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NCT07494812NARecruiting

Examining the Feasibility of Using Pressure Gradient Regulated Automated Cerebral Spinal Fluid Drainage During External Lumbar Drain Trials

University of Texas Southwestern Medical Center

Start Date

5/14/2026

Completion Date

10/31/2026

Summary

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

Detailed Description

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.

Eligibility Criteria

Age Range: 60 years to 99 years

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.

Interventions

DEVICE

Intellidrop Automated CSF Drainage System

DEVICE

Intellidrop Automated CSF Drainage System

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Conditions

NPH (Normal Pressure Hydrocephalus)

Locations

UT Southwestern Medical Center

Dallas, Texas 75390

United States