Role of Brain Specific Biomarkers in Hydrocephalus
1 other identifier
observational
32
1 country
1
Brief Summary
Normal pressure hydrocephalus (NPH) is a neurodegenerative disease of unclear etiology characterized by a clinical trias named after the neurosurgeon Hakim. It includes cognitive impairment (dementia), gait disturbance, and urinary incontinence. These symptoms, which frequently occur in the elderly population, often overlap with the symptoms of "other" neurodegenerative diseases, especially Alzheimer's disease and other (pre)senile dementias. To distinguishing NPH from "other" dementias is crucial in determining whether a patient will benefit from a surgical procedure (ventriculoperitoneal shunt placement) or not. At the same time, the options for assessing the patient's condition's progression and distinguishing between the progression of neurodegeneration in a broader sense or malfunction of the drainage system are very limited. Therefore, the role of a biomarker that could meet these expectations mentioned above is highly desirable.
Trial Health
Trial Health Score
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participants targeted
Target at P25-P50 for all trials
Started Nov 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 8, 2023
CompletedFirst Posted
Study publicly available on registry
October 13, 2023
CompletedStudy Start
First participant enrolled
November 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedFebruary 21, 2025
February 1, 2025
1.2 years
October 8, 2023
February 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comparison of levels of the mentioned biomarkers
Comparison of levels of the mentioned biomarkers between patients with clinically proven shunt-responsive and shunt-nonresponsive hydrocephalus
6 month
Secondary Outcomes (1)
Comparison of levels of the biomarkers during follow-up
6 month
Study Arms (2)
Study group "Responders"
Patients with diagnosed hydrocephalus undergoing surgery (VP shunt placement) in general anesthesia. Before surgery patients undergo lumbar puncture or external lumbar drainage placement to confirmed the diagnosis and responsivity to VP shunt placement.
Study group "Non-responders"
Patients with diagnosed hydrocephalus. VP shunt non-responsivity confirmed.
Interventions
Standardized lumbar puncture in L3/4 or L4/5 in diagnosis of hydrocephalus and cerebrospinal fluid sampling (sample 1 in measurement)
External lumbar drainage placement for assessing responsivity of external derivation of cerebrospinal fluid. It is test of responsivity to ventriculo-peritoneal shunt placement
Surgical procedure based on implantation a thin catheter into brain lateral ventricle (placed through a burrhole from Kocher point) and connection to prechamber and valve (placed behind the ear under skin) and similar thin catheter pushed under skin of neck, chest and abdomen (where put intraperitoneally).
Puncture of prechamber (place behind the ear under the skin) by thin needle and aspiration of 5 mL of cerebrospinal fluid (5 days, 1 month a 2 months after surgery)
Blood sampling to get level of biomarkers (NfL, NfH, NSE, S100, Tau, beta-amyloid) from standardized percutaneous vein puncture by thin needle 24 hours prior surgery
Blood sampling to get level of biomarkers (NfL, NfH, NSE, S100, Tau, beta-amyloid) from standardized percutaneous vein puncture by thin needle 24 hours after surgery
Blood sampling to get level of biomarkers (NfL, NfH, NSE, S100, Tau, beta-amyloid) from standardized percutaneous vein puncture by thin needle 5 days after surgery
Blood sampling to get level of biomarkers (NfL, NfH, NSE, S100, Tau, beta-amyloid) from standardized percutaneous vein puncture by thin needle 1 and 2 months after surgery (only in interventional group)
Eligibility Criteria
Patients with suspection on normal pressure hydrocephalus based on neurological examination
You may qualify if:
- Patients with diagnosed communicating hydrocephalus
- mini-mental state examination test \> 10 points
- Absence of any structural lesion on MRI or CT
- Accepted Informed consent
You may not qualify if:
- Non-communicating hydrocephalus
- Structural lesion on MRI or CT (tumour, contusion, aneurysm)
- mini-mental state examination test \< 10 points
- Life-expectancy shorter than 1 year
- Pre-existing other type of dementia (m. Alzheimer, vascular dementia)
- Surgery lasting more than 120 minutes
- Blood loss more than 500 ml
- Adverse events during general anesthesia: mean arterial pressure \< 60 mm Hg more than 5 minutes, arrythmia with need for pharmacological treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Hradec Kralove
Hradec Králové, 50005, Czechia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Miroslav Cihlo, M.D.
University Hospital Hradec Kralove
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
October 8, 2023
First Posted
October 13, 2023
Study Start
November 1, 2023
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
February 21, 2025
Record last verified: 2025-02