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.
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.
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.
The study population will consist of asymptomatic normal pressure hydrocephalus research subjects who have a ventriculoperitoneal shunt with a single ventricular catheter implanted for adult hydrocephalus and are visiting for routine care. Evaluation will be within 2 weeks of shunt placement.
Cohort
Prospective
ShuntCheck
Diagnostic testThe intervention is an FDA-cleared device utilizing a transcutaneous thermal convection to analyze shunt flow.
Specificity of ShuntCheck test
Negative Predictive Value of ShuntCheck test
Specificity of performing ShuntCheck test twice
Negative Predictive Value of performing ShuntCheck test twice
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University of South Florida
Lead sponsor
NeuroDx Development
Collaborator
