An interventional study of Intellidrop Automated CSF Drainage System and Intellidrop Automated CSF Drainage System in NPH (Normal Pressure Hydrocephalus), sponsored by University of Texas Southwestern Medical Center. Recruiting at 1 site in United States. Open to participants aged 60 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-06-02.
Sponsored by University of Texas Southwestern Medical Center · Not applicable, Interventional, and Device feasibility
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
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.
71 studies on the registry are indexed under Hydrocephalus, Normal Pressure; 17 are open to participants now.
This study's planned enrollment of 10 is below the median of 50 across 37 interventional studies indexed under Hydrocephalus, Normal Pressure.
Browse Hydrocephalus, Normal Pressure studies →University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.
Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device
Device: Intellidrop Automated CSF Drainage System
Participants 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.
Participants will undergo lumbar drainage using the Intellidrop automated cerebrospinal fluid drainage system that provides continuous intracranial pressure monitoring and automated control of CSF removal. It is programmed to withdraw small frequent volumes of CSF within predefined safety limits reducing the need for manual stopcock adjustments and minimizing human error. It is designed to improve workflow efficiency, enhance patient mobility, and evaluate the device;s feasibility, performance and safety during the lumbar drain.
Feasibility
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.
Time frame: FIM scores will be obtained on a daily basis during month 3 - 5.
Acceptability
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.
Time frame: from enrollment to the end of three months or until 10 subjects have been enrolled
Plan to share: No
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Hydrocephalus, Normal Pressure→
University of Texas Southwestern Medical Center