Recruiting NCT06996600
Assessment of CSF Shunt Flow and Headaches With a Thermal Measurement Device
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: wireless thermal anisotropy measurement device.
- Who it may be relevant to
- Registry conditions: Hydrocephalus. Basic parameters: 6 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Longitudinal Measurements of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device in People With Chronic Headaches
Overview
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.
Interventions
- Device wireless thermal anisotropy measurement device
Wireless wearable thermal anisotropy measurement device designed for use at home
Primary outcome measures
- Correlation Between Study Device Flow Measurement and Subject-reported Headaches [Time frame: 30 days]
Eligibility criteria
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
- 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
- Prior enrollment in this study
- Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Rhaeos, Inc — Chicago
Identifiers
NCT: NCT06996600 · 2025-01