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OpenTrials
Completed

NCT Number: NCT06857136

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

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

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, 20133, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Comparison between study and control group

    Time frame: 4 years

    Difference in DTI ALPS index between NPH patients and healthy controls

Secondary outcomes

  1. 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

  2. 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)

  3. 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

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Acronym: GLINFANPH_2021

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Mar 4, 2025
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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