Hydrocephalus, Normal Pressure Hydrocephalus
Conditions
Keywords
hydrocephalus, Normal pressure hydrocephalus, NPH, Glymphatic System, DTI-ALPS, Diffusion Tensor Imaging, ALPS-index
Brief 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.
Interventions
None listed
Sponsors
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison between study and control group | 4 years | Difference in DTI ALPS index between NPH patients and healthy controls |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in response to tap test between NPH patients who responded and those who did not | 4 years | Difference in DTI ALPS index between NPH who responded to tap test (and underwent to ventircolopetoneal shunt) and those who did not |
| Change in DTI ALPS index across treatment in NPH patients | 4 years | Difference in DTI ALPS index in NPH patients between T0 (before TT), T1 (after TT) and T3 (after VP shunt) |
| Change in CSF degenerative biomarker concentrations | 4 years | CSF degenerative biomarkers (total tau protein, p-181 tau protein, Aβ42 e Aβ40 protein) variation between T1, T2 and T3 |
Countries
Italy
Contacts
PRINCIPAL_INVESTIGATORMorgan A Broggi, MD
Fondazione IRCCS Istituto Neurologico Carlo Besta
Outcome results
None listed