Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


NCT number NCT00793416
Study type Interventional
Source NeuroDx Development
Contact
Status Withdrawn
Phase Phase 4
Start date November 2008
Completion date August 2012

See also
  Status Clinical Trial Phase
Terminated NCT00149721 - Anterior Pituitary Function in Patients With Hydrocephalus N/A
Completed NCT00196196 - A Precision and Accuracy Study of the Codman Valve Position Verification (VPV) System. Phase 3
Not yet recruiting NCT05562596 - Normal Pressure Hydrocephalus Biomarkers Investigation
Completed NCT00233701 - Normal Pressure Hydrocephalus (NPH) Registry Phase 4
Unknown status NCT00874198 - European Study on Prediction of Outcome in Patients With Idiopathic Normal Pressure Hydrocephalus N/A
Recruiting NCT05910944 - European Study of Prodromal iNPH
Active, not recruiting NCT01909960 - Flow MRI in Normal Pressure Hydrocephalus N/A
Completed NCT02016352 - Cerebrospinal Fluid Proteome in Hydrocephalus N/A
Terminated NCT01092546 - Positron Emission Tomography Imaging of Brain Amyloid in Normal Pressure Hydrocephalus Phase 3
Terminated NCT00613886 - Factors Predicting Response to Shunting in Normal Pressure Hydrocephalus N/A
Completed NCT01815775 - Predictive Value of Flow MRI in Normal Pressure Hydrocephalus Surgery Phase 0
Recruiting NCT03877107 - Effect of Depletive Lumbar Puncture on Lower Urinary Tract Dysfunction in iNPH N/A
Enrolling by invitation NCT03269201 - Brain Network Activation in Patients With Movement Disorders
Recruiting NCT03245138 - Endoscopic Third Ventriculostomy Versus Ventriculo-peritoneal Shunting in Idiopathic Normal Pressure Hydrocephalus N/A
Terminated NCT00727142 - Conservative Versus Surgical Management of Idiopathic Normal Pressure Hydrocephalus (INPH) N/A
Recruiting NCT04471740 - Normal Pressure Hydrocephalus and Sleep Apnea N/A
Completed NCT01798641 - A Randomized Cross-over Study for Normal Pressure Hydrocephalus N/A
Recruiting NCT01618500 - Computerised Testing of Cognitive Response to Cerebrospinal Fluid Shunting in Idiopathic Normal Pressure Hydrocephalus N/A
Completed NCT00600795 - Prognostic Value of Transforming Growth Factor-Beta 1 in Normal Pressure Hydrocephalus N/A
Terminated NCT03521518 - CPT-3 in Normal Pressure Hydrocephalus