# Noninvasive, wireless thermal sensors for the quantitative monitoring of ventricular shunt function in patients with hydrocephalus

> **NIH NIH U44** · RHAEOS, INC. · 2021 · $1,000,000

## Abstract

ABSTRACT
Hydrocephalus is a neurological disorder caused by buildup of excess cerebrospinal fluid (CSF)
in the brain, and leads to lethargy, seizures, coma, or death. It is treated with the surgical
implantation of a catheter, known as a ventricular shunt, that diverts excess CSF away from the
brain and into a distal absorptive site, such as the abdomen. Unfortunately, due to occlusion or
mispositioning, shunts have extremely high failure rates - 51% in 2 years, and 98% over 10
years - and often require corrective surgical procedures, known as revisions. 125,000 shunt
implantations or revisions are performed annually in the United States, at a cost of $2 billion.
Diagnosing shunt failure is extremely difficult, due the non-specific nature of its symptoms.
Imaging tests such as CT are commonly used despite their long-term radiation exposure risks
and invasive tests such as CSF aspiration and radionuclide tracing are painful and carry
significant infection risks. All the above tests have poor diagnostic performance, with low
sensitivities (~80%) and specificities (~55%), in large part because they do not directly measure
flow dynamics, arguably the most important and relevant shunt performance metric. The
continuous, non-invasive, real-time monitoring of CSF flow through implanted shunts represents
a critical unmet need. Clinicians would use these data for point-of-care diagnostics, and
researchers would use them to better understand shunt failure, and elucidate the
pathophysiology of poorly-understood conditions such as normal-pressure hydrocephalus.
The present proposal addresses this need by capitalizing on existing wireless sensor hardware
to develop the first skin mounted wireless product to give quantitative CSF flow data in
implanted shunts. Using precise measurements of thermal transport, we will develop novel
algorithms to characterize and quantify flow through underlying shunts with high accuracy.
Preliminary patient data, benchtop tests, and computer modeling confirm the ability of the
sensor to produce high-quality flow data while being mechanically unobtrusive to the patient.
Phase I activities will validate the sensor on large animal models, develop algorithms to deliver
quantitative flow data, and implement a quality management system to govern software
development, ultimately leading to IRB approval for clinical testing. Phase II activities will
validate diagnostic value of the sensor’s performance clinically through a human trial, ultimately
leading to a marketing submission to the FDA.

## Key facts

- **NIH application ID:** 10200529
- **Project number:** 1U44NS121555-01
- **Recipient organization:** RHAEOS, INC.
- **Principal Investigator:** Anna Lisa Somera
- **Activity code:** U44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $1,000,000
- **Award type:** 1
- **Project period:** 2021-09-15 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10200529

## Citation

> US National Institutes of Health, RePORTER application 10200529, Noninvasive, wireless thermal sensors for the quantitative monitoring of ventricular shunt function in patients with hydrocephalus (1U44NS121555-01). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10200529. Licensed CC0.

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