait analysis	72 hours
Secondary	correlation between CSF proteome and MRI brain imaging	compare results from CSF proteome and brain imaging	72 hours