Wireless monitoring of cerebrospinal fluid flow in hydrocephalus patients
The Correlation Between FlowSense Flow Rate Measurements and: EVD Drainage Data and Intracranial Pressure (ICP) Measurements
NA · Baylor College of Medicine · NCT05546996
This study is testing a new wireless device that helps monitor fluid flow in the brains of people with hydrocephalus to see if it can improve their care and reduce hospital visits.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 1 Year to 21 Years |
| Sex | All |
| Sponsor | Baylor College of Medicine (other) |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05546996 on ClinicalTrials.gov |
What this trial studies
This clinical trial focuses on the use of FlowSense, a noninvasive thermal flow sensor designed to monitor cerebrospinal fluid (CSF) flow in patients with hydrocephalus who have external ventricular drains (EVDs). The device is a soft, silicone patch that can be placed on the neck over the shunt, allowing for real-time data transmission to a mobile app. By providing a wireless and bedside assessment of shunt function, the study aims to reduce unnecessary imaging, hospital stays, and readmission rates associated with shunt failures. The trial seeks to improve patient outcomes by enabling better monitoring and management of this life-threatening condition.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with one or more existing external ventricular drains (EVDs).
Not a fit: Patients without external ventricular drains (EVDs) will not benefit from this study.
Why it matters
Potential benefit: If successful, this technology could significantly enhance the management of hydrocephalus, reducing emergency visits and improving patient quality of life.
How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, making this a novel application in the field.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with one or more existing external ventricular drains (EVDs). Exclusion Criteria: * Patients with no external ventricular drains (EVDs).
Where this trial is running
Houston, Texas
- Texas Children's Hospital — Houston, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Samuel McClugage, MD — Baylor College of Medicine
- Study coordinator: Samuel McClugage, MD
- Email: mcclugag@bcm.edu
- Phone: 8328223950
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hydrocephalus, EVD shunt