Information for patients
Why we do this study?
Patients with normal-pressure hydrocephalus
(a form of hydrocephalus) have too much cerebrospinal fluid in the skull, which can lead to symptoms such as gait disturbances, memory problems and incontinence. The cause is unknown. There are two established surgical methods for treatment: the VP shunt, in which a tube drains cerebrospinal fluid into the abdomen, and the EDV, in which a small procedure creates an additional natural drainage pathway in the brain. In this study,
we are investigating whether the EDV leads to a similar rate of improvement in symptoms and quality of life for patients as the VP shunt. We also aim to investigate whether EDV has fewer side effects and complications than the VP shunt.
What happens in the study?
Your participation in this study will last 12 months. We will schedule a total of seven study visits, four of which will take place whilst you are in hospital. All these appointments are part of your standard treatment and would take place regardless of your participation in the study. Each appointment lasts approximately 15 to 90 minutes.
If you decide to take part, you will be randomly assigned to one of two groups. You will either be in the experimental group (EDV) or the control group (VP shunt). As this involves surgery, you will know which group you are in. In the experimental group, you will receive an EDV, and in the control group, you will be treated with a VP shunt.
Who can participate?
Inclusion criteria (Simplification of criteria for “probable” presence of an NPH according to the
iNPH guidelines16)
• Informed consent
• >40 years of age
• MUST show gait/balance disturbance,
PLUS cognition impairment AND/OR urinary dysfunction.
• Ventricular enlargement (Evans Index > 0.3)
not attributable to cerebral atrophy or congenital enlargement
Spinal Tap-Test
• Clinical improvement in at least one of the main symptoms after 20-40ml withdrawal of CSF
Risks
Participation in this study does not involve any increased risk, as it involves two surgical treatment methods that have been used very frequently in neurosurgery for many years. We have extensive surgical experience with both procedures. Nevertheless, surgical procedures carry a risk of complications. Many complications and side effects associated with these procedures can be managed medically. Should new information regarding risks and side effects emerge during the study, you will be informed immediately.
Risks and opportunities
A large part of the risks in this study can be attributed to the underlying disease of brain bleeding. Brain bleedings are serious illnesses that often lead to persisting disability or even death.
Nevertheless, there are rare risks associated with the operation, such as secondary bleeding or wound infections in the area of the surgical site. The study team or your treating neurosurgeon can advise you on further, specific risks.
In this study we minimize the risk as much as possible by giving all patients the current standard treatment. Furthermore, you could (but do not have to) benefit from the operation, which could lead to less disability in everyday life.
In summary, the greatest risks in this study is the underlying disease (brain bleeding), which can lead to permanent disability.
Risks and opportunities
