This Phase 1 SBIR will develop a non-invasive alternative to radionuclide shunt patency testing for evaluating Normal Pressure Hydrocephalus (NPH) patients with suspected shunt malfunction. Hydrocephalus is a disorder of cerebrospinal fluid dynamics that is commonly treated by placing a shunt that carries excess fluid from the brain to the abdomen. While this treatment is generally successful, shunts inevitably fail, usually by obstruction. The clinical signs of shunt obstruction, the gradual decline into dementia-like symptoms, make shunt failure challenging to diagnose. Suspected obstruction in NPH patients is typically investigated using an invasive radionuclide shunt patency study. There are currently no non-invasive, non- radiological techniques for the early diagnosis of shunt obstruction. NeuroDx Development (NeuroDx) is developing a tool, ShuntCheck, for rapid, non-invasive measurement of CSF flow through a VP shunt by transcutaneous temperature detection as cooled CSF moves through the shunt tubing. The resulting hand-held device is a convenient method for rapidly determining shunt function. Key to translating this device into the NPH clinic is the completion of a clinical validation study to compare the device's diagnostic sensitivity and specificity to radionuclide testing. The goal of this Phase 1 project is to complete a 25 patient clinical study of ShuntCheck compared to radionuclide. In Phase 2, we anticipate conducting a multi-center outcomes study of ShuntCheck as a shunt patency test for NPH patients. This study will be conducted as a pivotal trial and will be used to support expanded labeling for ShuntCheck. The result of this study could be an important change in the diagnostic algorithm currently used to manage symptomatic NPH patients. Given the need for a non-invasive method to accurately diagnose shunt failure, the potential savings over alternative methods and the potential for improved patient outcomes, the data from this study will support a product which is commercially viable and extremely important.
Public Health Relevance: This proposal addresses the need for diagnostic tools for use in a hospital or outpatient setting that work in real-time to quantitatively determine shunt function by supporting a clinical study comparing the accuracy of a non-invasive device, ShuntCheck, to the current invasive gold standard, radionuclide testing, in diagnosing shunt malfunction in adult normal pressure hydrocephalus (NPH) patients. The results of this study could support an important change in the standard diagnostic pathway currently used to manage symptomatic NPH patients.
Thesaurus Terms: 21+ Years Old;Abbreviations;Abdomen;Abdominal;Accident And Emergency Department;Accuracy Of Diagnosis;Address;Adult;Algorithms;Amentia;Animal Model;Animal Models And Related Studies;Au Element;Biomedical Engineering;Blinded;Brain;Brain Ventricle;Cat Scan, X-Ray;Cat Scan;Csf Shunt;Ct X Ray;Ct Scan;Cerebral Ventricles;Cerebrospinal Fluid;Cerebrospinal Fluid Shunts;Cerebrospinal Fluid Shunt (Csf) Procedure;Cerebrospinal Fluid Shunts Procedure;Characteristics;Clinic;Clinical;Clinical Investigator;Clinical Research;Clinical Study;Clinical Trials;Clinical Trials, Unspecified;Computed Tomography;Computer Programs;Computer Software;Computerized Axial Tomography (Computerized Tomography);Computerized Tomography, X-Ray;Creation Of Ventriculo-Peritoneal Shunt;Data;Dementia;Detection;Development;Devices;Diagnosis;Diagnostic;Diagnostic Sensitivity;Diagnostic Specificity;Disease;Disorder;Double-Blind Method;Double-Blind Study;Double-Blinded;Double-Masked Method;Double-Masked Study;Drops;Emi Scan;Early Diagnosis;Emergency Department;Emergency Room;Encephalon;Encephalons;Enrollment;Flr;Failure (Biologic Function);Gait;Gamma Camera Imaging;Goals;Gold;Hosp;Hakim Syndrome;Hand;Hospitals;Housing;Human, Adult;Hydrocephalus;Hydrocephalus, Normal Pressure;Hydrocephaly;Image;Impairment;Infection;Injection Of Therapeutic Agent;Injections;Job Environment;Job Location;Job Place;Job Setting;Job Site;Label;Liquid Substance;Measurement;Measures;Methods;Methods And Techniques;Methods, Other;Monitor;Movement;Nph;Nphs (Normal Pressure Hydrocephalus);Nervous System, Brain;Neurosurgeon;Normal Pressure Hydrocephalus;Obstruction;Out-Patients;Outcome;Outcome Study;Outpatients;Pathway Interactions;Patients;Performance;Peritoneal;Phase;Pilot Projects;Position;Positioning Attribute;Pressure;Pressure- Physical Agent;Printing;Procedures;Process;Radioactive Isotopes;Radioisotopes;Radionuclide Imaging;Radionuclides;Relative;Relative (Related Person);Risk;Sae;Sbir;Sbirs (R43/44);Sched;Savings;Scanning, Radioisotope;Schedule;Scintigraphy;Screening Result;Sensitivity And Specificity;Serious Adverse Event;Shunt;Shunt Device;Skin Temperature;Small Business Innovation Research;Small Business Innovation Research Grant;Software;Specificity;Symptoms;Syndrome;Techniques;Temperature;Test Result;Testing;Time;Tomodensitometry;Tomography, Xray Computed;Translating;Translatings;Urgency Of Micturition;Urgency To Pass Urine;Urgent Desire To Urinate;Urinary Incontinence;Validation;Ventriculo-Peritoneal Shunt;Ventriculoperitoneal Shunt;Work Location;Work Place;Work-Site;Workplace;Worksite;X-Ray Computed Tomography;Adult Human (21+);Base;Bioengineering;Bioengineering /Biomedical Engineering;Bioengineering/Biomedical Engineering;Blind;Body Movement;Catscan;Clinical Investigation;Computed Axial Tomography;Computer Program /Software;Computer Program/Software;Computerized Axial Tomography;Computerized Tomography;Design;Designing;Diagnostic Accuracy;Disease /Disorder;Disease/Disorder;Early Detection;Enroll;Experience;Failure;Fluid;Fluid Flow;Human Study;Imaging;Improved;Language Translation;Liquid;Micturition Urgency;Model Organism;Pathway;Pilot Study;Pressure;Prospective;Radionuclide Imaging /Scanning;Radionuclide Imaging/Scanning;Radionuclide Scanning;Shunts;Spinal Fluid;Standard Of Care;Subcutaneous;Surgeon, Neuro-;Tool;Urinary Urgency;Urination Urgency;Validation Studies;Work Environment;Work Setting;Work Site
