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

NCT07494812 | Not Yet Recruiting DMC

• 1 other identifier: STU20260216
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

NPH (Normal Pressure Hydrocephalus)

Keywords

UPGRADE; Cerebrospinal fluid buildup (CSF buildup)

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  from enrollment to the end of three months or until 10 subjects have been enrolled

Study Arms (1)

Experimental - Intellidrop Automated CSF Drainage System

EXPERIMENTAL

Device

Device: Intellidrop Automated CSF Drainage System

Interventions

Intellidrop Automated CSF Drainage System DEVICE

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.

Experimental - Intellidrop Automated CSF Drainage System

Eligibility Criteria

• Age: 60 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients who are under 18 years of age, pregnant, or are currently incarcerated will be excluded from participating in this study.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Related Publications (1)

• Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.

  PMID: 28851459 BACKGROUND

MeSH Terms

Conditions

Hydrocephalus, Normal Pressure

Condition Hierarchy (Ancestors)

Hydrocephalus; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• DaiWai Olson, PhD, RN, CCRN, FNCS

  University of Texas

  STUDY DIRECTOR

Central Study Contacts

Padraig O'Suilleabhain, M.D.

CONTACT

214-648-2943; padraig.osuilleabhain@utsouthwestern.edu

Maria Denbow, CCRP

CONTACT

214-648-6719; maria.denbow@utsouthwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: This study uses a single-group interventional design in which all participants undergo lumbar drain trials using the Intellidrop device (BrainSpace) automated CSF drainage system. The Intellidrop evaluates feasibility, workflow efficiency, and safety by observing system performance and patient responses without comparison to a control group. The lumbar drain will be connected to the Intellidrop device and set to drain 5 mL per hour. The entire period will be four days, the drain will be removed on the 4th day.

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 27, 2026
• Study Start: April 21, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share