Study of a Thermal Device for CSF Shunt Flow and Headaches

This study is looking at a new wireless thermal anisotropy measurement device to see if it can accurately measure the flow in cerebrospinal fluid (CSF) shunts. CSF shunts are tubes that help drain fluid from the brain in people with hydrocephalus. The study wants to see if the device's measurements of shunt flow are related to when you experience headaches. You might be able to join if you are between 6 and 80 years old, have an existing CSF shunt, and experience at least 15 headache days per month. The study aims to see how well the device's flow measurements match up with your headache reports over 30 days. The current recruitment status is unclear, and 29 people are planned to participate.

Study design
This is an interventional study planning to enroll 29 participants. It is testing a wireless thermal anisotropy measurement device.
What's involved
You would use the wireless thermal anisotropy measurement device at home to take multiple measurements during headache and non-headache periods.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 30 days, indicating a follow-up period of at least one month.

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NCT06996600

Assessment of CSF Shunt Flow and Headaches With a Thermal Measurement Device

Recruiting
NAAges 6–80InterventionalBasic science
Rhaeos, Inc.
~29 participants
Updated 2025-05-30 on ClinicalTrials.gov
What's tested:wireless thermal anisotropy measurement device

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Correlation Between Study Device Flow Measurement and Subject-reported Headaches
Measured over 30 days
Hydrocephalus
1 sites across 1 states
Illinois1

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  • Correlation Between Study Device Flow Measurement and Subject-reported Headaches30 days

    Exploratory analysis to determine the relationship between headaches (subject-reported headache and non-headache periods) and measured flow. Data will be analyzed using the Point-Biserial Correlation Coefficient between headaches periods (headache and non-headache periods) and thermal flow score (flow score derived from algorithm analysis of raw thermal data)