Using an automated CSF drainage device to help people with suspected iNPH
Official title: Examining the Feasibility of Using Pressure Gradient Regulated Automated Cerebral Spinal Fluid Drainage During External Lumbar Drain Trials
Run by University of Texas Southwestern Medical Center · NCT07494812 · Data updated 2026-11-12
This study tests whether the Intellidrop automated CSF drainage system can safely manage small fluid removals in older adults with suspected iNPH who are being evaluated for shunt therapy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 60 Years to 99 Years |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Status | Recruiting |
| Started | May 14, 2026 |
| Main results expected | October 31, 2026 |
| Study ends | October 31, 2026 |
| Registry record updated | June 2, 2026 |
| Trial ID | NCT07494812 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 60 years or older with suspected iNPH admitted for evaluation for shunt placement.
✕Probably not a fit
Patients who do not experience reliable CSF drainage within the target pressure range or who have contraindications to shunt evaluation may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The trial examines an FDA-approved automated CSF drainage device designed to remove small volumes of fluid under continuous pressure monitoring to reduce nursing workload and human error. It targets adults 60 and older with suspected iNPH admitted for evaluating shunt placement. The device allows programmable, periodic drainage within a safe pressure range and includes safeguards on total fluid removed over time. By enabling mobility and reducing the need for frequent manual adjustments, the study seeks to see if patient comfort and care efficiency improve.
Why it matters
Potential benefit: If successful, patients may experience safer, more comfortable CSF management with greater mobility and less nursing burden.
How similar studies have gone: Prior studies of automated CSF drainage systems have shown potential to reduce nursing workload and improve consistency of drainage, with mixed results depending on patient factors.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
UT Southwestern Medical Center
Dallas, Texas, United States Recruiting
Study contacts
- Study coordinator: Padraig O'Suilleabhain, M.D.
- Email: padraig.osuilleabhain@utsouthwestern.edu
- Phone: 214-648-2943
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.