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

This study has been terminated.
(Funding was withdrawn by Codman as expected number of patient subjects enrolled did not meet expected numbers.)
Sponsor:
Information provided by (Responsible Party):
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00613886
First received: January 3, 2008
Last updated: June 26, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Normal Pressure Hydrocephalus
Device: Programmable Shunt Insertion (Codman, Medtronic)
Behavioral: Assessments in physical therapy, occupational therapy, and speech therapy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Factors Predicting Response to Shunting in Normal Pressure Hydrocephalus

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • Evans Ratio [ Time Frame: initial and follow-up visits ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physical Therapy, Occupational Therapy, and Speech Therapy [ Time Frame: 30 min per clinic visit ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: March 2006
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Subjective comparisons made for patients - before and after external lumbar drain, before and after shunt surgery
Device: Programmable Shunt Insertion (Codman, Medtronic)
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.
Other Names:
  • Codman Shunt
  • Medtronic Strata Valve
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00613886

Locations
United States, California
University of California, Irvine - Medical Center
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: Laura Pare, MD, FRCSC UC Irvine
  More Information

No publications provided

Responsible Party: University of California, Irvine
ClinicalTrials.gov Identifier: NCT00613886     History of Changes
Other Study ID Numbers: HS 2005-4609, J&J Proposal #38973, Award #032906
Study First Received: January 3, 2008
Last Updated: June 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
NPH
Normal Pressure Hydrocephalus

Additional relevant MeSH terms:
Hydrocephalus
Hydrocephalus, Normal Pressure
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Intracranial Hypertension

ClinicalTrials.gov processed this record on September 16, 2014