Normal Pressure HydrocephalusPROLIPHYCNCT02016352
Cerebrospinal Fluid Proteome in Hydrocephalus
A study testing patient CSF extraction with hydrocephalus and witness CSF extraction in people with Normal Pressure Hydrocephalus, run by University Hospital, Toulouse at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Normal Pressure Hydrocephalus
- What is being tested?
- patient CSF extraction with hydrocephalus and witness CSF extraction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Gait problems, cognitive decline, urinary incontinence and enlarged ventricles on imaging
Who cannot join
- Psychiatric disorders
- Lumbar punction contraindication
- RMI contraindication
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Normal Pressure Hydrocephalus
- Being tested
- patient CSF extraction with hydrocephalus, witness CSF extraction
- Keywords
- hydrocephalus, proteomic, cerebrospinal fluid
- Medical subject headings
- Hydrocephalus, Normal Pressure, Hydrocephalus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient CSF extraction with hydrocephalusBiological
CSF extraction
witness CSF extractionBiological
CSF extraction from patient not suffering from hydrocephalus
| Study group | Role | What they receive |
|---|---|---|
| patient | Experimental | patient CSF extraction with hydrocephalus Receives: Biological: patient CSF extraction with hydrocephalus |
| witness | Other | patient without hydrocephalus but with peridural catheter for anesthetic. Witness CSF extraction has realized on catheter. Receives: Biological: witness CSF extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
CSF proteome measure
CSF extraction (3 ml)
Measured: 48 hours
Secondary outcomes (2)
correlation between CSF proteome and gait analysis
compare results from CSF proteome and gait analysis
Measured: 72 hours
correlation between CSF proteome and MRI brain imaging
compare results from CSF proteome and brain imaging
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2013 (estimated)
- Study startMar 2013
- Primary completionSep 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Normal Pressure HydrocephalusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric SCHMIDT, MD PhD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02016352
- Sponsor's protocol ID
- 10 045 08
- Other IDs
- 2011-A01091-40
- Acronym
- PROLIPHYC
- Status last verified
- Nov 2020
- First submitted
- 18 Jun 2013
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35325129Vallet 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.
PubMed 31997040Guillotin 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.
PubMed 38698559
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebrospinal Fluid Proteome in Hydrocephalus
- ClinicalTrials.gov ID
- NCT02016352
- Acronym / sponsor ID
- PROLIPHYC / 10 045 08
- Conditions
- Normal Pressure Hydrocephalus
- Keywords
- hydrocephalus, proteomic, cerebrospinal fluid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 20 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient | Experimental | Biological: patient CSF extraction with hydrocephaluspatient CSF extraction with hydrocephalus |
| witness | Other | Biological: witness CSF extractionpatient without hydrocephalus but with peridural catheter for anesthetic. Witness CSF extraction has realized on catheter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Gait problems, cognitive decline, urinary incontinence and enlarged ventricles on imaging
Key exclusion criteria (3 listed)
- Psychiatric disorders
- Lumbar punction contraindication
- RMI contraindication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patient CSF extraction with hydrocephalusCSF extraction | Biological | patient |
| witness CSF extractionCSF extraction from patient not suffering from hydrocephalus | Biological | witness |
Primary outcome
CSF proteome measure
Time frame: 48 hours
CSF extraction (3 ml)
2 secondary outcomes
correlation between CSF proteome and gait analysis
Time frame: 72 hours
correlation between CSF proteome and MRI brain imaging
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Results publication: PubMed 35325129Guillotin 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.
- Results publication: PubMed 31997040Vallet 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.
- Results publication: PubMed 38698559Guillotin 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric SCHMIDT, MD PhD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing patient CSF extraction with hydrocephalus and witness CSF extraction in people with Normal Pressure Hydrocephalus, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CSF proteome measure (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02016352, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.