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Factors Predicting Response to Shunting in Normal Pressure Hydrocephalus (NPH)

Primary Purpose

Normal Pressure Hydrocephalus

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Programmable Shunt Insertion (Codman, Medtronic)
Assessments in physical therapy, occupational therapy, and speech therapy
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Normal Pressure Hydrocephalus focused on measuring NPH, Normal Pressure Hydrocephalus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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
  • MMSE (Mini-mental status exam): < or = 10
  • Urinary incontinence

Exclusion Criteria:

  • 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

Sites / Locations

  • University of California, Irvine - Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Comparison for patients of lumbar drain and shunt surgery

Arm Description

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)

Outcomes

Primary Outcome Measures

Evans Ratio
A brain CT scan is obtained after the first week to ten days and the shunt is adjusted according to the patients signs and symptoms. Prior to any downward adjustment of the shunt valve (which allows more CSF drainage), a brain CT is obtained to look for subdural hematoma or effusion. If any type of subdural collection is found, the valve pressure is increased (to reduce CSF flow) until the collection resolves.

Secondary Outcome Measures

Physical Therapy, Occupational Therapy, and Speech Therapy
The evaluations for physical therapy, occupational therapy and speech therapy are performed along with external lumbar drainage (ELD) to assess NPH subjects.

Full Information

First Posted
January 3, 2008
Last Updated
December 18, 2020
Sponsor
University of California, Irvine
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1. Study Identification

Unique Protocol Identification Number
NCT00613886
Brief Title
Factors Predicting Response to Shunting in Normal Pressure Hydrocephalus
Acronym
NPH
Official Title
Factors Predicting Response to Shunting in Normal Pressure Hydrocephalus
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Terminated
Why Stopped
Funding was withdrawn as number of subjects enrolled did not meet expectation
Study Start Date
March 2006 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Irvine

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The research project is designed to determine which combination of tests will enable physicians to predict whether a patient with symptoms of normal pressure hydrocephalus (NPH) will improve with a shunt.
Detailed Description
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: to confirm the ability of external lumbar drainage to increase the success rate of selectively shunting patients with NPH compared to historical controls 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Normal Pressure Hydrocephalus
Keywords
NPH, Normal Pressure Hydrocephalus

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Comparison for patients of lumbar drain and shunt surgery
Arm Type
Experimental
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
Programmable Shunt Insertion (Codman, Medtronic)
Other Intervention Name(s)
Codman Shunt, Medtronic Strata Valve
Intervention Description
Medical Device - Shunt insertion surgery of adjustable valve and laparoscopic assistance for placement of peritoneal catheter. Patient will be brought to operating room suite where general anesthesia is induced. Patient will be placed with a small roll on shoulder, supine, on the operating room table. Patient's head will be turned with the parietal area uppermost in the field. Patient will be prepared and draped in the usual sterile fashion. Site prep includes parietooccipital area, side of neck, chest, and entire abdomen. Ventricular catheter placed and then attached to shunt valve. Catheter is then fitted over grooved blue burr hole guide. Excess catheter pulled down to pull valve into pocket on the skull. Sterile dressings applied.
Intervention Type
Behavioral
Intervention Name(s)
Assessments in physical therapy, occupational therapy, and speech therapy
Intervention Description
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)
Primary Outcome Measure Information:
Title
Evans Ratio
Description
A brain CT scan is obtained after the first week to ten days and the shunt is adjusted according to the patients signs and symptoms. Prior to any downward adjustment of the shunt valve (which allows more CSF drainage), a brain CT is obtained to look for subdural hematoma or effusion. If any type of subdural collection is found, the valve pressure is increased (to reduce CSF flow) until the collection resolves.
Time Frame
initial and follow-up visits
Secondary Outcome Measure Information:
Title
Physical Therapy, Occupational Therapy, and Speech Therapy
Description
The evaluations for physical therapy, occupational therapy and speech therapy are performed along with external lumbar drainage (ELD) to assess NPH subjects.
Time Frame
30 min per clinic visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 MMSE (Mini-mental status exam): < or = 10 Urinary incontinence Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Pare, MD, FRCSC
Organizational Affiliation
UC Irvine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Irvine - Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States

12. IPD Sharing Statement

Links:
URL
http://neurosurgery.uci.edu/nph_article.shtml
Description
UC, Irvine Medical Center - Dept of Neurosurgery's NPH webpage

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Factors Predicting Response to Shunting in Normal Pressure Hydrocephalus

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