ShuntCheck performance in people with normal pressure hydrocephalus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study evaluates the performance characteristics of the ShuntCheck test in detecting flow status of a ventriculoperitoneal shunt among asymptomatic adults 40 and older who are receiving routine care for normal pressure hydrocephalus. Participants have a VP shunt and are evaluated during standard clinic visits; the test results are compared with the shunt’s usual management context. The study is conducted at the University of South Florida with NeuroDx Development as a collaborator. It seeks to determine how accurately ShuntCheck identifies flow versus no flow without altering standard patient care. No treatment or intervention beyond the ShuntCheck test is involved.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of South Florida Department of Neurological Surgery and Brain Repair
  Tampa, Florida, United States Recruiting

Study contacts

• Principal investigator: Naomi Abel, MD — University of South Florida
• Study coordinator: Naomi Abel, MD
• Email: nabel@usf.edu
• Phone: 813 259-0904

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.