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New treatment option for Traumatic Brain Injury
Official title Vagus Nerve Stimulation in Patients in Comatose State
ClinicalTrials.gov ID: NCT07719595
What this study is testing
- What it's testing
- Some patients with severe traumatic brain injury cannot respond at the bedside, yet about 1 in 4 may be aware but unable to show it - a hidden state called cognitive motor dissociation. This study tests a gentle, non-invasive treatment delivered through clips on the left ear that stimulates two nerves at once: the vagus nerve at the inner ear (taVNS) and the trigeminal nerve at the outer ear (taTNS).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years
- Coma, vegetative state/unresponsive wakefulness syndrome (VS/UWS), or minimally conscious state (MCS) as determined by baseline CRS-R
- Acute traumatic brain injury with documented intracranial pathology on neuroimaging
- Admission to the Neurology or Neurosurgical ICU
- Legally authorized representative (LAR) available and willing to consent, including the Stimulation Addendum Consent Form
You likely can't join if
- Implanted cardiac pacemaker, vagus nerve stimulator, or other active implanted device
- Known cardiac arrhythmia (e.g., 2nd-/3rd-degree AV block, atrial fibrillation with uncontrolled rate)
- Active seizures not controlled by current antiepileptic regimen
- Skin breakdown, infection, or anatomical abnormality of the left ear precluding electrode placement
- Pregnancy
- Hemodynamic instability requiring vasopressor escalation at the time of enrollment
The study team makes the final eligibility decision.
Where it's taking place
- Stony Brook, New York, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stony Brook, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.