Thermal Measurement Device for Hydrocephalus

Overseen By Anna Somera

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Rhaeos, Inc.

Disqualifiers: Multiple shunt catheters, Deep shunt, Open wound, Silicone allergy, others

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

Compensation: Varies

Number of Visits: Unknown

29 Participants Needed

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 measures how well a shunt (a tube used to drain fluid) functions in people with hydrocephalus, especially during headaches. The goal is to determine if the device can track changes in cerebrospinal fluid (CSF) flow without surgery. It targets individuals with hydrocephalus who already have a shunt and experience frequent headaches—at least 15 days a month. As an unphased trial, this study allows participants to contribute to innovative research that could enhance non-surgical monitoring of shunt function.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

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

Research has shown that wireless and non-invasive devices, like the one under study, can effectively monitor cerebrospinal fluid (CSF) flow in shunts. This capability helps identify problems without surgery or other invasive methods.

One study found these devices to be generally safe and easy for patients to use in daily life. As the device is non-invasive, it does not require insertion into the body, reducing the risk of complications.

Studies involving similar devices have reported no serious side effects, suggesting the treatment is well-tolerated by patients. ^{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 novel way to manage chronic headaches in hydrocephalus patients with shunts. Unlike standard treatments that typically involve medication adjustments or surgical revisions, this device provides a non-invasive method to measure temperature changes that can indicate shunt function. By using wireless technology, it allows for real-time monitoring and potentially quicker interventions if a problem is detected. This could lead to better management of symptoms and improve the quality of life for patients who suffer from frequent headaches.

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

Research has shown that a new wireless device, used by participants in this trial, can effectively monitor cerebrospinal fluid (CSF) shunt flow. Studies have found that this non-invasive sensor accurately detects shunt flow in symptomatic patients. By using heat to track fluid movement, the device helps identify shunt issues. Early results suggest it could be a reliable tool for patients with hydrocephalus who experience headaches, potentially reducing the need for invasive tests. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for individuals with hydrocephalus who experience headaches. Participants will use a wireless device to measure CSF shunt flow during headache and non-headache periods. Specific eligibility criteria are not provided, but typically include being diagnosed with the condition and consenting to participate.

Inclusion Criteria

Existing ventriculoperitoneal CSF shunt

I have had headaches on most days for the last 3 months.

I can attend both remote and in-person follow-ups for 30 days.

Exclusion Criteria

Investigator judges that the subject is unlikely to successfully take reliable measurements at home

Prior enrollment in this study

Presence of more than one distal shunt catheter in the study device measurement region

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Measurement

Participants use the device to measure cerebrospinal fluid (CSF) shunt flow during headache and non-headache periods

4 weeks

Multiple self-administered measurements

Follow-up

Participants are monitored for safety and effectiveness after the measurement period

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Wireless Thermal Anisotropy Measurement Device

Trial Overview The study is testing a wireless thermal anisotropy measurement device's ability to assess cerebrospinal fluid (CSF) shunt flow in patients with hydrocephalus. The device will be used by participants themselves at different times to monitor changes.

How Is the Trial Designed?

Group I: CSF Shunted Patients with Chronic Headaches Experimental Treatment 1 Intervention

hydrocephalus patients with an existing ventriculoperitoneal (VP) shunt who experience chronic headaches, defined as ≥15 headache episodes/month for ≥3 months

Who Is Running the Clinical Trial?

Rhaeos, Inc.

Lead Sponsor

Trials

11

Recruited

690+

Citations

1. 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. Patients with an existing implanted shunt and ...

2. 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 ...

3. 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.

4. withpower.com withpower.com/trial/thermal-measurement-device-for-hydrocephalus-89243

Thermal Measurement Device for Hydrocephalus This trial is for individuals with hydrocephalus who experience headaches. Participants will use a wireless device to measure CSF shunt flow during headache and ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0956566325002234

Evaporative cooling for low-cost monitoring of flow ... A compact device with Bluetooth Low Energy (BLE) capabilities and a small battery allows both intermittent evaluations and continuous monitoring.

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

Study Details | NCT07050628 | Assessment of CSF Shunt ... Assessment of CSF Shunt Flow During Activities of Daily Living and Sleep With a Thermal Measurement Device. ClinicalTrials.gov ID NCT07050628.

7. 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 ... This study evaluates the performance of a device for non-invasively assessing cerebrospinal fluid (CSF) shunt flow. Patients with an existing ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7060317/

Continuous, noninvasive wireless monitoring of flow ... Unfortunately, shunts have extremely high failure rates and diagnosing shunt malfunction is challenging due to a combination of vague symptoms ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT06410885

Assessment of Flow in Cerebrospinal Fluid Shunts With a ... This study evaluates the performance of the study device, FlowSense®, a sensor for non-invasively assessing cerebrospinal fluid (CSF) shunt flow. Subjects with ...

10. 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 ...