Using CSF protein markers to predict outcomes of shunt surgery in hydrocephalus patients
Alterations of CSF Protein Markers as Prognostic Indicator of the Response to Cerebrospinal Fluid Shunting in Chronic Hydrocephalus in Adults
University of Valencia · NCT05915000
This study is testing if certain protein markers in spinal fluid can help predict how well shunt surgery will work for adults with chronic hydrocephalus.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Valencia (other) |
| Locations | 2 sites (Valencia, Valencia and 1 other locations) |
| Trial ID | NCT05915000 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the prognostic value of cerebrospinal fluid (CSF) protein markers, specifically beta-amiloid and phospho-tau proteins, in predicting the response to CSF shunt surgery in patients with chronic hydrocephalus. The study will involve assessing ventricular size and cognitive and motor impairments before and after the shunt procedure. By analyzing these protein markers, researchers hope to identify which patients are likely to benefit from the surgery and which may not experience significant improvement. The study will include patients diagnosed with adult chronic hydrocephalus based on clinical and neuroimaging criteria.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with chronic adult hydrocephalus.
Not a fit: Patients with conditions such as cerebrovascular disease, Alzheimer's disease, or other forms of dementia unrelated to chronic hydrocephalus may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help tailor treatment plans for hydrocephalus patients, improving surgical outcomes and quality of life.
How similar studies have performed: While the approach of using CSF protein markers is promising, it remains relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Minimum age of 18 years, there is no maximum age, especially if it is understood that this pathology is more frequent as one advance in age, especially among males; pathology compatible with chronic adult hydrocephalus Exclusion Criteria: * All patients whose suspected diagnosis is not adult chronic hydrocephalus will be excluded, specifically those with cerebrovascular disease, dementia not due to adult chronic hydrocephalus, Alzheimer's disease, Parkinson's disease, and hereditary degenerative brain pathology. Huntington's chorea
Where this trial is running
Valencia, Valencia and 1 other locations
- Hospital General Universitario de Valencia — Valencia, Valencia, Spain (RECRUITING)
- Vicente Vanaclocha — Valencia, Valencia, Spain (RECRUITING)
Study contacts
- Study coordinator: Vicente Vanaclocha, Full Professor
- Email: vicente.vanaclocha@uv.es
- Phone: +34 963 13 18 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Beta-amiloid and Phospho-tau Proteins in CSF, Ventricular Size After CSF Shunt, Cognitive Impairment and CSF Shunt, Motor Impairment Evolution After CSF Shunt, Hydrocephalus, Normal pressure hydrocephalus, CSF shunt, Cognitive impairment