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Ear device could tame dangerous brain injury symptoms in kids

NCT ID NCT05343988

Symptom relief Sponsor: Medical College of Wisconsin 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a small device placed on the ear that sends gentle electrical pulses to calm overactive nerves in children with severe brain injury. The goal was to reduce sudden episodes of fast heart rate, high blood pressure, and other symptoms. The trial was very small and was stopped early, so we don't yet know if it works.

What this could mean

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

Active substance
Percutaneous Electrical Nerve Field Stimulation (PENFS) device
What this could lead to
If it works, this could offer a non-drug way to reduce dangerous symptoms like rapid heart rate and high blood pressure in children with severe brain injury.
What could go wrong
This was a very small pilot study (20 children) that was terminated early, so results are limited. The device is still experimental and may not work for all children.

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

20 people

The number who actually took part.

Started

Sep 2022

Finished

Nov 2025

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

2 to 17 years

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: * Children 2-17 years age with PSH due to ASBI * PSH severity score \> 6 (moderate severity) * Glasgow Coma Scale \< 15 Exclusion Criteria: * age \< 2 years (small ears thus less surface area to apply the leads) * ear deformity or severe dermatitis of ear lobes, * intractable seizures, heart block, patients with other implantable devices (cardiac pacemaker, vagal nerve stimulator, etc. * known pregnancy

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As listed by the trial registrant

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

Paroxysmal sympathetic hyperactivity

Contacts and locations

Locations

  • Children's Wisconsin

    Milwaukee, Wisconsin, 53226, United States

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