CLINICAL TRIAL

Treatment for Idiopathic Normal Pressure Hydrocephalus (INPH)

Recruiting · 18+ · All Sexes · Seattle, WA

This study is evaluating whether a shunt surgery is effective in people with idiopathic normal pressure hydrocephalus.

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About the trial for Idiopathic Normal Pressure Hydrocephalus (INPH)

Eligible Conditions
Idiopathic Normal Pressure Hydrocephalus (INPH) · Hydrocephalus, Normal Pressure · Hydrocephalus

Treatment Groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Control Group 1
programmable CSF shunt valve
DEVICE
Control Group 2
programmable CSF shunt valve
DEVICE

Eligibility

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
History or evidence of gait impairment (such as decreased step height or length, decreased speed, retropulsion as described in the iNPH Guidelines) duration ≥ 6 months;
Participant has the sensory motor skills, communication skills and understanding to comply with the testing and reporting required in the PENS trial;
Age ≥ 60 years;
Diagnosis of iNPH and recommendation for shunt surgery based on the Investigator's clinical judgement based on criteria and testing as described in the iNPH Guidelines;
Evans Ratio ≥ 0.30;
One positive supplementary test to include either large volume Lumbar Puncture or extended CSF drainage per institutional standards;
Participant is able to give written informed consent.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 9 months
Screening: ~3 weeks
Treatment: Varies
Reporting: 9 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 9 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Treatment will improve 3 secondary outcomes in patients with Idiopathic Normal Pressure Hydrocephalus (INPH). Measurement will happen over the course of Baseline and 9 months.

Change in Gait velocity
BASELINE AND 9 MONTHS
Evaluate the change in gait velocity among all study participants between baseline and 9 months of active shunting, using the primary outcome of gait velocity (in meters per second).
BASELINE AND 9 MONTHS
Bladder Control as assessed by the Overactive Bladder Questionnaire, short form
9 MONTHS
Evaluate the effect of shunting between active and placebo-controlled groups at nine months using Overactive Bladder Questionnaire, short form (OAB-q sf.) to assess bladder control. All scale scores are transformed to a 0- to 100-point scale, with lower scores indicating greater effect, i.e., worse QOL.
9 MONTHS
Cognition as assessed by the Montreal Cognitive Assessment (MoCA)
9 MONTHS
Evaluate the effect of shunting between active and placebo-controlled groups at nine months using MoCA test to assess cognition. Scores on the MoCA range from zero to 30, with a score of 26 and higher generally considered normal.
9 MONTHS

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is treatment?

Patients with inph generally have poor outcomes in terms of their functional independence and quality of life regardless of the surgical therapy used. Treatment based on the severity of symptoms, age, and patient preference is therefore important for treatment selection. Clinical trials evaluating new therapies may be able to address this need for further intervention in inph.

Anonymous Patient Answer

What are common treatments for idiopathic normal pressure hydrocephalus (inph)?

In terms of common treatments for INPH, it is important to pay attention to the type of treatment. The main treatment for INPH, shunting (ventriculoperitoneal or VP shunts), can be considered for INPH patients with normal cerebrospinal fluid pressure. In the absence of a definitive diagnosis, the main treatment for INPH is medical treatment, with various types of anticonvulsants, paroxetine, hydrocortisone and propranolol being commonly prescribed. In most cases, INPH is benign and therefore can be observed if a long term trial is considered.

Anonymous Patient Answer

What causes idiopathic normal pressure hydrocephalus (inph)?

There is a broad spectrum of diseases and injuries that can cause inph other than the most common one, intracranial hemorrhage. The cause of inph has been an important scientific puzzle for over 200 years. Recently, a number of plausible explanations for inph have been posited to explain the phenomenon, but unfortunately most are unsupported. The underlying mechanism of hydrocephalus pathophysiology is an important and evolving area for further investigation.

Anonymous Patient Answer

Can idiopathic normal pressure hydrocephalus (inph) be cured?

All patients exhibited an improvement, both in terms of their neurological status and in the amount of cerebral ventricle size. Patients with a normal pressure hydrocephalus after a successful shunting showed significant improvement in neurological status.

Anonymous Patient Answer

What are the signs of idiopathic normal pressure hydrocephalus (inph)?

The symptoms of inph and shunt complications are many and varied. They can be nonspecific, making the diagnosis challenging for both the clinician and patient. A careful history and physical examination can provide clues to the diagnosis of inph but cannot reliably identify its exact cause or the degree of brain dysfunction in each case. Shunted hydrocephalus is a particular form of pressure hydrocephalus. A shunt cerebrospinal fluid (CSF) analysis is a reliable indicator that the pressure in the ventricles is due to an obstruction.

Anonymous Patient Answer

What is idiopathic normal pressure hydrocephalus (inph)?

Idiopathic normal pressure hydrocephalus is a brain condition that typically begins between the ages of 30 and 40, and is marked by slow, steady buildup of fluid in the brain cavity. The exact cause of idiopathic normal pressure hydrocephalus is unknown, but one hypothesis is that it is related to blockage of the ventricular outflow for cerebrospinal fluid (CSF). Normal pressure hydrocephalus (inph) is a condition in which CSF accumulates inside the brain cavity. Patients typically experience headaches, nausea, and vomiting as they undergo the buildup. Although they normally do not have seizures, some patients have seizures.

Anonymous Patient Answer

How many people get idiopathic normal pressure hydrocephalus (inph) a year in the United States?

About 50 people per year get inph in the Unites States. This is about 10 times more frequent than the age-matched background rate of inph in the general U.S.-dwelling population.

Anonymous Patient Answer

What are the latest developments in treatment for therapeutic use?

A variety of new treatments for INPH, including shunt revisions, neuroendoscopic and transsphenoidal surgery, and novel approaches to drug treatment and new gene or gene-therapy approaches are ongoing. The use of MRI in treating INPH patients has progressed tremendously; we can now classify INPH into an early stage of the disease or a late stage of the disease, on the basis of the degree of ventricular dilatation and the presence or absence of shunt malfunction.

Anonymous Patient Answer

What is the latest research for idiopathic normal pressure hydrocephalus (inph)?

There is very little new information about INPH, although evidence for increased cerebral blood flow and increased levels of vasospasm as well as new findings for INPH in children have been reported. The role of blood pressure alterations in INPH is unclear but merits further investigation. Although the association between cerebral blood flow and the severity of INPH as well as the presence of intracerebroventricular shunts in INPH have been found. There is little evidence of any influence of the blood-pressure alterations on outcomes. Furthermore, INPH has been observed to occur in people with normal blood pressure and can be triggered following a small head trauma.

Anonymous Patient Answer

Does treatment improve quality of life for those with idiopathic normal pressure hydrocephalus (inph)?

[Inph] treatment is associated with improved physical vitality scores but not with improvements in psychological vitality. Inpatient treatments should be offered as a viable form of treatment so that patients can make well-explored treatment decisions.

Anonymous Patient Answer

How does treatment work?

A positive effect in INPH patients was observed with the administration of intravenous methylprednisolone, after which a sustained reduction was obtained. It seems that methylprednisolone would produce a better clinical picture and a better outcome in INPH patients.

Anonymous Patient Answer

Does idiopathic normal pressure hydrocephalus (inph) run in families?

Findings from a recent study support the hypothesis that inph is an inherited disorder. Findings from a recent study warrant larger studies to define the prevalence and penetrance of inph in families at risk.

Anonymous Patient Answer
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