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.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Assessment of CSF Shunt Flow and Headaches With a Thermal Measurement Device
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- 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)