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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00613886
Recruitment Status : Terminated (Funding was withdrawn by Codman as expected number of patient subjects enrolled did not meet expected numbers.)
First Posted : February 13, 2008
Last Update Posted : June 27, 2013
Information provided by (Responsible Party):
University of California, Irvine

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.

Condition or disease Intervention/treatment Phase
Normal Pressure Hydrocephalus Device: Programmable Shunt Insertion (Codman, Medtronic) Behavioral: Assessments in physical therapy, occupational therapy, and speech therapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Factors Predicting Response to Shunting in Normal Pressure Hydrocephalus
Study Start Date : March 2006
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hydrocephalus

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. Evans Ratio [ Time Frame: initial and follow-up visits ]

Secondary Outcome Measures :
  1. Physical Therapy, Occupational Therapy, and Speech Therapy [ Time Frame: 30 min per clinic visit ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00613886

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

Additional Information:
Responsible Party: University of California, Irvine Identifier: NCT00613886     History of Changes
Other Study ID Numbers: HS 2005-4609
J&J Proposal #38973 ( Other Identifier: J&J Proposal #38973 )
Award #032906 ( Other Identifier: Award #032906 )
First Posted: February 13, 2008    Key Record Dates
Last Update Posted: June 27, 2013
Last Verified: June 2013

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

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