The Role of the Glymphatic System Avaluated Thourgh mr Imaging in the Diagnosis and Management of NPH (GLINFANPH_2021)

February 9, 2026 updated by: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

The goal of this observational study is to evaluate the role of DTI-ALPS in the diagnostic and therapeutic management of NPH

The main questions it aims to answer are:

  • Whether the glymphatic system (GS) is actually impaired in NPH
  • Whether DTI-ALPS index can predict the positive response to tap test (TT) and to ventriculo-peritoneal shunt (VPS) surgery.

A healthy control group of patients (HC group) matched for age with the study group, will undergo MR with DTI-ALPS study

Study Overview

Status

Completed

Conditions

Detailed Description

Enrolled patients followed a diagnostic-therapeutic pathway, consisting of the following steps:

  • t0: MR with DTI-ALPS study;
  • t1 (within 7 days from T0): clinical and neurosurgical assessment with NPH-specific rating scales (detailed below) before and after a lumbar TT, including measurements of opening pressure, drainage of 40-50 mL of CSF and collection of samples for neurodegenerative biomarkers (β-Amyloid 40, 42 total and P-Tau) quantification. An MR with DTI-ALPS study within 6 hours from TT;
  • t2 (within 3 months from T1): patients with a positive TT response (included responders, IR group) underwent VPS surgery, with CSF samples collected for the same neurodegenerative biomarkers (β-Amyloid 40, 42 total and P-Tau);
  • t3 (three months after surgery, IR group only): clinical and neurosurgical evaluation using NPH-specific rating scales to classify patients as improved, unchanged, or worsened compared to their preoperative condition; MR with DTI-ALPS study.

Study Type

Observational

Enrollment (Actual)

29

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20133
        • Fondazione IRCCS Istituto Neurologico Carlo Besta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients affected by normal pressure hydrocephalus

Description

Suspected NPH patients according to the following:

Inclusion Criteria:

  • clinical and radiological diagnosis of probable NPH according to existing guidelines
  • age of over 50 years

Exclusion Criteria:

  • inability to undergo MR
  • diagnosis of any other neurological pathology, particularly neurodegenerative or neuroinflammatory
  • previous neurosurgical interventions on the brain of any type.
  • inability to undergo general anaesthesia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Study group
Patients attending the NPH outpatient clinic were prospectively enrolled in the study. The inclusion criteria were: (i) clinical and radiological diagnosis of probable NPH according to existing guidelines and (ii) age of over 50 years. Exclusion criteria were: (i) inability to undergo MR; (ii) a diagnosis of any other neurological pathology, particularly neurodegenerative or neuroinflammatory; (iii) previous neurosurgical interventions on the brain of any type; (iv) inability to undergo general anaesthesia.
Control group
A healthy control group of patients (HC group) matched for age with the IR group, underwent MR with DTI-ALPS study. Exclusion criteria for this group were: (i) a previous diagnosis of any neurological disorder of any type. (ii) a history of neurosurgical intervention of any kind; and (iii) a prior diagnosis of malignancy of any type.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison between study and control group
Time Frame: 4 years
Difference in DTI ALPS index between NPH patients and healthy controls
4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in response to tap test between NPH patients who responded and those who did not
Time Frame: 4 years
Difference in DTI ALPS index between NPH who responded to tap test (and underwent to ventircolopetoneal shunt) and those who did not
4 years
Change in DTI ALPS index across treatment in NPH patients
Time Frame: 4 years
Difference in DTI ALPS index in NPH patients between T0 (before TT), T1 (after TT) and T3 (after VP shunt)
4 years
Change in CSF degenerative biomarker concentrations
Time Frame: 4 years
CSF degenerative biomarkers (total tau protein, p-181 tau protein, Aβ42 e Aβ40 protein) variation between T1, T2 and T3
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Investigators

  • Principal Investigator: Morgan A Broggi, MD, Fondazione IRCCS Istituto Neurologico Carlo Besta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2021

Primary Completion (Actual)

August 31, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

February 26, 2025

First Submitted That Met QC Criteria

February 26, 2025

First Posted (Actual)

March 4, 2025

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GLINFANPH_2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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