NCT05562596

Brief Summary

Normal Pressure Hydrocephalus (NPH) is a clinical condition that induces cognitive deterioration that can be reverted, at least in part, by introducing ventricular-peritoneal diversion controlled by a miniaturized valve system. Mechanisms involved in such an improvement of cognitive function after liquor diversion are unknown. Oxysterols are a family of cholesterol-related compounds having diverse biological functions. Among others, they are involved in cholesterol homeostasis in the brain and are detectable in liquor, potentially impacting neurodegeneration. NPH is an ideal clinical model to study oxysterol distribution in liquor before and after ventricular-peritoneal diversion.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

June 21, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 3, 2022

Completed
27 days until next milestone

Study Start

First participant enrolled

October 30, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

October 3, 2022

Status Verified

September 1, 2022

Enrollment Period

1.4 years

First QC Date

June 21, 2022

Last Update Submit

September 29, 2022

Conditions

Normal Pressure HydrocephalusCognitive Impairment

Keywords

normal pressure hydrocephalusneurodegenerationcognitive impairmentoxysterolsmass spectrometry

Outcome Measures

Primary Outcomes (2)

  • Oxysterol levels in peripheral and central brain liquor

    Comparison between values of quantitative analysis of oxysterols in liquor collected at time of spinal and central liquor obtained at spinal tap and ventricular drainage

    2 months

  • Correlation between oxysterol levels in the peripheral and central liquor and MMSE score

    Evaluation of potential correlation between oxysterol levels and mini-mental status examination score.

    2 months

Interventions

Measurement of oxysterol profile, including 20 molecules, in liquor before and after surgeryDIAGNOSTIC_TEST

Samples are quantitated by deuterium-labeled mass-spectrometry amalysis.

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with a confirmed diagnosis of NPH based on clinical and a diagnostic tap-test

You may qualify if:

  • Patients with a diagnosis of NPH

You may not qualify if:

  • Patients with a non-performing ASA score to the intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Goretti Hospital

Latina, LT, 04100, Italy

Location

Related Publications (9)

  • Hakim S, Adams RD. The special clinical problem of symptomatic hydrocephalus with normal cerebrospinal fluid pressure. Observations on cerebrospinal fluid hydrodynamics. J Neurol Sci. 1965 Jul-Aug;2(4):307-27. doi: 10.1016/0022-510x(65)90016-x. No abstract available.

    PMID: 5889177BACKGROUND

  • Adams RD, Fisher CM, Hakim S, Ojemann RG, Sweet WH. SYMPTOMATIC OCCULT HYDROCEPHALUS WITH "NORMAL" CEREBROSPINAL-FLUID PRESSURE. A TREATABLE SYNDROME. N Engl J Med. 1965 Jul 15;273:117-26. doi: 10.1056/NEJM196507152730301. No abstract available.

    PMID: 14303656BACKGROUND

  • Williams MA, Relkin NR. Diagnosis and management of idiopathic normal-pressure hydrocephalus. Neurol Clin Pract. 2013 Oct;3(5):375-385. doi: 10.1212/CPJ.0b013e3182a78f6b.

    PMID: 24175154BACKGROUND

  • Hashimoto M, Ishikawa M, Mori E, Kuwana N; Study of INPH on neurological improvement (SINPHONI). Diagnosis of idiopathic normal pressure hydrocephalus is supported by MRI-based scheme: a prospective cohort study. Cerebrospinal Fluid Res. 2010 Oct 31;7:18. doi: 10.1186/1743-8454-7-18.

    PMID: 21040519BACKGROUND

  • Mori E, Ishikawa M, Kato T, Kazui H, Miyake H, Miyajima M, Nakajima M, Hashimoto M, Kuriyama N, Tokuda T, Ishii K, Kaijima M, Hirata Y, Saito M, Arai H; Japanese Society of Normal Pressure Hydrocephalus. Guidelines for management of idiopathic normal pressure hydrocephalus: second edition. Neurol Med Chir (Tokyo). 2012;52(11):775-809. doi: 10.2176/nmc.52.775.

    PMID: 23183074BACKGROUND

  • Forner Giner J, Sanz-Requena R, Florez N, Alberich-Bayarri A, Garcia-Marti G, Ponz A, Marti-Bonmati L. Quantitative phase-contrast MRI study of cerebrospinal fluid flow: a method for identifying patients with normal-pressure hydrocephalus. Neurologia. 2014 Mar;29(2):68-75. doi: 10.1016/j.nrl.2013.02.016. Epub 2013 May 3. English, Spanish.

    PMID: 23643684BACKGROUND

  • Iuliano L, Crick PJ, Zerbinati C, Tritapepe L, Abdel-Khalik J, Poirot M, Wang Y, Griffiths WJ. Cholesterol metabolites exported from human brain. Steroids. 2015 Jul;99(Pt B):189-93. doi: 10.1016/j.steroids.2015.01.026. Epub 2015 Feb 7.

    PMID: 25668615BACKGROUND

  • Crick PJ, William Bentley T, Abdel-Khalik J, Matthews I, Clayton PT, Morris AA, Bigger BW, Zerbinati C, Tritapepe L, Iuliano L, Wang Y, Griffiths WJ. Quantitative charge-tags for sterol and oxysterol analysis. Clin Chem. 2015 Feb;61(2):400-11. doi: 10.1373/clinchem.2014.231332. Epub 2014 Dec 15.

    PMID: 25512642BACKGROUND

  • Testa G, Staurenghi E, Zerbinati C, Gargiulo S, Iuliano L, Giaccone G, Fanto F, Poli G, Leonarduzzi G, Gamba P. Changes in brain oxysterols at different stages of Alzheimer's disease: Their involvement in neuroinflammation. Redox Biol. 2016 Dec;10:24-33. doi: 10.1016/j.redox.2016.09.001. Epub 2016 Sep 16.

    PMID: 27687218BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Liquor (1 mL) specimens are collected before (BF) and at the time of surgery (SG). Samples are snap frozen at -80 °C until analysis. In particular, sample BF is collected at the time of instrumental evaluation for diagnosis by liquor tap, and SG sample taken during surgery, which is made within one month of sample collection BF.

MeSH Terms

Conditions

Hydrocephalus, Normal PressureCognitive DysfunctionNerve Degeneration

Condition Hierarchy (Ancestors)

HydrocephalusBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCognition DisordersNeurocognitive DisordersMental DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Luigi Iuliano, M.D.

    University of Roma La Sapienza

    PRINCIPAL INVESTIGATOR

  • Gianpaolo Petrella, M.D.

    AUSL Latina

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Luigi Iuliano, M.D.

CONTACT

+393406462332luigi.iuliano@uniroma1.it

Gianpaolo Petrella, M.D.

CONTACT

+393476352149g.petrella@ausl.latina.it

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Internal Medicine

Study Record Dates

First Submitted

June 21, 2022

First Posted

October 3, 2022

Study Start

October 30, 2022

Primary Completion

April 1, 2024

Study Completion

July 1, 2024

Last Updated

October 3, 2022

Record last verified: 2022-09

Locations

IT(1)