6857136
Last Update Posted: 2025-03-04
Recruiting has ended
All Genders accepted | 50 Years + |
29 Estimated Participants | No Expanded Access |
Observational Study | Accepts healthy volunteers |
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
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.
Eligibility
Relevant conditions:
Hydrocephalus
Normal Pressure Hydrocephalus
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the trial if you think are close to fitting criteria.
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Data sourced from ClinicalTrials.gov