Volumetrics and Proteomics in Shunted Normal Pressure Hydrocephalus (LiNPH)
Hydrocephalus, Normal Pressure, Ventriculomegaly, Cerebral, Shunt; Complications
About this trial
This is an interventional treatment trial for Hydrocephalus, Normal Pressure focused on measuring Hydrocephalus, Normal Pressure, Ventriculomegaly, Cerebral, Shunt; Complications, Hydrocephalus Acquired, Volumetry, Proteomics, Cerebrospinal Fluid, Ventriculoperitoneal shunt, Synthetic MRI
Eligibility Criteria
FOR iNPH-PATIENTS:
INCLUSION CRITERIA:
- Must meet the clinical criteria for iNPH according to the International Guide lines of 2005
- Must undergo shunt implantation at the Dpt of Neurosurgery Linköping University Hospital.
EXCLUSION CRITERIA:
- Individuals not able to participate/cooperate in study tasks with regard to cognitive symptoms
- Individuals with claustrophobia that makes awake MRI examination impossible.
- Individuals with implants that make MRI examination impossible (for instance pacemaker, refers only to the MRI examinations included in the study).
- Patients with severe co-existing chronical neurological diseases (refers only to the proteomic examinations included in the study).
FOR CONTROL GROUP VOLUNTEERS:
INCLUSION CRITERIA:
- Must undergo surgery under spinal anesthesia at the Dpt of Orthopaedics, Urology or Gynaecology at the University Hospital Linkoping.
- Must consider themselves neurologically healthy and have not undergone neurological disease.
EXCLUSION CRITERIA:
- Individuals with claustrophobia that makes awake MRI examination impossible.
- Individuals with implants that make MRI examination impossible
- Individuals with malignant disease or oncological treatment for such disease.
- Individuals with neurological disorders detected after study MRI.
Sites / Locations
- Neurosurgical department University Hospital Linköping
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Shunt setting 4 (=110 mm H20)
Shunt setting 8 (=400 mm H20)
Patients randomised to have the Certas Plus valve initial shunt setting post-operatively set to 4 (110 mm H20), our standard setting.
Patients randomised to have the Certas Plus valve initial shunt setting post-operatively set to 8 (400 mm H20 a k a virtual off), in practice a closed non-functional shunt.