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

This study has been terminated.
(Loss of study staffing)
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by (Responsible Party):
NeuroDx Development
ClinicalTrials.gov Identifier:
NCT00793416
First received: November 17, 2008
Last updated: November 7, 2012
Last verified: November 2012
History of Changes
  Purpose

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 Intervention Phase
Normal Pressure Hydrocephalus
 Device: Shunt flow detection
 Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Accuracy of ShuntCheck and MRI in Detection of Shunt Obstruction in Patients Receiving Shunt Patency Test

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by NeuroDx Development:

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 shunt revision surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 6
Study Start Date: November 2008
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  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
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
NeuroDx Development
Johns Hopkins University
Investigators
Principal Investigator: Daniele Rigamonti, MD Johns Hopkins School of Medicine
  More Information

No publications provided

Responsible Party: NeuroDx Development
ClinicalTrials.gov Identifier: NCT00793416     History of Changes
Other Study ID Numbers: NDX01-22-2003
Study First Received: November 17, 2008
Last Updated: November 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by NeuroDx Development:
Normal Pressure Hydrocephalus
Valve Adjustment
Blocked Shunt in NPH patients
Diagnosis of blockage

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

ClinicalTrials.gov processed this record on May 19, 2013