The goal of this SBIR is to create the first comprehensive set of clinical tools and noninvasive methods for diagnosing cerebrospinal fluid (CSF) shunt obstruction and to validate them to convince clinicians of their clinical value. Hydrocephalus is a common condition in which CSF accumulates in the brain ventricles, potentially leading to brain damage and death. It is corrected by placing a VP shunt that carries excess CSF away. Although enormously successful, shunts eventually fail, usually by obstruction. However, the clinical symptoms of shunt obstruction, primarily including headache and nausea, are non-specific, making shunt failure challenging to diagnose. Suspected obstruction is typically investigated using static MRI and CT scans which are expensive, and require evidence of fluid accumulation in serial images, precluding prediction of shunt failure. Exposure to radiation is also significant in shunted children, who may require several shunt investigations annually. Radionuclide studies, which provide dynamic measures of shunt CSF flow, are invasive and carry the risk of infection. They also have reduced diagnostic specificity due to intermittent shunt flow - patent shunts do not flow continuously leading to a high level of false positive readings. A new, non- invasive test for shunt flow, ShuntCheck, also suffers from reduced specificity due to intermittent shunt flow, leading to questions about the device's accuracy. There are currently no tools for differentiating between intermittently flowing patent shunts and occluded shunts. NeuroDx Development (NeuroDx) has recently developed and bench tested "Micro-Pumper", a small device which is held against the shunt valve during the ShuntCheck test. The device provides specific vibration pulses to the valve, creating a controlled level of CSF flow through the valve. We have shown that the Micro-Pumper, used in combination with ShuntCheck can differentiate between non-flowing patent shunts and occluded or partially occluded shunts. The goal of this Phase 1 project is to validate the accuracy of the ShuntCheck flow/no-flow determination via comparison to MRI flow testing and to test the Micro-Pumper/ShuntCheck combination in a pilot study or pediatric hydrocephalus patients at Children's Hospital Boston. By the end of Phase 2, we anticipate having accumulated sufficient data to enable submission of a pre-market notification (510(k)) to the FDA for the Micro- Pumper (in conjunction with ShuntCheck). The result of this work will be an important change in the diagnostic algorithm currently used to manage hydrocephalus 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 diagnostic procedure 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 creating the first comprehensive set of clinical tools and noninvasive methods for diagnosing cerebrospinal fluid (CSF) shunt obstruction and validating them to convince clinicians of the valuable information available from ShuntCheck(R) (SC) and Micro-Pumper. Obstruction of CSF shunts, a common complication, is currently diagnosed by radiation imaging techniques, such as CT Scan, or by invasive procedures, such as shunt tapping. These new tools will enable shunt obstruction to be diagnosed and will provide a research tool for understanding shunt function.
Thesaurus Terms: 0-11 Years Old; Acquired Brain Injury; Address; Algorithms; Biosensor; Boston; Brain Injuries; Brain Ventricle; Brain Imaging; Cat Scan, X-Ray; Cat Scan; Csf Shunt; Ct X Ray; Ct Scan; Cardiac; Cephalalgia; Cephalgia; Cephalodynia; Cephalodynias; Cerebral Ventricles; Cerebrospinal Fluid; Cerebrospinal Fluid Shunts; Cerebrospinal Fluid Shunt (Csf) Procedure; Cerebrospinal Fluid Shunts Procedure; Cessation Of Life; Child; Child Youth; Childhood; Children (0-21); City Of Boston; Clinical; Clinical Evaluation; Clinical Testing; Collaborations; Communities; Complication; Computed Tomography; Computerized Axial Tomography (Computerized Tomography); Computerized Tomography, X-Ray; Cranial Pain; Data; Death; Development; Device Or Instrument Development; Devices; Diagnosis; Diagnostic; Diagnostic Method; Diagnostic Procedure; Diagnostic Specificity; Diagnostic Technique; Emi Scan; Exposure To; Flr; Failure (Biologic Function); Fear; Fright; Goals; Hosp; Head Pain; Headache; Hospitals; Human, Child; Hydrocephalus; Hydrocephaly; Image; Imaging Procedures; Imaging Techniques; Individual; Infection; Investigation; Job Environment; Job Location; Job Place; Job Setting; Job Site; Label; Legal Patent; Life; Liquid Substance; Mr Imaging; Mr Tomography; Mri; Magnetic Resonance Imaging; Magnetic Resonance Imaging Scan; Marketing; Measures; Medical Device; Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance; Methods; Methods And Techniques; Methods, Other; Modality; Nmr Imaging; Nmr Tomography; Nature; Nausea; Notification; Nuclear Magnetic Resonance Imaging; Obstruction; Operation; Operative Procedures; Operative Surgical Procedures; Out-Patients; Outcome; Outpatients; Patents; Patients; Pediatric Hospitals; Performance; Phase; Physiologic Pulse; Pilot Projects; Procedures; Program Development; Pulse; Radiation; Radioactive Isotopes; Radioisotopes; Radionuclides; Reading; Research; Research Design; Risk; Sbir; Sbirs (R43/44); Safety; Sample Size; Savings; Shunt; Shunt Device; Skin Temperature; Small Business Innovation Research; Small Business Innovation Research Grant; Specificity; Study Type; Surgical; Surgical Interventions; Surgical Procedure; Symptoms; Technics, Imaging; Techniques; Technology; Temperature; Testing; Time; Tomodensitometry; Tomography, Xray Computed; Uncertainty; Validation; Vibration; Vibration - Physical Agent; Work; Work Location; Work Place; Work-Site; Workplace; Worksite; X-Ray Computed Tomography; Zeugmatography; Base; Brain Damage; Brain Lesion (From Injury); Brain Visualization; Catscan; Cerebrospinal Fluid Flow; Children; Clinical Decision-Making; Clinical Test; Computed Axial Tomography; Computerized Axial Tomography; Computerized Tomography; Device Development; Doubt; Experience; Failure; Fluid; Fluid Flow; Imaging; Improved; Innovate; Innovation; Innovative; Instrument Development; Liquid; Mathematical Algorithm; Meetings; Pediatric; Pilot Study; Public Health Relevance; Ray (Radiation); Repair; Repaired; Research Clinical Testing; Sensor (Biological); Shunts; Spinal Fluid; Study Design; Surgery; Tool; Vibration; Work Environment; Work Setting; Youngster
