The Role of the Glymphatic System Avaluated Thourgh Mr Imaging in the Diagnosis and Management of NPH
NCT ID: NCT06857136
Last Updated: 2025-03-04
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Total Enrollment
29 participants
Study Classification
OBSERVATIONAL
Study Start Date
2021-06-15
Study Completion Date
2024-12-31
Brief Summary
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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
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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Detailed Description
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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.
* 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.
Conditions
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Hydrocephalus
Normal Pressure Hydrocephalus
Study Design
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Observational Model Type
CASE_CONTROL
Study Time Perspective
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* clinical and radiological diagnosis of probable NPH according to existing guidelines
* age of over 50 years
* 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
* diagnosis of any other neurological pathology, particularly neurodegenerative or neuroinflammatory
* previous neurosurgical interventions on the brain of any type.
* inability to undergo general anaesthesia
Minimum Eligible Age
50 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Morgan A Broggi, MD
Role: PRINCIPAL_INVESTIGATOR
Fondazione IRCCS Istituto Neurologico Carlo Besta
Locations
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Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, , Italy
Site Status
Countries
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Italy
References
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Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GLINFANPH_2021
Identifier Type: -
Identifier Source: org_study_id
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