The Usage of Telemetric Prechamber Sensor Reservoir in Management of Normal Pressure Hydrocephalus. Comparisson of Benefit for Patients with Implanted Telemetric Prechamber Sensor Reservoir.

CompletedOBSERVATIONAL
Enrollment

33

Participants

Timeline

Start Date

January 1, 2018

Primary Completion Date

October 31, 2024

Study Completion Date

December 31, 2024

Conditions
HydrocephalusNormal Pressure HydrocephalusNormal Pressure Hydrocephalus Patients
Interventions
DIAGNOSTIC_TEST

lumbar puncture

Standardized lumbar puncture in L3/4 or L4/5 in diagnosis of hydrocephalus and 10-meter-walking test prior and 4 hours after lumbar puncture. Mini-mental state examination is done.

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). Telemetric prechamber placement according the randomization (www.randomization.com) and the envelope method of choosing of patients.

DIAGNOSTIC_TEST

Follow-up control #1

Patients after VP shunt placement are assesed in gait, general condition and mini-mental state examination score 3 month after surgery. Brain CT control.

DIAGNOSTIC_TEST

Follow-up control #2

Patients after VP shunt placement are assesed in gait, general condition and mini-mental state examination score 6 month after surgery. Brain CT control.

DIAGNOSTIC_TEST

Follow-up control #3

Patients after VP shunt placement are assesed in gait, general condition and mini-mental state examination score 9 months after surgery. Brain CT control.

DIAGNOSTIC_TEST

Follow-up control #4

Patients after VP shunt placement are assesed in gait, general condition and mini-mental state examination score a month after surgery. Brain CT control, 10-meter-walking test, MMSE, self-assessment.

DIAGNOSTIC_TEST

Telemetric prechamber reading

Non-invasive reading of telemetric prechamber made during each follow-up control.

OTHER

Valve setting change

Changing of valve setting according patient's actual condition. Decission based on clinical state, radiological finding on CT and values readed from telemetric prechamber. Timing - each follow-up control.

Trial Locations (1)

50005

University Hospital Hradec Kralove, Hradec Králové

All Listed Sponsors
lead

University Hospital Hradec Kralove

OTHER

NCT06629168 - The Usage of Telemetric Prechamber Sensor Reservoir in Management of Normal Pressure Hydrocephalus. Comparisson of Benefit for Patients with Implanted Telemetric Prechamber Sensor Reservoir. | Biotech Hunter | Biotech Hunter