Investigating Neurofilament Light in Hydrocephalus Patients
The Role of Neurofilament Light (NfL) in Management of Patients With Hydrocephalus: A Pilot Study
NA · University Hospital Hradec Kralove · NCT05399602
This study is testing if measuring a protein called Neurofilament Light can help doctors understand brain damage in people with hydrocephalus and improve their treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | University Hospital Hradec Kralove (other) |
| Locations | 1 site (Hradec Králové) |
| Trial ID | NCT05399602 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the role of Neurofilament Light Chain Protein (NfL) as a biomarker for neuronal damage in patients with hydrocephalus. By measuring NfL levels, the research seeks to understand how these levels change in response to treatment and how they can inform management strategies for hydrocephalus. The study involves various interventions, including lumbar punctures and general anesthesia, to assess the impact on NfL levels. The findings could lead to improved treatment protocols for patients suffering from this condition.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with communicating hydrocephalus who have a Mini-Mental State Examination (MMSE) score greater than 10 and no structural lesions on MRI or CT.
Not a fit: Patients with non-communicating hydrocephalus or those with significant structural lesions on imaging will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the management and treatment of hydrocephalus by utilizing NfL as a predictive biomarker.
How similar studies have performed: Previous studies have shown promise in using NfL as a biomarker for various neurodegenerative conditions, suggesting potential success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * In group A: * Patients with diagnosed communicating hydrocephalus * MMSE \> 10 points * Absence of any structural laesion on MRI or CT * Accepted Informed consent * In group B: * MMSE \> 10 points * Absence of any structural laesion on MRI or CT * Accepted Informed consent * Elective spinal surgery without affecting dural sac and the spinal cord * Surgery shorter than 120 minutes of lasting the general anesthesia Exclusion Criteria: * Non-communicating hydrocephalus * Structural laesion on MRI or CT (tumour, contusion, aneurysm) * MMSE \< 10 points * Life-expectancy shorter than 1 year * Pre-existing other type of demetia (m. Alzheimer, vascular dementia) * Surgery lasting more than 120 minutes * Blood loss more than 500 ml * Opening of dural sac (liquororhea) * Adverse events during general anestesia: MAP\<60 mm Hg more than 5 minutes, arythmia with need for farmacological treatment
Where this trial is running
Hradec Králové
- University Hospital Hradec Kralove — Hradec Králové, Czechia (RECRUITING)
Study contacts
- Principal investigator: Miroslav Cihlo, M.D. — University Hospital Hradec Kralove
- Study coordinator: Miroslav Cihlo, M.D.
- Email: miroslav.cihlo@fnhk.cz
- Phone: +420495832550
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: Hydrocephalus, Brain Damage, General Anesthetics Toxicity, Brain biomarkers, Neurofilament Light Chain, General Anesthesia