Evaluating a device for measuring cerebrospinal fluid flow and headaches
Longitudinal Measurements of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device in People With Chronic Headaches
This study is testing a new device that measures the flow of cerebrospinal fluid in people with hydrocephalus to see if it can help understand their headaches better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 29 (estimated) |
| Ages | 6 Years to 80 Years |
| Sex | All |
| Sponsor | Rhaeos, Inc. Industry-sponsored |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06996600 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 6 to 80 years with an existing ventriculoperitoneal CSF shunt and experiencing at least 15 headache days per month.
Not a fit: Patients with multiple distal shunt catheters in the measurement region or those whose shunt is not palpable will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of headaches in patients with CSF shunts by providing a reliable method to assess shunt function.
How similar studies have performed: While this approach is innovative, there is limited information on the success of similar studies, indicating that this may be a novel assessment method.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Chicago, Illinois
- Rhaeos, Inc — Chicago, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: Anna Somera
- Email: clinical@rhaeos.com
- Phone: 855-814-3569
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.