Non-traumatic Hemispheric Brain LesionsNCT04745884

A Study to Detect Progression of Mass Effect From Unilateral Brain Lesions

A study testing Non-invasive bilateral monitoring of ICP waveform in people with Non-traumatic Hemispheric Brain Lesions, run by Mayo Clinic at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this research is to gather information on the safety and effectiveness of the Brain4Care device for measuring intracranial pressure without invasive procedures. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-traumatic Hemispheric Brain Lesions
What is being tested?: Non-invasive bilateral monitoring of ICP waveform
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteUnited States
Study dates: 4 Feb 2021to 2 Dec 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult patients with non-traumatic hemispheric brain lesions deemed at risk for progression of mass effect and possible subfalcine and/or uncal herniation.
Patients admitted the Neuroscience ICU for serial neurological monitoring.
Patients whose care is not expected to include immediate surgical decompression.

Who cannot join

Patients under the age of 18.
Patients who are unable to provide consent due to neurologic deficit and does not have a surrogate decision maker available to provide consent.
Known or suspected Pregnancy
Adults with cranial defects or that have undergone craniectomy

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic in Rochester
Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Early Non-invasive Detection of Progression of Mass Effect From Unilateral Brain Lesions

The purpose of this research is to gather information on the safety and effectiveness of the Brain4Care device for measuring intracranial pressure without invasive procedures.

Conditions: Non-traumatic Hemispheric Brain Lesions
Being tested: Non-invasive bilateral monitoring of ICP waveform

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Non-invasive bilateral monitoring of ICP waveformDevice
Brain4care non-invasive bilateral monitoring of ICP waveform

Study groups in NCT04745884
Study group	Role	What they receive
Monitoring	Experimental	Imaging guided by monitoring results Receives: Device: Non-invasive bilateral monitoring of ICP waveform

What is being measured

The primary outcome is the main question the study is designed to answer.

Functional Outcome
Functional outcome was assessed using the Modified Rankin Scale (mRS) which assesses functional outcomes in patients recovering from strokes. It consists of a 7-point ordinal scale ranging from 0 to 6 where 0=no symptoms and 6=dead with higher scores indicating a worse functional outcome.
Measured: 3 months

Secondary outcomes (1)

Imaging Utilization
Number of imaging scans
Measured: within ICU admission

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Feb 20212 Dec 2024

First posted9 Feb 2021
Study start4 Feb 2021
Primary completion2 Dec 2024
Study completion2 Dec 2024

Why it stopped: Device sensitive issues

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Non-traumatic Hemispheric Brain LesionsStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe 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: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04745884
Sponsor's protocol ID: 20-009516
Status last verified: Dec 2025
First submitted: 4 Feb 2021
Last updated: 6 Feb 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Study at a glance

From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Early Non-invasive Detection of Progression of Mass Effect From Unilateral Brain Lesions
ClinicalTrials.gov ID: NCT04745884
Acronym / sponsor ID: 20-009516
Conditions: Non-traumatic Hemispheric Brain Lesions
Study type: Interventional
Recruitment status: TerminatedReason stopped: Device sensitive issues
Enrolment: 6 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Study start: 4 Feb 2021 (actual)
Primary completion: 2 Dec 2024 (actual)
Study completion: 2 Dec 2024 (actual)
First posted: 9 Feb 2021 (actual)
Results: Posted 6 Feb 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this research is to gather information on the safety and effectiveness of the Brain4Care device for measuring intracranial pressure without invasive procedures.

Study design

Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Monitoring	Experimental	Device: Non-invasive bilateral monitoring of ICP waveformImaging guided by monitoring results

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Adult patients with non-traumatic hemispheric brain lesions deemed at risk for progression of mass effect and possible subfalcine and/or uncal herniation.
Patients admitted the Neuroscience ICU for serial neurological monitoring.
Patients whose care is not expected to include immediate surgical decompression.

Key exclusion criteria (4 listed)

Patients under the age of 18.
Patients who are unable to provide consent due to neurologic deficit and does not have a surrogate decision maker available to provide consent.
Known or suspected Pregnancy
Adults with cranial defects or that have undergone craniectomy

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
Non-invasive bilateral monitoring of ICP waveformBrain4care non-invasive bilateral monitoring of ICP waveform	Device	Monitoring

Primary outcome

Functional Outcome
Time frame: 3 months
Functional outcome was assessed using the Modified Rankin Scale (mRS) which assesses functional outcomes in patients recovering from strokes. It consists of a 7-point ordinal scale ranging from 0 to 6 where 0=no symptoms and 6=dead with higher scores indicating a worse functional outcome.

1 secondary outcome

Imaging Utilization
Time frame: within ICU admission

Results and safety

Results posted to the registry on 6 Feb 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Monitoring	6	3

Primary outcome: Functional Outcome

Time frame: 3 months. Mean (Inter-Quartile Range). Unit: score on a scale

Measure	Monitoring n = 5
Value	3 (2 to 4)

Population analysed: 1 patient was unable to be reached for follow up

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected from the time of informed consent through study completion, approximately 3 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Monitoring	0 of 6 (0%)	0 of 6 (0%)	2 of 6

Limitations and caveats (from the sponsor): The study was terminated early as there were issues with the sensitive of the device.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Mayo Clinic Clinical TrialsLink provided by the sponsor.

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. This study is not recruiting at the moment.

Alejandro Rabinstein, MD principal investigator

Mayo Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Non-invasive bilateral monitoring of ICP waveform in people with Non-traumatic Hemispheric Brain Lesions, run by Mayo Clinic 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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 6 Feb 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?

Yes. Results are posted in the registry (first posted 6 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional Outcome (time frame: 3 months). 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 NCT04745884.

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 6 Feb 2026.