Assessment of CSF Shunt Flow and Headaches With a Thermal Measurement Device
ConditionHydrocephalus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-80
SponsorRhaeos, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
wireless thermal anisotropy measurement device
DeviceWireless wearable thermal anisotropy measurement device designed for use at home
Treatment groups
29 Participants
are divided into 1 treatment groupGroup A: CSF Shunted Patients with Chronic HeadachesExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Correlation Between Study Device Flow Measurement and Subject-reported Headaches
Exploratory analysis to determine the relationship between headaches (subject-reported headache and non-headache periods) and measured flow. Data will be analyzed using the Point-Biserial Correlation Coefficient between headaches periods (headache and non-headache periods) and thermal flow score (flow score derived from algorithm analysis of raw thermal data)
Time frame
30 daysSponsors and contacts
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Source ClinicalTrials.gov