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Vagus Nerve Stimulation for Comatose Patients with Traumatic Brain Injury

This study is exploring a gentle, non-invasive treatment for patients in a coma or with other disorders of consciousness due to severe traumatic brain injury. The treatment, called Dual-Site Transcutaneous Auricular Nerve Stimulation (taVNS + taTNS), uses ear-clip electrodes on the left ear to stimulate two nerves at once: the vagus nerve and the trigeminal nerve. Researchers believe stimulating these nerves may help promote arousal and improve brain connections. All 10 enrolled patients will receive this stimulation for one hour a day. The study will measure changes in their Coma Recovery Scale-Revised (CRS-R) scores and voluntary movements to see if the treatment helps them recover. This study is currently recruiting patients.

Study design
This is a small, single-center pilot study involving 10 participants. All participants will receive the Dual-Site Transcutaneous Auricular Nerve Stimulation (taVNS + taTNS) intervention.
What's involved
Participants will receive daily one-hour stimulation sessions. They will have continuous heart and oxygen monitoring, and their ear site will be inspected daily.
Compensation
Not stated in the trial record.
Follow-up
Participants will be assessed at baseline to Day 7, or baseline to Day 28 for those with extended treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07719595

Vagus Nerve Stimulation in Patients in Comatose State

Recruiting
NAAges 18+InterventionalTreatment
Sima Mofakham
~10 participants
Updated 2026-07-22 on ClinicalTrials.gov
What's tested:Dual-Site Transcutaneous Auricular Nerve Stimulation (taVNS + taTNS)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Coma Recovery Scale-Revised (CRS-R) Total Score
Measured over Baseline to Day 7, or baseline to Day 28 for participants with extended treatment
+1 more outcome measured

Conditions

Traumatic Brain Injury
Severe Traumatic Brain Injury
Disorders of Consciousness Due to Severe Brain Injury
Coma, Traumatic

Explore related trials

ComaMinimally conscious stateTraumatic EncephalopathyUnresponsive Wakefulness SyndromeVegetative State

Where it's being run

1 sites across 1 states
New York1

Who to contact

Sima Mofakham, PhD
[email protected]
631-444-1278
Email the study team

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Change in Coma Recovery Scale-Revised (CRS-R) Total ScoreBaseline to Day 7, or baseline to Day 28 for participants with extended treatment

    Change in level of consciousness will be assessed using the Coma Recovery Scale-Revised total score. The outcome will be reported as the within-participant change in total score from baseline to the end of treatment, as scored by a trained assessor. Scores range from 0 to 23, with higher scores indicating better neurobehavioral function and greater recovery of consciousness.

  • Change in SeeMe-Detected Stimulus-Evoked Voluntary Motor ResponsesBaseline to Day 7, or baseline to Day 28 for participants with extended treatment

    Change in command-evoked voluntary motor responses will be assessed using the SeeMe automated camera-based detection system. The outcome will be reported as the within-participant change in the percentage of command trials with SeeMe-positive responses from baseline to the end of treatment. Scores range from 0% to 100%, with higher percentages indicating more frequent command-evoked voluntary motor responses. A SeeMe-positive response is defined as a Kolmogorov-Smirnov statistic greater than 0.1 and pixel displacement greater than 400, detected reliably in at least 3 of 10 command trials. SeeMe scoring will be automated and performed blinded to stimulation timing.