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ShuntCheck Accuracy in Detecting Shunt Obstruction Normal Pressure Hydrocephalus (NPH) Patients

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: NCT00793416
Recruitment Status : Withdrawn (Loss of study staffing)
First Posted : November 19, 2008
Last Update Posted : October 29, 2013
Johns Hopkins University
Information provided by (Responsible Party):
NeuroDx Development

Brief Summary:
The purpose of this study is to examine the role of ShuntCheck and MR Imaging in evaluating the presence or absence of Shunt Obstruction in the patients of Hydrocephalus or Idiopathic Intracranial Hypertension (IIH) undergoing radionuclide test for suspected shunt obstruction. This is an exploratory study to determine how a non-invasive device can assist in detection of presence of flow in these patients.

Condition or disease Intervention/treatment Phase
Normal Pressure Hydrocephalus Device: Shunt flow detection Phase 4

Detailed Description:

This study aims to correlate findings of ShuntCheck and MRI with the Radionuclide patency study. Patients will be enrolled if they have Hydrocephalus or IIH, present with symptoms of shunt obstruction and will need to undergo shunt patency test and an MRI along with standard of care radionuclide study. The ShuntCheck study will be conducted in a clinic, doctor's office or in an emergency room by the treating physician or by trained health care professionals.

Also, patients who are found with shunt obstruction as diagnosed by Radionuclide study will undergo shunt revision and the findings of the study will be correlated with operative findings. Post Shunt replacement patients who also receive adjustable valve will be evaluated with shunt Check, before and after adjustment of valves to detect changes in flow as detected by shunt check.

This is an exploratory study to determine how a non-invasive device can assist in detection of presence of flow in these patients.

Approximately 20 subjects will be enrolled in a single site in this proof of concept, physician sponsored study. An approved, commercial device will be available to the site prior to start of the study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Accuracy of ShuntCheck and MRI in Detection of Shunt Obstruction in Patients Receiving Shunt Patency Test
Study Start Date : November 2008
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hydrocephalus

Arm Intervention/treatment
Experimental: ShuntCheck measure
All patients will have ShuntCheck measurements along with radionuclide shunt patency testing.
Device: Shunt flow detection
Shunt flow detection based upon ShuntCheck results compared to radionuclide test results

Primary Outcome Measures :
  1. Exploratory Evaluation of the Utility of ShuntCheck in detection of ShuntFlow in patients admitted with potential shunt obstruction [ Time Frame: Pre and post shunt revision surgery ]

Secondary Outcome Measures :
  1. To assess any adverse events that arise from conducting ShuntCheck test To assess the cost effectiveness of ShuntCheck screening upon completion of the study [ Time Frame: Pre and post shunt revision surgery ]

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.

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Ages Eligible for Study:   35 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT00793416

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United States, Maryland
Johns Hopkins Medical Center
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
NeuroDx Development
Johns Hopkins University
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Principal Investigator: Daniele Rigamonti, MD Johns Hopkins School of Medicine
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Responsible Party: NeuroDx Development Identifier: NCT00793416    
Other Study ID Numbers: NDX01-22-2003
First Posted: November 19, 2008    Key Record Dates
Last Update Posted: October 29, 2013
Last Verified: October 2013
Keywords provided by NeuroDx Development:
Normal Pressure Hydrocephalus
Valve Adjustment
Blocked Shunt in NPH patients
Diagnosis of blockage
Additional relevant MeSH terms:
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Hydrocephalus, Normal Pressure
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases