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Helmet device tracks brain pressure in COVID-19 patients

NCT ID NCT04861402

Knowledge-focused Sponsor: Federal University of São Paulo Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested a non-invasive helmet-like device to monitor brain pressure and detect tiny strokes in 60 hospitalized COVID-19 patients. The goal was to understand how COVID-19 affects the brain without using needles or surgery. Participants wore the device for one hour daily for up to seven days. The results could help doctors spot neurological problems early in COVID-19 patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could provide a safe, non-invasive way to monitor brain health in COVID-19 patients and help detect early signs of stroke or other neurological issues.
What could go wrong
This is a small, completed observational study with only 60 participants. It does not test a treatment, so it cannot directly improve outcomes. The findings may not apply to all COVID-19 patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

60 people

The number who actually took part.

Started

Apr 2020

Finished

Dec 2021

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

This is a multicenter longitudinal study of 4 centers in Brazil: Hospital of São Paulo (Federal University of São Paulo), Benemérita Portuguese Charity Association, São Paulo-SP, ESHO Hospital Services Company AS, São Paulo, SP and Federal University of São Carlos, São Carlos-SP, from June to December of 2020. This will follow Helsinki recommendations for human protocols. This study was approved by Federal University of São Paulo's Human Research Ethics Committee (process number 4,050,985). The patients who completed the inclusion criteria (table 1) will be invited to participate, and they will receive an Informed Consent Form (ICF). At least 60 subjects will be included, and they will be equally divided into 4 groups.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: For COVID-19 group: * Men and women (not pregnant) Older than 18 years old Diagnosis of COVID-19 confirmed by Reverse Transcription Polymerase Chain Reaction (RT-PCR) Subjects intubated or non-intubated Time between admission and study inclusion ≤ 72h For intubated group time between IUC admission and study inclusion ≤ 72h Time between onset symptoms and study inclusion ≤ 14 days No neurological acute disease No cutaneous injury in the head to impossibility the ICP monitoring ICF signed by the participant or his/her legal representative\* No cutaneous injury in the head to impossibility the monitoring with the transcranial doppler helmet Patients who have not been submitted to decompressive craniectomy previously. Subjects intubated or non-intubated For intubated group time between IUC admission and study inclusion ≤ 72h Time between admission and study inclusion ≤ 72h Time between onset symptoms and study inclusion ≤14 days No neurological acute disease For Controls Group: Men and women (not pregnant) Older than 18 years old No cutaneous injury in the head to impossibility the ICP monitoring • For intubated group: ICF signed by the participant or his/her legal representative\* Intubated patients for others causes than COVID-19 or neurological diseases IUC admission and study inclusion ≤ 72h No symptoms of COVID-19 on the last 15 days • For healthy group: No previous neurological disease No chronic disease as Diabetes Mellitus Type 2, Chronic Obstructive Pulmonary Disease (COPD), Heart Failure, hypertension or Chronic Kidney Disease (CKD) No cutaneous injury in the head to impossibility the monitoring with the transcranial doppler helmet Patients who have not been submitted to decompressive craniectomy previously. IUC admission and study inclusion ≤ 72h No neurological diseases Exclusion Criteria: * It will be excluded those who asked to stop their participation, and those with problems in acquiring ICP data.

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Conditions

The condition(s) this trial relates to.

COVID-19 intracranial hypertension

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Intracranial pressure

Contacts and locations

Locations

  • Hospital São Paulo

    São Paulo, São Paulo, 05409-003, Brazil

More trials for these conditions

Other studies related to the condition(s) this trial covers.