Actively Recruiting
Longitudinal Measurements of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device in People With Chronic Headaches
Led by Rhaeos, Inc. · Updated on 2025-05-30
29
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate a wireless thermal anisotropy measurement device designed to non-invasively assess cerebrospinal fluid (CSF) shunt flow in people with hydrocephalus who experience chronic headaches. The study focuses on patients with existing ventriculoperitoneal (VP) shunts and frequent headache episodes, exploring the relationship between device measurements and headache occurrences. The study does not involve masking or placebo controls, and it is sponsored by Rhaeos, Inc. Participants will use a wearable device at home to measure CSF shunt flow across multiple sessions during periods with and without headaches. The device is designed to be applied over the shunt region where the skin is intact and the shunt is palpable. This study period lasts 30 days, during which participants will perform regular measurements remotely and attend in-person follow-ups as needed. Throughout the study, participants will record headache symptoms and device measurement data, which researchers will correlate to understand flow patterns. The main outcome is the correlation between device flow measurements and subject-reported headaches over 30 days. The study involves ongoing communication and symptom documentation in English, with safety and adherence monitored remotely and in-person during the measurement period. Participation lasts for the 30-day measurement and follow-up timeframe.
CONDITIONS
Brief Title
Assessment of CSF Shunt Flow and Headaches With a Thermal Measurement Device
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Existing ventriculoperitoneal cerebrospinal fluid (CSF) shunt
- Experiencing ongoing headaches with at least 15 headache days per month for the past 3 months
- Intact skin over a clearly identifiable palpable ventricular shunt crossing the clavicle suitable for device placement
- Available for remote and in-person follow-up during the 30-day measurement period
- Signed informed consent by the subject or authorized representative
- Ability to communicate and document symptoms clearly in English
- Age between 6 and 80 years old
You will not qualify if you...
- More than one distal shunt catheter in the device measurement area
- Shunt not palpable due to depth greater than 4 mm by ultrasound evaluation
- Presence of open wound or swelling in the device measurement area
- History of serious adverse skin reactions to silicone-based adhesives
- Likely to be lost to follow-up or have unobtainable clinical outcome
- Unlikely to perform reliable at-home measurements
- Unable to place the device without assistance
- Use of the device would interfere with standard care or emergency surgery
- Previous participation in this study
- Participation in other investigational studies affecting data validity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 30 days
Participants use the wireless thermal anisotropy measurement device at home to measure cerebrospinal fluid shunt flow.
Remote and in-person follow-up during the 30-day measurement period
Trial Site Locations
Total: 1 location
1
Rhaeos, Inc
Chicago, Illinois, United States, 60642
Actively Recruiting
Research Team
A
Anna Somera
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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