UnknownNot Applicable

Volumetrics and Proteomics in Shunted Normal Pressure Hydrocephalus

Sweden58 participantsStarted 2021-03-08

Plain-language summary

Idiopathic normal pressure hydrocephalus (=iNPH) is a condition with disturbed circulation of cerebrospinal fluid (=CSF) causing symptoms such as balance and gait disorders, urinary incontinence and cognitive impairment in patients with cerebral ventricular dilation. The exact incidence is unknown but has been estimated at about 8.9% of the population over the age of 80 and the incidence is estimated to increase with an aging population. The symptoms can be temporarily improved by draining cerebrospinal fluid and so-called shunting (surgery with diversion of cerebrospinal fluid from the brain to the abdominal cavity). The symptoms and pathophysiology of iNPH are poorly described as well as the protein distribution in cerebrospinal fluid (proteomics) of the disease. There is also a need for improved diagnostical and prognostical tools that can guide in patient selection for surgery. The radiological tools in evaluating the disease and it´s progression need to be improved. There is a shunt valve (Codman Certas Plus) used since 2015 that is widely used in clinical use and is well studied in research laboratories but little in clinical studies. The project aims to, before and after surgery, on patients with iNPH who will undergo investigation and shunting with Certas Plus at our department and in comparison with healthy controls: 1. Apply and evaluate a novel method to determine the volume of circulating CSF (volumetry). 2. Study the correlation between changes in volumetry and clinical outcome 3. Study NPH patients' distribution of proteins in cerebrospinal fluid and their change over time after shunting. 4. Evaluate the efficacy and functions of the Certas Plus valve. In this way, the investigators hope to find increased knowledge about the NPH disease and its pathophysiology as well as useful instruments that can both predict the probability for a patient to be improved by a shunt operation and determine if a shunt has stopped working and thus be able to avoid unnecessary risky operations.

Who can participate

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Idiopathic normal pressure hydrocephalus scale

Timeframe: Assessed within 3 months pre-operatively and 3 months post-operatively.

Change from baseline CSF volume at 2 days postoperatively.

Timeframe: Assessed on MRI scan 36-48 hours post-operatively.

Change from baseline CSF volume at 3 months post-operatively.

Timeframe: Assessed on MRI scan 3 months post-operatively

Change from Baseline iNPH Radscale at 2 Days post-operatively.

Timeframe: Assessed on MRI scan 36-48 hours post-operatively and 3. 3 months post-operatively

Change from Baseline iNPH Radscale at 3 months post-operatively.

Timeframe: Assessed on MRI scan 3 months post-operatively.

Number of participants with shunt complications

Timeframe: From the day of surgery until 3 months post-operatively.

Proteomic pattern of alpha-1B-glycoprotein in lumbar, ventricular CSF and blood plasma.

Trial details

NCT IDNCT04785560

SponsorUniversity Hospital, Linkoeping

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07

View on ClinicalTrials.gov More Hydrocephalus, Normal Pressure trials