Hydrocephalus, Normal Pressure
Conditions
Keywords
Asymptomatic Normal Pressure Hydrocephalus, Ventriculoperitoneal Shunt
Brief summary
The purpose of the study is to determine if the ShuntCheck test can correctly identify flow or no flow in a ventriculoperitoneal shunt in patients with asymptomatic normal pressure hydrocephalus.
Interventions
DIAGNOSTIC_TESTShuntCheck
The intervention is an FDA-cleared device utilizing a transcutaneous thermal convection to analyze shunt flow.
Sponsors
University of South Florida
NeuroDx Development
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Asymptomatic men or women 40 years old or older and have a ventriculoperitoneal shunt placed for normal pressure hydrocephalus and are visiting for routine care. * Capable of providing valid signed informed consent, or has a legal guardian, health care agent, or surrogate decision maker capable of providing valid, signed informed consent.
Exclusion criteria
* Presence of multiple shunts, or presence of more than one distal shunt catheter (regardless of function) crossing the clavicle ipsilateral to the shunt with suspected obstruction; * ShuntCheck test would interfere with standard patient care, or emergency shunt surgery that cannot be delayed is indicated; * Presence of an interfering open wound or edema over any portion of the ventriculoperitoneal shunt.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Specificity of ShuntCheck test | 15 minutes |
| Negative Predictive Value of ShuntCheck test | 15 minutes |
Secondary
| Measure | Time frame |
|---|---|
| Specificity of performing ShuntCheck test twice | 60 minutes |
| Negative Predictive Value of performing ShuntCheck test twice | 60 minutes |
Countries
United States
Contacts
CONTACTNaomi Abel, MD
CONTACTRachel Karlnoski, MD
PRINCIPAL_INVESTIGATORNaomi Abel, MD
University of South Florida
Outcome results
None listed