ShuntCheck vs radionuclide shunt testing for suspected obstruction in adults 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 compares the diagnostic accuracy of ShuntCheck to radionuclide shunt patency testing in patients with normal pressure hydrocephalus and suspected shunt obstruction. Participants are adults aged 40 and older with a ventriculoperitoneal shunt. The study analyzes how well ShuntCheck identifies shunt patency or obstruction relative to the standard SPS method. It focuses on measuring sensitivity and specificity in detecting CSF flow through the shunt. The lead site is the University of South Florida, with NeuroDx Development as a collaborator.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Men or women 40 yo or older and have a VP shunt placed for NPH and are suspected of shunt obstruction.
* Capable of providing valid signed informed consent, or has a legal guardian, health care agent, or surrogate decision maker (according to local statutes, and collectively referred to as "surrogates" in this protocol) 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 VP 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.