Thermal Measurement Device for Hydrocephalus

Overseen By Anna Somera

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Rhaeos, Inc.

Disqualifiers: Non-palpable shunt, Open wound, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device, the Wireless Thermal Anisotropy Measurement Device, which checks the function of a brain shunt (a tube that drains fluid from the brain) without surgery. The researchers aim to determine if the device can reliably measure fluid flow in individuals with hydrocephalus (a condition where fluid accumulates in the brain) during daily activities and sleep. The study seeks children and young adults with shunts, including those without recent shunt issues or those who had a shunt repair within the last week. Participants should have a shunt that is easily palpable under the skin. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance non-invasive monitoring for hydrocephalus patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on evaluating a device, so it's likely you can continue your medications, but please confirm with the study team.

What prior data suggests that this device is safe for assessing cerebrospinal fluid shunt flow?

Research has shown that the wireless device used to check the flow of fluid in the brain is safe. In previous studies, this device monitored the fluid without causing any major safety issues. No serious problems were reported during these trials, indicating that the device is well-tolerated. Designed for home use, it offers a convenient option for regular monitoring. This ensures participants can feel more comfortable about its safety when joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Wireless Thermal Anisotropy Measurement Device because it offers a non-invasive way to monitor the function of CSF shunts in pediatric hydrocephalus patients. Unlike current methods that often rely on imaging techniques or invasive procedures, this device uses thermal measurements to detect changes in the cerebrospinal fluid flow. This innovative approach could allow for quicker, easier detection of shunt issues, potentially improving patient safety and reducing the need for frequent hospital visits.

What evidence suggests that this device is effective for assessing CSF shunt flow in hydrocephalus patients?

This trial will evaluate a special wireless device designed to monitor cerebrospinal fluid (CSF) flow in shunts. Research has shown that this device effectively detects CSF flow in symptomatic patients. Participants will be divided into two groups: those with no recent shunt revision and those with a recent shunt revision. The non-invasive device checks shunt performance without surgery by sensing temperature changes to assess flow. This method helps identify potential issues early, which is crucial for managing hydrocephalus. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with hydrocephalus who are using a CSF shunt. The study aims to include participants willing to use the wireless thermal anisotropy measurement device during daily activities and sleep.

Inclusion Criteria

Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)

I am between 5 and 21 years old.

My ventricular size has been stable, and I've had no shunt issues or revisions for 2 years.

Exclusion Criteria

Prior enrollment in this study

Shunt is not palpable or depth of shunt where the device will be placed is greater than 4 mm per ultrasound evaluation

Subject-reported history of serious adverse skin reactions to silicone-based adhesives

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Device Assessment

Participants use the device to assess cerebrospinal fluid (CSF) shunt flow during activities of daily living and sleep

30 days

Follow-up

Participants are monitored for adverse device effects and usability post-study

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Wireless Thermal Anisotropy Measurement Device

Trial Overview The trial is testing a new wireless device that measures how well cerebrospinal fluid (CSF) flows through a shunt in patients with hydrocephalus, both during regular daily activities and while sleeping.

How Is the Trial Designed?

Group I: Recent Revision Experimental Treatment 1 Intervention

Pediatric hydrocephalus patients with an existing ventricular CSF shunt and a shunt revision in the previous 7 days who the investigator judges will likely be discharged within 4 days of the enrollment date will be enrolled.

Group II: No Recent Revision Experimental Treatment 1 Intervention

Pediatric hydrocephalus patients with an existing ventricular CSF shunt and a history of stable ventricular size, no shunt revision in the previous 2 years, and no current symptoms of shunt failure will be enrolled.

Who Is Running the Clinical Trial?

Rhaeos, Inc.

Lead Sponsor

Trials

11

Recruited

690+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT07050628

Study Details | NCT07050628 | Assessment of CSF Shunt ... Device : wireless thermal anisotropy measurement device. Wireless wearable thermal anisotropy measurement device designed for use at home. Participant Group ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40522244/

A Multicenter Study of Noninvasive Wireless Assessment ... This study established the performance of a first-generation wearable thermal anisotropy sensor in the identification of CSF shunt flow in symptomatic patients.

3. rhaeos.com rhaeos.com/wp-content/uploads/2025/06/Limbrick-2025.pdf

A Multicenter Study of Noninvasive Wireless Assessment of ... CONCLUSION: This study established the performance of a first-generation wearable thermal anisotropy sensor in the identification of CSF shunt ...

4. trialx.com trialx.com/clinical-trials/listings/236732/longitudinal-measurements-of-flow-in-cerebrospinal-fluid-shunts-with-a-wireless-thermal-anisotropy-measurement-device/?&geo_lat=41.9335&geo_lng=-88.0054&radius=10&place=Addison&user_country=United%20States

Longitudinal Measurements of Flow in Cerebrospinal Fluid ... Overview. This study evaluates the performance of a device for non-invasively assessing cerebrospinal fluid (CSF) shunt flow.

5. withpower.com withpower.com/trial/phase-hydrocephalus-10-2023-cd4fd

Wireless Shunt Flow Measurement Device for Hydrocephalus Research shows that wireless and noninvasive devices using thermal measurement can effectively monitor cerebrospinal fluid flow in shunts, helping to detect ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07050628

Study Details | NCT07050628 | Assessment of CSF Shunt ... Device : wireless thermal anisotropy measurement device. Wireless wearable thermal anisotropy measurement device designed for use at home.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05432986

Study Details | NCT05432986 | Assessment of CSF Shunt ... This study evaluates the performance of a non-invasive thermal measurement device for assessing CSF shunt flow.