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Headband could spot deadly brain vessel spasms before they strike

NCT ID NCT04042571

Diagnosis Sponsor: University Hospital, Bordeaux 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Updated 1 time

Summary

This study tested whether a non-invasive device placed on the forehead (NIRS) can detect blood vessel spasms in the brain after a severe aneurysm rupture. Fifty patients were monitored continuously from day 4 to day 12 after their bleed. The goal was to see if this oxygen-measuring device could spot spasms earlier than standard tools like ultrasound or CT scans.

What this could mean

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

Active substance
Near-infrared spectroscopy (NIRS) monitoring device
What this could lead to
If successful, this could lead to earlier detection of vasospasm after brain hemorrhage, potentially preventing strokes and improving recovery.
What could go wrong
This is a small, early-stage study with only 50 participants. The device may not prove more accurate than current methods, and results may not apply to all 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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

50 people

The number who actually took part.

Started

Oct 2019

Finished

Dec 2022

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Men and women * Age ≥ 18 years * HSA of aneurysmal etiology less than 4 days before inclusion diagnosed by clinical presentation and emergency imaging * HSA "severe" defined according to the WFNS ≥ III * Intubated-ventilated patient or any other reason preventing a contributing neurological examination * Affiliate or beneficiary of a social security scheme * Free, informed and written consent signed by the representative Exclusion Criteria: * Age \<18 years * Significant vasospasm as soon as the detection was detected on the initial imaging * Possible Neurological Surveillance * Patient in limitation of active therapeutics or with high probability of soon limitation of active therapeutics * Intra-parenchymal frontal haematoma limiting the quality of measurement, diagnosed on imaging (Less than 25mm deep from the skin) * Patient in limitation of active therapeutics or with high probability of soon limitation of active therapeutics * Adhesive allergy to measuring patches * Patient under guardianship or safeguard of justice * Refusal of legal representative

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Conditions

The condition(s) this trial relates to.

subarachnoid hemorrhage

As listed by the trial registrant

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

Subarachnoid hemorrhage

Contacts and locations

Locations

  • CHU de Bordeaux

    Bordeaux, 33 076, France

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