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NPHFactors Predicting Response to Shunting in Normal Pressure Hydrocephalus

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What is being tested

Programmable Shunt Insertion (Codman, Medtronic)

+ Assessments in physical therapy, occupational therapy, and speech therapy

DeviceBehavioral
Who is being recruted

Brain Diseases+2

+ Central Nervous System Diseases

+ Hydrocephalus

Over 18 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Interventional
Study Start: March 2006
See protocol details

Summary

Principal SponsorUniversity of California, Irvine
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2006

Actual date on which the first participant was enrolled.

Normal pressure hydrocephalus (NPH) is a potentially reversible progressive neurological condition disproportionately affecting the elderly population. Given current controversies regarding its exact definition, accurate incidence and prevalence figures are elusive. NPH was first described forty years ago as a triad of symptoms consisting of gait difficulties, urinary incontinence, and memory problems in patients with enlarged ventricles in the absence of increased intracranial pressure (ICP). The cause of primary, or idiopathic NPH (INPH) remains elusive, while secondary NPH results from intracranial insults such as head trauma, meningitis, or intracranial hemorrhage. NPH can be successfully treated with cerebrospinal fluid (CSF) shunting. However, the accurate diagnosis and treatment of patients with NPH remains problematic, despite significant advances in brain imaging and ICP physiology. Objectives - The primary aims of this study are: 1. to confirm the ability of external lumbar drainage to increase the success rate of selectively shunting patients with NPH compared to historical controls 2. to refine the diagnosis of NPH by determining whether the factors that change before and after lumbar drainage will predict failure to improve after shunting. A related aim is to assess the complications attributable to lumbar drainage. 3. to perform a preliminary evaluation of programmable shunt valves for NPH compared to historical controls using fixed-pressure valves. A related aim is to determine whether post-op objective analysis of gait, cognitive function and urinary symptoms will help refine the programmable shunt setting on an individual basis. Secondary study aims include: Investigating the pathophysiology of NPH by: 1) correlating cortical vein compliance measured by MRI flow quantification studies with CSF pressure waveform analysis; 2)assessing funduscopic changes before and during ELD; 3) performing and cross correlating CSF chemical analysis on screening positive and negative patients as well as screening-positive patients who are shunt responsive versus unresponsive.

Official TitleFactors Predicting Response to Shunting in Normal Pressure Hydrocephalus
NCT00613886
Principal SponsorUniversity of California, Irvine
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

24 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesCentral Nervous System DiseasesHydrocephalusHydrocephalus, Normal PressureNervous System Diseases

Criteria

6 inclusion criteria required to participate
Walking difficulties in both legs which has developed gradually, not explained by other conditions, either in combination with mental impairment and urinary incontinence

Brain CT or MRI findings of enlarged ventricles compared to established standards (minimum Evans ratio of 0.30 as measured by reviewing films)

Mental impairment must be mild to moderate, emerging with or after the walking difficulties

Age > or = 18 years old

Show More Criteria

4 exclusion criteria prevent from participating
No or only minimal walking difficulties combined with severe dementia

Severe medical problems with limited life expectancy (less than six months)

Contraindications to surgery

Lack of informed consent

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Subjective comparisons made for patients - before and after external lumbar drain, before and after shunt surgery. Device: Programmable Shunt Insertion (Codman Medtronic) Behavioral: Assessments in physical therapy, occupational therapy, and speech therapy Follow-up testing to be administered by trained physician assistant in the outpatient setting on an approximately monthly basis: 10m walk, timed up-and-go, mini-mental status exam, 9-hole grooved pegboard, motor visual perception test (MVPT), modified rankin score (MRS)

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University of California, Irvine - Medical Center

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SuspendedOne Study Center