Role of Brain Specific Biomarkers in Hydrocephalus

CompletedOBSERVATIONAL
Enrollment

32

Participants

Timeline

Start Date

November 1, 2023

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2024

Conditions
Hydrocephalus, Normal PressureBiochemical Lesions Head RegionBrain Damage
Interventions
DIAGNOSTIC_TEST

Lumbar puncture

Standardized lumbar puncture in L3/4 or L4/5 in diagnosis of hydrocephalus and cerebrospinal fluid sampling (sample 1 in measurement)

DIAGNOSTIC_TEST

External lumbar drainage

External lumbar drainage placement for assessing responsivity of external derivation of cerebrospinal fluid. It is test of responsivity to ventriculo-peritoneal shunt placement

PROCEDURE

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).

PROCEDURE

Prechamber puncture

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)

PROCEDURE

Blood sampling #1

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

PROCEDURE

Blood sampling #2

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

PROCEDURE

Blood sampling #3

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

PROCEDURE

Blood sampling #4 and #5

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)

Trial Locations (1)

50005

University Hospital Hradec Kralove, Hradec Králové

All Listed Sponsors
lead

University Hospital Hradec Kralove

OTHER

NCT06083233 - Role of Brain Specific Biomarkers in Hydrocephalus | Biotech Hunter | Biotech Hunter