Clinical Trials Logo

Clinical Trial Summary

To investigate if progression from prodromal into symptomatic NPH can be predicted from advanced neuroimaging, biomarkers in cerebrospinal fluid (CSF) and plasma and investigate the unknown mechanisms causing deterioration by investigating longitudinal changes in the above-mentioned variables. Three different cohorts with both asymptomatic and symptomatic patients as well as healthy controls will be investigated over time, both without intervention and before and after shunt surgery.


Clinical Trial Description

Three prospective cohorts will be included during five years from seven European centers. Group 1 - Prodromal NPH. Patients with imaging features associated with iNPH and no symptoms, or to little symptoms to motivate shunt surgery, will be included prospectively. At baseline, an MRI of the brain will be performed and a lumbar puncture to collect CSF as well as blood samples. The patients will be followed with a standardized scheme that will go on for as long as the patient chose to remain in the study or until the patient develops symptoms and are referred for shunt surgery. The study scheme includes repeated assessments of symptoms, MRI of the brain, CSF samples and blood samples. The following study visits are planned before surgery: baseline, 6 months, 1st year, 2nd year, 4th year, 6th year. After shunt surgery, clinical evaluations and blood samples will be collected at four assessments during five years post-operative. Group 2 - Healthy controls - For every patient in Group 1, one patient can be included in Group 2. They will be investigated with the same protocol as Group 1 but only follow the protocol for one cycle (Baseline to year 4). Group 3 - Symptomatic NPH - For each included individual in Group 1 (prodromal NPH), two patients are included in Group 3 (symptomatic NPH). These patients are consecutively included at each centre from routine patients that are planned for shunt surgery. They should be age matched with the individual in Group 1 (+/- 3 years). Their investigations will be identical with the post-operative routine for five years as Group 1. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05910944
Study type Observational
Source Uppsala University Hospital
Contact Johan Virhammar, MD, PhD
Phone +46186110000
Email johan.virhammar@neuro.uu.se
Status Recruiting
Phase
Start date November 1, 2023
Completion date December 31, 2035

See also
  Status Clinical Trial Phase
Recruiting NCT06040697 - Formative Usability Assessment of Wireless Thermal Anisotropy Devices
Terminated NCT02408757 - Sonographic Monitoring of Weaning of Cerebrospinal Fluid Drainages
Terminated NCT01863381 - Comparison of Continuous Non-Invasive and Invasive Intracranial Pressure Measurement N/A
Completed NCT00652470 - A Study Comparing Two Treatments for Infants With Hydrocephalus Phase 2
Completed NCT00196196 - A Precision and Accuracy Study of the Codman Valve Position Verification (VPV) System. Phase 3
Terminated NCT05501002 - Pilot Study to Evaluate the CereVasc® eShunt® System in the Treatment of Communicating Hydrocephalus N/A
Active, not recruiting NCT05068128 - Combined Flow and Pressure Study of Craniospinal Dynamic
Completed NCT04496414 - Bactiseal Catheter Safety Registry in China
Terminated NCT02900222 - Study of Choroid Plexus Cauterization in Patients With Hydrocephalus N/A
Recruiting NCT04099823 - MR Evaluation of Cerebrospinal Fluid (CSF) Dynamics N/A
Unknown status NCT02775136 - An Evaluation of a Non-invasive Brain Monitor N/A
Completed NCT00692744 - Quality of Life in Elderly After Aneurysmal Subarachnoid Hemorrhage (SAH) N/A
Recruiting NCT04758611 - The ETCHES I Study (Endovascular Treatment of Communicating Hydrocephalus With an Endovascular Shunt) N/A
Completed NCT03595033 - Hydrocephalus iPad-App Based Intervention Study N/A
Completed NCT04207229 - CERTAS Programmable Valve Registry
Completed NCT01976559 - Comparison of Continuous Noninvasive and Invasive Intracranial Pressure Measurement--Celda Infusion Subprotocol N/A
Terminated NCT01973764 - Intraventricular Drain Insertion: Comparison of Ultrasound-guided and Landmark-based Puncture of the Ventricular System N/A
Completed NCT02381977 - Prevalence of Acute Critical Neurological Disease in Children: a Global Epidemiological Assessment N/A
Recruiting NCT06086561 - Longitudinal Measurements of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device N/A
Recruiting NCT03650101 - Improving Infant Hydrocephalus Outcomes in Uganda