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(Funding was withdrawn by Codman as expected number of patient subjects enrolled did not meet expected numbers.)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

January 3, 2008
June 26, 2013
March 2006
April 2009   (final data collection date for primary outcome measure)
Evans Ratio [ Time Frame: initial and follow-up visits ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00613886 on ClinicalTrials.gov Archive Site
Physical Therapy, Occupational Therapy, and Speech Therapy [ Time Frame: 30 min per clinic visit ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Factors Predicting Response to Shunting in Normal Pressure Hydrocephalus
Factors Predicting Response to Shunting in Normal Pressure Hydrocephalus

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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Normal Pressure Hydrocephalus
  • 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)
Experimental: 1
Subjective comparisons made for patients - before and after external lumbar drain, before and after shunt surgery
Interventions:
  • Device: Programmable Shunt Insertion (Codman, Medtronic)
  • Behavioral: Assessments in physical therapy, occupational therapy, and speech therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
16
April 2009
April 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00613886
HS 2005-4609, J&J Proposal #38973, Award #032906
No
University of California, Irvine
University of California, Irvine
Not Provided
Principal Investigator: Laura Pare, MD, FRCSC UC Irvine
University of California, Irvine
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP