Factors Predicting Response to Shunting in Normal Pressure Hydrocephalus - Full Text View

Sponsor:	University of California, Irvine
Information provided by:	University of California, Irvine
ClinicalTrials.gov Identifier:	NCT00613886

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:	Diagnostic, Open Label, Single Group Assignment
Official Title:	Factors Predicting Response to Shunting in Normal Pressure Hydrocephalus

Resource links provided by NLM:

MedlinePlus related topics: Hydrocephalus Speech and Communication Disorders

U.S. FDA Resources

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 ]

Estimated Enrollment:	130
Study Start Date:	March 2006
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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. 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)

Arms

Assigned Interventions

1: Experimental

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.

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

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

Contacts

Contact: Laura Pare, MD, FRCSC

714-456-6966 ext 2606

lpare@uci.edu

Locations

United States, California
University of California, Irvine - Medical Center	Recruiting
Orange, California, United States, 92868
Contact: Laura Pare, MD, FRCSC 714-456-6966 ext 2606 lpare@uci.edu

Sponsors and Collaborators

University of California, Irvine

Investigators

Principal Investigator:

Laura Pare, MD, FRCSC

UC, Irvine

More Information

Additional Information:

UC, Irvine Medical Center - Dept of Neurosurgery's NPH webpage This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University of California, Irvine ( Dr. Laura Pare, MD, FRCSC )
Study ID Numbers:	HS 2005-4609, J&J Proposal #38973, Award #032906
Study First Received:	January 3, 2008
Last Updated:	January 29, 2010
ClinicalTrials.gov Identifier:	NCT00613886 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Irvine:

NPH
Normal Pressure Hydrocephalus

Additional relevant MeSH terms:

Nervous System Diseases
Infant, Newborn, Diseases
Central Nervous System Diseases
Hydrocephalus, Normal Pressure

Hydrocephalus
Brain Diseases
Intracranial Hypertension

ClinicalTrials.gov processed this record on February 08, 2010