Evaluating a device for measuring cerebrospinal fluid flow and headaches

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study assesses a wireless thermal anisotropy measurement device designed to non-invasively evaluate cerebrospinal fluid (CSF) shunt flow in patients with hydrocephalus. Participants will undergo multiple measurements during both headache and non-headache periods to determine the device's effectiveness. The study aims to gather data on shunt performance and its correlation with headache symptoms over a 30-day measurement period. Eligible subjects must have an existing ventriculoperitoneal CSF shunt and experience frequent headaches.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Existing ventriculoperitoneal CSF shunt
2. Subject experiencing ongoing headaches including at least 15 headache days per month for the past 3 months
3. 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
4. Available for remote and in-person follow-up during the 30-day measurement period
5. Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
6. Subject or caregiver is able to clearly communicate and document information and shunt symptoms in English
7. Subject is at least 6 years old but not more than 80 years old

Exclusion Criteria:

1. Presence of more than one distal shunt catheter in the study device measurement region
2. 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
3. Presence of an interfering open wound or edema in the study device measurement region
4. Subject-reported history of serious adverse skin reactions to silicone-based adhesives
5. Investigator judges that the subject is likely to be lost to follow-up due to unavailability or clinical outcome being unobtainable
6. Investigator judges that the subject is unlikely to successfully take reliable measurements at home
7. Investigator judges that the subject/subject's caretaker would not be able to successfully place the device without assistance
8. 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
9. Prior enrollment in this study
10. Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study

Where it's running

• Rhaeos, Inc
  Chicago, Illinois, United States Recruiting

Study contacts

• Study coordinator: Anna Somera
• Email: clinical@rhaeos.com
• Phone: 855-814-3569

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Wearable sensor to detect CSF flow in shunt tubing

  This will test a small, wireless skin sensor to see if it can detect cerebrospinal fluid (CSF) flow through implanted shunts in children and adults with stable hydrocephalus.

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• CSF lactate and other biomarkers in patients with an external ventricular drain after acute brain injury

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• See if a wireless thermal device can measure CSF shunt flow during daily activities and sleep

  A wireless thermal device is being tested to see if it can non-invasively monitor CSF shunt flow in people with hydrocephalus during everyday activities and sleep.

  Recruiting at 2 sites Rhaeos, Inc. · Chicago, Illinois and 1 other locations · NCT07050628

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.