Assessment of CSF Shunt Flow and Headaches With a Thermal Measurement Device

NCT06996600 | Recruiting FDA Device

• 1 other identifier: 2025-01
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hydrocephalus

Outcome Measures

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)

  30 days

Study Arms (1)

CSF Shunted Patients with Chronic Headaches

EXPERIMENTAL

hydrocephalus patients with an existing ventriculoperitoneal (VP) shunt who experience chronic headaches, defined as ≥15 headache episodes/month for ≥3 months

Device: wireless thermal anisotropy measurement device

Interventions

wireless thermal anisotropy measurement device DEVICE

Wireless wearable thermal anisotropy measurement device designed for use at home

CSF Shunted Patients with Chronic Headaches

Eligibility Criteria

• Age: 6 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rhaeos, Inc.: lead

Study Sites (1)

Rhaeos, Inc

Chicago, Illinois, 60642, United States

RECRUITING

MeSH Terms

Conditions

Hydrocephalus

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Anna Somera

CONTACT

855-814-3569; clinical@rhaeos.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: May 30, 2025
• Study Start: May 2, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)