UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Location status: Recruiting
Location contact
Maria Denbow
CONTACT
Padraig O'Suilleabhain, M.D.
PRINCIPAL_INVESTIGATOR
Recruiting
NCT Number: NCT07494812
Examining the Feasibility of Using Pressure Gradient Regulated Automated Cerebral Spinal Fluid Drainage During External Lumbar Drain Trials
The intellidrop device is an FDA-approved system that automates safe, small volume of cerebral spinal fluid drainage with continuous pressure monitoring, reducing nursing workload and human error while improving patient mobility and comfort
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
60 year–99 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
The intellidrop (BrainSpace, Inc) was approved by the Food and Drug Administration (FDA) for use in automating CSF drainage while providing continuous intracranial pressure (ICP) monitoring. Control parameters can be programmed for requent removal of small volumes of fluid contingent on pressure remaining in target range, and with guardrails on volume drained over a range of timespans. This reduces the frequency and duration of nursing attention to managing the stopcock every four hours as in the current design and may reduce risk of human error. The compact and mobile design allows for more freedom for patient mobility, and importantly for patient satisfaction, there is no longer a need for the patient to lay supine for one out of every four hours because substantial (20mls) volumes of CSF are no longer removed.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- All patients will be adults aged 60 years or older with suspected iNPH who are being admitted to the hospital for the purpose of an LDT specifically to evaluate for benefit from shunt placement.
Exclusion criteria
- Patients who are under 18 years of age, pregnant, or are currently incarcerated will be excluded from participating in this study.
Treatment and study plan
Intellidrop Automated CSF Drainage System
DeviceParticipants will undergo lumbar drainage using the Intellidrop automated cerebrospinal fluid drainage system that monitors intracranial or spinal pressure and manages external drainage of cerebrospinal fluid and other body fluids to a user selected pressure target or volume target. Its closed loop, gravity-based drainage ensures natural flow, while offering position-agnostic precision control to achieve an hourly target volume. It connects to the distal end of the lumbar catheter outside the body and replaces the drainage collection device and manual nursing effort.
Primary outcomes
-
Feasibility
Time frame: FIM scores will be obtained on a daily basis during month 3 - 5.
The feasibility of the intervention will be measured using the feasibility of the intervention measure (FIM). The FIM is a four item instrument that evaluates feasibility. The four scores are sumed and divided by 5 to provide a final score ranging from 0 to 1.0 with higher score indicating greater feasibility.
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Acceptability
Time frame: from enrollment to the end of three months or until 10 subjects have been enrolled
The acceptability of the intervention will be measured using the acceptablity of the intervention measure (AIM). The AIM is a four item instrument that evaluates feasibility. Similarly to the FIM score, the four scores are sumed and divided by 5 to provide a final score ranging from 0 to 1.0 with higher score indicating greater acceptablity.
Study contacts
Contact information is provided by the study sponsor or research team.
Maria Denbow, CCRP
CONTACT
Padraig O'Suilleabhain, M.D.
CONTACT
Sponsors and collaborators
Lead sponsor
University of Texas Southwestern Medical Center
Other
Registry information
Acronym: UPGRADE
Important dates
- Study start
- 2026
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Mar 27, 2026
- Registry last updated
- Jun 2, 2026
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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