Ear stimulation and robot therapy could wake up injured brains
NCT ID NCT06930716
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This pilot study tests whether combining a gentle nerve stimulator placed on the ear (taVNS) with robotic tilt-table therapy can safely help people with prolonged disorders of consciousness after severe brain injury. Fifteen participants will undergo 12 weeks of paired therapy, and researchers will measure changes in consciousness and function. The goal is to see if this combination is feasible and might boost 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 vagus nerve stimulation (taVNS) via ear device
- What this could lead to
- If it works, this could point toward a new rehabilitation approach to help people with long-term consciousness disorders regain function.
- What could go wrong
- This is a very small pilot study with only 15 participants, so results may not apply broadly. The treatment is experimental and may not lead to meaningful recovery.
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
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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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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- 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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22 years and older
- 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: * Patients with a diagnosis of pDOC (includes coma, VS/UWS, MCS, MCS +, MCS-) as defined as disorder of consciousness (DOC) greater than 6 weeks post onset * Patients deemed medically safe to participate in physical therapy (PT) as evaluated by the study physicians. Exclusion Criteria: * Patients who have emerged from MCS (CRS-R score 6 on Motor Function scale and/or 2 on Communication Scale). * Patients medically unsafe for participation in PT as indicated by one of the study physicians (including but not limited to those receiving intravenous sedation, those with integumentary breakdown or known pressure injuries, those with cardiovascular or cerebrovascular conditions precluding initiation of physical therapy \[ie uncontrolled intracranial pressure, severe symptomatic orthostatic hypotension, etc.). * Patients with DOC less than 6 weeks post onset will also be excluded. * Patients who do not meet technical requirements of the RTTM device will be excluded * weighing greater than 135 kg * length of legs below 75 cm or above 100 cm, * fixed contractures of lower extremity including hip, knee, ankle, or foot). * Does not have an identified care partner or legally authorized representative to consent to participation
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Genom att skicka in godkänner du våra Användarvillkor
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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Abilities Research Center, Icahn School of Medicine at Mount Sinai
RECRUITINGNew York, New York, 10029, United States
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Other studies related to the condition(s) this trial covers.
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