NPH (Normal Pressure Hydrocephalus)UPGRADENCT07494812
Examining the Feasibility of Using Pressure Gradient Regulated Automated Cerebral Spinal Fluid Drainage During External Lumbar Drain Trials
A study testing Intellidrop Automated CSF Drainage System in people with NPH (Normal Pressure Hydrocephalus), run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 60 to 99 years
- Conditions the study is for
- NPH (Normal Pressure Hydrocephalus)
- What is being tested?
- Intellidrop Automated CSF Drainage System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2026to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients who are under 18 years of age, pregnant, or are currently incarcerated will be excluded from participating in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UT Southwestern Medical Center
Dallas, Texas, 75390
Maria Denbow, 281-605-0356, Maria.Denbow@UTSouthwestern.edu
Padraig O'Suilleabhain, M.D.
About this study
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
Read the 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.
- Conditions
- NPH (Normal Pressure Hydrocephalus)
- Being tested
- Intellidrop Automated CSF Drainage System
- Keywords
- UPGRADE, Cerebrospinal fluid buildup (CSF buildup)
- Medical subject headings
- Hydrocephalus, Normal Pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intellidrop Automated CSF Drainage SystemDevice
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.
Intellidrop Automated CSF Drainage SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental - Intellidrop Automated CSF Drainage System | Experimental | Device Receives: Device: Intellidrop Automated CSF Drainage System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: from enrollment to the end of three months or until 10 subjects have been enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start14 May 2026
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NPH (Normal Pressure Hydrocephalus)Studies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Padraig O'Suilleabhain, University of Texas Southwestern Medical Center
- Investigators
- DaiWai Olson, PhD, RN, CCRN, FNCS, Study director, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07494812
- Sponsor's protocol ID
- STU20260216
- Acronym
- UPGRADE
- Status last verified
- May 2026
- First submitted
- 9 Mar 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28851459
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Feasibility of Using Pressure Gradient Regulated Automated Cerebral Spinal Fluid Drainage During External Lumbar Drain Trials
- ClinicalTrials.gov ID
- NCT07494812
- Acronym / sponsor ID
- UPGRADE / STU20260216
- Conditions
- NPH (Normal Pressure Hydrocephalus)
- Keywords
- UPGRADE, Cerebrospinal fluid buildup (CSF buildup)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 14 May 2026 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental - Intellidrop Automated CSF Drainage System | Experimental | Device: Intellidrop Automated CSF Drainage SystemDevice |
Who may qualify
- Ages
- 60 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients who are under 18 years of age, pregnant, or are currently incarcerated will be excluded from participating in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intellidrop Automated CSF Drainage SystemParticipants 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. | Device | Experimental - Intellidrop Automated CSF Drainage System |
| Intellidrop Automated CSF Drainage SystemParticipants 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. | Device | Experimental - Intellidrop Automated CSF Drainage System |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Background: PubMed 28851459Weiner 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
DaiWai Olson, PhD, RN, CCRN, FNCS study director
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intellidrop Automated CSF Drainage System in people with NPH (Normal Pressure Hydrocephalus), run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Padraig O'Suilleabhain, M.D. (214-648-2943, padraig.osuilleabhain@utsouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: FIM scores will be obtained on a daily basis during month 3 - 5.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07494812, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.