10 Participants NeededMy employer runs this trial

Automated CSF Drainage for Hydrocephalus

(UPGRADE Trial)

PO
MD
Overseen ByMaria Denbow, CCRP
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Texas Southwestern Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the Intellidrop Automated CSF Drainage System, a device that manages hydrocephalus by automatically draining a small amount of fluid from around the brain. The goal is to make this process safer and more comfortable for patients while reducing nurses' workload. The trial seeks adults aged 60 years or older who have symptoms of normal pressure hydrocephalus, such as walking difficulties or memory problems, and are being assessed for potential shunt surgery.

As an unphased trial, this study offers patients the chance to contribute to innovative research that could enhance treatment options for hydrocephalus.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Intellidrop device is safe for automated CSF drainage?

Research has shown that the Intellidrop Automated CSF Drainage System is safe for use. The FDA has approved it, indicating it has passed safety checks for its intended purpose. The device safely and accurately drains cerebral spinal fluid (CSF), reducing nurses' workload and minimizing the risk of errors. While specific safety data from studies is not detailed, FDA approval suggests the device is generally well-tolerated by patients.12345

Why are researchers excited about this trial?

Researchers are excited about the Intellidrop Automated CSF Drainage System because it offers a new way to manage hydrocephalus. Unlike traditional shunt systems that require manual adjustments and can have complications like blockages, this system automatically adjusts the cerebrospinal fluid drainage. This has the potential to improve patient outcomes by providing more precise and consistent fluid management, reducing the risk of complications, and possibly decreasing the need for frequent surgical interventions.

What evidence suggests that the Intellidrop device is effective for hydrocephalus?

Research has shown that the Intellidrop Automated CSF Drainage System, an FDA-approved device, safely manages cerebrospinal fluid (CSF) drainage. The system monitors brain pressure and automatically adjusts fluid drainage, reducing errors. By automating the process, the device aims to enhance patient comfort and mobility. It has improved workflow and reduced the workload for nurses, particularly in ICU settings. While these features highlight the system's effectiveness, this trial will specifically evaluate its performance without directly comparing it to other treatments or methods.12346

Who Is on the Research Team?

DO

DaiWai Olson, PhD, RN, CCRN, FNCS

Principal Investigator

University of Texas

Are You a Good Fit for This Trial?

This trial is for adults aged 60 or older who are suspected of having normal pressure hydrocephalus and are in the hospital to see if they might benefit from a shunt by undergoing an external lumbar drain procedure.

Inclusion Criteria

I am 60 or older with suspected iNPH and am being admitted for an LDT to assess shunt benefit.

Exclusion Criteria

Pregnant patients
Patients who are currently incarcerated
I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Intellidrop Automated CSF Drainage System

3 months
Daily monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 months

What Are the Treatments Tested in This Trial?

Interventions

  • Intellidrop Automated CSF Drainage System

Trial Overview

The study is testing the Intellidrop Automated CSF Drainage System, which safely drains small amounts of spinal fluid while monitoring pressure. The goal is to make drainage safer, reduce nurse workload, and improve patient comfort during evaluation.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Experimental - Intellidrop Automated CSF Drainage SystemExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials
1,102
Recruited
1,077,000+

Citations

Study Details | NCT07494812 | Examining the Feasibility of ...

The Intellidrop evaluates feasibility, workflow efficiency, and safety by observing system performance and patient responses without comparison to a control ...

FDA Clears Automated Cerebrospinal Fluid Drainage and ...

The device integrates proprietary hardware and software to provide continuous brain pressure measurement and closed-loop, gravity-driven ...

3.

brainspacemed.com

brainspacemed.com/

BrainSpace

The Intellidrop is FDA cleared to provide external drainage of cerebrospinal fluid(CSF) and/or monitoring of CSF drainage and intracranial pressure (ICP) ...

Top Hydrocephalus Clinical Trials | Power

Automated CSF Drainage for Hydrocephalus. Dallas, Texas. The intellidrop device is an FDA-approved system that automates safe, small volume of cerebral spinal ...

Intellidrop Automated CSF Drainage System in NPH (Normal ...

It is designed to improve workflow efficiency, enhance patient mobility, and evaluate the device;s feasibility, performance and safety during the lumbar drain.

December 10, 2025 BrainSpace, Inc. Caitlin Morse CEO ...

The Intellidrop system is indicated for use to provide external drainage of cerebrospinal fluid. (CSF) and/or monitoring of CSF drainage and ...