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

NCT ID: NCT06996600

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-02
• Study Completion Date: 2025-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

CSF Shunted Patients with Chronic Headaches

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

Group Type: EXPERIMENTAL

wireless thermal anisotropy measurement device

Intervention Type: DEVICE

Wireless wearable thermal anisotropy measurement device designed for use at home

Interventions

wireless thermal anisotropy measurement device

Wireless wearable thermal anisotropy measurement device designed for use at home

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rhaeos, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rhaeos, Inc

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Anna Somera

Role: CONTACT

clinical@rhaeos.com

855-814-3569

Facility Contacts

Anna Somera

Role: primary

clinical@rhaeos.com

855-814-3569

Other Identifiers

2025-01

Identifier Type: -

Identifier Source: org_study_id