CSF Protein Markers as Prognostic Indicators of the Response to CSF Shunt in Normotensive Hydrocephalus

Condition(s) studied

Investigational drug(s) / intervention(s)

Lumbar CSF protein marker determination: The cerebrospinal fluid levels of the Aβ1-42 amyloid, h-tau and phospho-tau proteins will be assessed. The response of patients to the possible implantation of a ventricular peritoneal shunt will be assessed through neuropsychological, gait and ventricular size studies assessed through cerebral magnetic resonance studies.

Study summary

In all published series of adult chronic hydrocephalus, there is a percentage between twenty and twenty-five percent of patients who present poor results after implantation of a cerebrospinal fluid shunt,1-11 usually ventriculoperitoneal. The lumboperitoneal shunt is also used but much more rarely.

The diagnosis of this pathology is based on the clinical picture, neuroimaging studies (Evans index and corpus callosum angle), cerebrospinal fluid dynamics tests (Katzman test), and invasive intracranial pressure measurements. Despite all this diagnostic arsenal, there is a high percentage of patients (mentioned above) in which treatment by diversion of cerebrospinal fluid does not offer the expected results. Traditionally, this has been attributed to chronic adult hydrocephalus being associated with other types of dementia. This may be the case in some patients, and it would be important to predict which patients will not improve or who will improve poorly in the case of insertion of a cerebrospinal fluid shunt.

Eligibility

Primary outcome measure(s)

• Correlation Between CSF Amyloid β1-42 Level and Shunt Response — 1 year
  Correlation between lumbar CSF Amyloid β1-42 concentration and clinical outcome following CSF shunting. Unit of Measure: pg/mL
• Correlation Between CSF Total Tau (h-tau) Level and Shunt Response — 1 year
  Correlation between lumbar CSF total tau concentration and clinical outcome following CSF shunting. Unit of Measure: pg/mL
• Correlation Between CSF Phospho-Tau Level and Shunt Response — 1 year
  Correlation between lumbar CSF phospho-tau concentration and clinical outcome following CSF shunting. Unit of Measure: pg/mL
• Threshold Levels of CSF Biomarkers Associated With Poor Shunt Response — 1 year
  Identification of cutoff values of CSF β1-42 amyloid, total tau, and phospho-tau associated with poor clinical response after CSF shunting. Unit of Measure: pg/mL

Trial sites (2)

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