NCT02016352

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2013

Completed
6 months until next milestone

First Posted

Study publicly available on registry

December 20, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 15, 2025

Status Verified

November 1, 2020

Enrollment Period

2.5 years

First QC Date

June 18, 2013

Last Update Submit

December 5, 2025

Conditions

Keywords

hydrocephalusproteomiccerebrospinal fluid

Outcome Measures

Primary Outcomes (1)

  • CSF proteome measure

    CSF extraction (3 ml)

    48 hours

Secondary Outcomes (2)

  • correlation between CSF proteome and gait analysis

    72 hours

  • correlation between CSF proteome and MRI brain imaging

    72 hours

Study Arms (2)

patient

EXPERIMENTAL

patient CSF extraction with hydrocephalus

Biological: patient CSF extraction with hydrocephalus

witness

OTHER

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

Biological: witness CSF extraction

Interventions

CSF extraction from patient not suffering from hydrocephalus

witness

CSF extraction

patient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Psychiatric disorders
  • Lumbar punction contraindication
  • RMI contraindication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital

Toulouse, 31059, France

Location

Related Publications (3)

  • Guillotin S, Vallet A, Lorthois S, Cestac P, Schmidt E, Delcourt N. Association Between Homocysteine, Frailty and Biomechanical Response of the CNS in NPH-Suspected Patients. J Gerontol A Biol Sci Med Sci. 2022 Jul 5;77(7):1335-1343. doi: 10.1093/gerona/glac074.

  • Vallet A, Del Campo N, Hoogendijk EO, Lokossou A, Baledent O, Czosnyka Z, Balardy L, Payoux P, Swider P, Lorthois S, Schmidt E. Biomechanical response of the CNS is associated with frailty in NPH-suspected patients. J Neurol. 2020 May;267(5):1389-1400. doi: 10.1007/s00415-019-09689-z. Epub 2020 Jan 29.

  • Guillotin S, Fulzele A, Vallet A, de Peredo AG, Mouton-Barbosa E, Cestac P, Andrieu S, Burlet-Schiltz O, Delcourt N, Schmidt E. Cerebrospinal fluid proteomic profile of frailty: Results from the PROLIPHYC cohort. Aging Cell. 2024 Jul;23(7):e14168. doi: 10.1111/acel.14168. Epub 2024 May 2.

MeSH Terms

Conditions

Hydrocephalus, Normal PressureHydrocephalus

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Eric SCHMIDT, MD PhD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2013

First Posted

December 20, 2013

Study Start

March 1, 2013

Primary Completion

September 1, 2015

Study Completion

December 1, 2015

Last Updated

December 15, 2025

Record last verified: 2020-11

Locations