![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
Sponsors and Collaborators: |
Neuro Diagnostic Devices Johns Hopkins University |
---|---|
Information provided by: | Neuro Diagnostic Devices |
ClinicalTrials.gov Identifier: | NCT00793416 |
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 |
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 |
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
|
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.
Ages Eligible for Study: | 35 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Principal Investigator: | Daniele Rigamonti, MD | Johns Hopkins School of Medicine |
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 |
Normal Pressure Hydrocephalus Valve Adjustment Blocked Shunt in NPH patients Diagnosis of blockage |
Pseudotumor cerebri Pseudotumor Cerebri Infant, Newborn, Diseases Central Nervous System Diseases Hydrocephalus, Normal Pressure |
Hydrocephalus Brain Diseases Intracranial Hypertension Hypertension |
Nervous System Diseases |