What side effects are associated with this type of intervention?

Common treatments for hydrocephalus, such as the surgical implantation of shunts, often have side effects including infection, shunt malfunction, and the need for multiple surgeries due to shunt failure. Noninvasive monitoring devices like FlowSense aim to mitigate these issues by providing a less invasive method to assess shunt function and CSF flow, potentially reducing the frequency of hospital visits and imaging requirements.

What prior FDA approvals exist?

The primary FDA-approved treatment for hydrocephalus has traditionally been the surgical implantation of shunts to divert excess cerebrospinal fluid (CSF) from the brain to another part of the body where it can be absorbed. While the FlowSense device represents a novel, noninvasive approach to monitoring CSF flow in shunts, there is limited information on similar FDA-approved noninvasive technologies specifically for hydrocephalus. Most current treatments focus on invasive surgical methods rather than noninvasive monitoring solutions.

What other types of research exist?

As of 2024, promising alternatives to FlowSense for hydrocephalus patients include: 1) Implantable shunt systems with integrated wireless monitoring capabilities, which provide real-time data on CSF flow and pressure. 2) Advanced MRI and CT imaging techniques that offer noninvasive, detailed assessments of CSF dynamics. 3) Smart shunt systems equipped with sensors that can adjust CSF drainage rates automatically based on real-time monitoring. These technologies aim to reduce the need for frequent hospital visits and improve overall patient management.

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FlowSense Monitoring for Hydrocephalus (RHAEOS Trial)

N/A

Recruiting

Led By Samuel McClugage, MD

Research Sponsored by Baylor College of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing FlowSense, a small, wireless sensor that helps monitor fluid flow in patients with hydrocephalus. It aims to reduce hospital visits and surgeries by providing an easy way to check if the treatment is working. The sensor sends data to a mobile app, making it simple for doctors to keep track of the patient's condition.

Who is the study for?

This trial is for patients who have hydrocephalus and currently have one or more external ventricular drains (EVDs) in place. It's not suitable for those without any EVDs.

What is being tested?

The trial is testing FlowSense, a wireless, noninvasive device that monitors cerebrospinal fluid flow through shunts to detect blockages or malfunctions without the need for complex equipment.

What are the potential side effects?

Since FlowSense is noninvasive and similar to wearing a bandage on the neck, it likely has minimal side effects related to skin contact such as potential irritation or discomfort at the site of application.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Exploratory outcome

Secondary study objectives

Suitability

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Phase BExperimental Treatment1 Intervention

Exploratory study to generate initial data on the correlation between FlowSense flow rate measurements (FlowSense Flow Rate) and: A) EVD drainage data, quantified via video recording; B) intracranial pressure (ICP) measurements

Group II: Phase A:Active Control1 Intervention

Establish suitability of digital video recording system for quantifying CSF drainage into an EVD drainage system.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The primary treatment for hydrocephalus involves the surgical implantation of shunts, which redirect excess cerebrospinal fluid (CSF) from the brain to another part of the body, such as the abdominal cavity, where it can be absorbed. This helps to relieve the pressure on the brain caused by the fluid buildup. Monitoring the function of these shunts is crucial because they can fail, leading to potentially life-threatening complications. Technologies like FlowSense, a wireless, noninvasive thermal flow sensor, are significant as they allow for real-time monitoring of CSF flow without the need for invasive procedures or frequent imaging, thereby improving patient safety and reducing hospital visits.