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NCT Number: NCT06996600

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

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.

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Key information

Conditions

Hydrocephalus Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

6 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rhaeos, Inc

Chicago, Illinois, 60642, United States

Location status: Recruiting

Location contact

Anna Somera

CONTACT

[email protected]

855-814-3569

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

wireless thermal anisotropy measurement device

Device

Wireless wearable thermal anisotropy measurement device designed for use at home

Primary outcomes

  1. Correlation Between Study Device Flow Measurement and Subject-reported Headaches

    Time frame: 30 days

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Somera

CONTACT

[email protected]

855-814-3569

Sponsors and collaborators

Lead sponsor

Rhaeos, Inc.

Industry

Registry information

Official study title

Longitudinal Measurements of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device in People With Chronic Headaches

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 30, 2025
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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