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ShuntCheck Use While Programming Shunts in Normal Pressure Hydrocephalus (NPH) Patients
This study is currently recruiting participants.
Verified by Neuro Diagnostic Devices, November 2008
Sponsors and Collaborators: Neuro Diagnostic Devices
Johns Hopkins University
Information provided by: Neuro Diagnostic Devices
ClinicalTrials.gov Identifier: NCT00793416
  Purpose

The purpose of the study is to examine the role of ShuntCheck, a non-invasive diagnostic device, in evaluating the presence or absence of flow or changes in flow rates in the presence of a potential shunt obstruction in patients with Normal Pressure Hydrocephalus. This is an exploratory study to determine how a non-invasive device can assist in detection of presence of flow in these patients.


Condition Intervention Phase
Normal Pressure Hydrocephalus
Device: Valve Adjustment (ShuntCheck)
Phase IV

MedlinePlus related topics: Hydrocephalus
U.S. FDA Resources
Study Type: Interventional
Study Design: Diagnostic, Open Label, Uncontrolled, Single Group Assignment
Official Title: Accuracy of ShuntCheck in Detection of Shunt Obstruction in Patients Receiving Adjustment of Programmable Shunt Valves

Further study details as provided by Neuro Diagnostic Devices:

Primary Outcome Measures:
  • Exploratory Evaluation of the Utility of ShuntCheck in detection of ShuntFlow in patients admitted with potential shunt obstruction [ Time Frame: Pre and post valve adjustment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess any adverse events that arise from conducting ShuntCheck test To asess the cost effectiveness of ShuntCheck screening upon completion of the study [ Time Frame: Pre and post Valve Adjustment and 4 weeks post adjustment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: November 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
ShuntCheck measure: Experimental
All patients will have ShuntCheck measurements along with valve adjustment
Device: Valve Adjustment (ShuntCheck)
Adjustment of the indwelling valve in shunted NPH patients

Detailed Description:

Patients will be enrolled if they present with symptoms of shunt obstruction and will need to have an adjustment to their valve to determine if flow can be restored or increased if found to be low. The study will be conducted in a clinic or a doctor's office or in an emergency room by the treating physician or by the trained health care professionals. ShuntCheck is an approved, non-invasive device which can be used as an aid to the detection of shunt flow. All patients who receive the standard of care procedure, namely, valve adjustment for suspected malfunction, will be enrolled in this study initially, in case symptoms are due to inadequate drainage by a patent shunt. These patients will be tested using ShuntCheck prior to and after adjustment of the valve to determine the presence of flow prior to and after adjustment. If needed, patients may be asked to return to the clinic after 4 weeks and assessed for clinical changes post valve adjustment. An absence of flow on ShuntCheck after adjustment and diagnosis of shunt obstruction upon follow-up visit will define the suspicion of obstruction that will necessiate further shunt patency studies. Approximately 40 patients will be enrolled.

  Eligibility

Ages Eligible for Study:   35 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult Patients > 35 years capable and willing to consent for their participation or consent obtained from a legal guardian.
  2. Patients with an indwelling shunt and clinical assessment strongly suggestive of shunt obstruction
  3. Patients are candidates for shunt patency procedures in the elective extension

Exclusion Criteria:

  1. Patients <35 years of age
  2. Patients with symptoms attributable to valve malfunction or shunt infection
  3. Patients who need urgent shunt replacement and therefore cannot wait for the SHUNTCHECK evaluation of shunt patency.
  4. Patients with edema or wound of skin overlying the shunt tissue.
  5. Patients not capable or not willing to consent to participate in the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00793416

Locations
United States, Maryland
Johns Hopkins Medical Center Recruiting
Baltimore, Maryland, United States, 21287
Contact: Daniele Rigamonti, MD     410-955-2259     dr@jhmi.edu    
Contact: Sachin Batra, Ph.D.     443-287-3648     sbatra1@jhmi.edu    
Principal Investigator: Daniele Rigamonti, MD            
Sponsors and Collaborators
Neuro Diagnostic Devices
Johns Hopkins University
Investigators
Principal Investigator: Daniele Rigamonti, MD Johns Hopkins School of Medicine
  More Information

Responsible Party: Johns Hopkins School of Medicine, Department of Neurosurgery ( Dr. Danieli Rigamonte )
Study ID Numbers: NDX01-22-2003
Study First Received: November 17, 2008
Last Updated: November 18, 2008
ClinicalTrials.gov Identifier: NCT00793416  
Health Authority: United States: Institutional Review Board

Keywords provided by Neuro Diagnostic Devices:
Normal Pressure Hydrocephalus
Valve Adjustment
Blocked Shunt in NPH patients
Diagnosis of blockage

Study placed in the following topic categories:
Pseudotumor cerebri
Pseudotumor Cerebri
Infant, Newborn, Diseases
Central Nervous System Diseases
Hydrocephalus, Normal Pressure
Hydrocephalus
Brain Diseases
Intracranial Hypertension
Hypertension

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009