Ear zaps might wake up coma patients?
NCT ID NCT04065386
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether a mild electrical stimulation on the ear (taVNS) could improve awareness in 44 patients with disorders of consciousness after a coma. For 5 days, patients received either real or sham stimulation. Researchers measured changes in behavior and brain activity. The goal was to see if this simple, non-invasive method could help jumpstart recovery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- transcutaneous auricular vagal nerve stimulation (taVNS) device
- What this could lead to
- If it works, this could offer a safe, non-invasive way to help some patients with severe brain injuries regain awareness.
- What could go wrong
- This is a small early trial with only 44 participants, so results may not apply to everyone. The effect may be modest or not last long.
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
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44 people
The number who actually took part.
- Started
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Feb 2022
- Finished
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Dec 2024
- Lead sponsor
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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
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18 to 99 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥ 18 years old * State of consciousness: unresponsive wakefulness syndrome (UWS) and minimally conscious state (MCS) as defined by CRS-R performed during the screening period. * Cerebral damage of known etiology * Time since injury between 7 and 90 days * Intact skin at the ears * Consent given by the substitute decision maker Exclusion Criteria: * Anyone who is deemed medically unsuitable for this study as determined by a physician involved with the study (e.g. severe rythmic heart condition) * Previous history of neurological disorders * Documented pregnancy * Active implant (i.e. pacemaker) * Profound sedation such as one caused by general anaesthetics (e.g., propofol) or a combination of central acting sedatives (e.g., benzodiazepines, opioids)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Centre Hospitalier Universitaire de Liège
Liège, Liège, 4000, Belgium
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Centre Neurologique William Lennox
Ottignies-Louvain-la-Neuve, Brabant Wallon, 1340, Belgium
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Brain wave test may unlock hidden awareness in coma patients