NCT06857136

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 29 (actual)
• Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Hydrocephalus
• Normal Pressure Hydrocephalus

Timeline

• Start date: 2021-06-15
• Primary completion: 2024-08-31
• Completion: 2024-12-31
• First posted: 2025-03-04
• Last updated: 2026-02-11

Locations

1 site across 1 country: Italy