Assessment of CSF Shunt Flow and Headaches With a Thermal Measurement Device (NCT06996600) | Clinical Trial Compass
RecruitingNot Applicable
Assessment of CSF Shunt Flow and Headaches With a Thermal Measurement Device
United States29 participantsStarted 2025-05-02
Plain-language summary
This study evaluates the performance of a device for non-invasively assessing cerebrospinal fluid (CSF) shunt flow over multiple measurements performed by a study subject during headache and non-headache periods.
Who can participate
Age range
6 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Existing ventriculoperitoneal CSF shunt
. Subject experiencing ongoing headaches including at least 15 headache days per month for the past 3 months
. Region of intact skin overlying an unambiguously identifiable palpable chronically indwelling ventricular shunt which crosses the clavicle and is appropriate in size for application of the study device
. Available for remote and in-person follow-up during the 30-day measurement period
. Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
. Subject or caregiver is able to clearly communicate and document information and shunt symptoms in English
. Subject is at least 6 years old but not more than 80 years old
Exclusion criteria
. Presence of more than one distal shunt catheter in the study device measurement region
. Shunt is not palpable due to depth or depth of shunt where the device will be placed is greater than 4 mm per ultrasound evaluation
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Correlation Between Study Device Flow Measurement and Subject-reported Headaches
. Presence of an interfering open wound or edema in the study device measurement region
. Subject-reported history of serious adverse skin reactions to silicone-based adhesives
. Investigator judges that the subject is likely to be lost to follow-up due to unavailability or clinical outcome being unobtainable
. Investigator judges that the subject is unlikely to successfully take reliable measurements at home
. Investigator judges that the subject/subject's caretaker would not be able to successfully place the device without assistance
. Use of the study device would interfere with standard patient care, or emergency surgery that cannot be delayed, or participation in the study will interfere with, or be detrimental to, administration of optimal healthcare to the subject