Recruiting

taVNS & taTNS

Sponsor:

Sima Mofakham

Code:

NCT07719595

Conditions

Traumatic Brain Injury

Severe Traumatic Brain Injury

Disorders of Consciousness Due to Severe Brain Injury

Coma, Traumatic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dual-Site Transcutaneous Auricular Nerve Stimulation (taVNS + taTNS)

Study Details

Brief summary:

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). Each nerve has separately been shown to help people with disorders of consciousness recover, but they have not been combined before. All enrolled patients receive the stimulation for one hour a day, with continuous heart and oxygen monitoring and a pain-protection check used to keep the dose safe. The study measures recovery two ways: the Coma Recovery Scale-Revised (CRS-R), scored by clinicians, and SeeMe, an automated camera system that detects tiny command-driven movements the eye cannot see.

Conditions

Traumatic Brain Injury

Severe Traumatic Brain Injury

Disorders of Consciousness Due to Severe Brain Injury

Coma, Traumatic

Study ID

NCT07719595

Start date

Jun 26, 2026

Status verified date

Jun, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dual-site auricular stimulation (taVNS + taTNS)

Experimental: Dual-site auricular stimulation (taVNS + taTNS). All enrolled participants receive active vagal and trigeminal auricular stimulation.

Interventions

Dual-Site Transcutaneous Auricular Nerve Stimulation (taVNS + taTNS)

DEVICE: Dual-Site Transcutaneous Auricular Nerve Stimulation (taVNS + taTNS). Delivered via ear-clip electrodes on the LEFT ear using the Sparrow Ascent / Sparrow Link tAN System (Spark Biomedical; FDA-cleared K230796), operated as an NSR investigational device. Vagal site (inner ear / cymba conchae): 15 Hz, 250 µs pulse width, 3 mA fixed, duty cycle 5 min on / 10 s off. Trigeminal site (outer ear): 100 Hz, 250 µs pulse width, 3 mA fixed, duty cycle 5 min on / 10 s off. Session: 1 hour/day. Course: 7 consecutive days, extendable to 28 days. Intensity titrated with the Nociception Coma Scale-Revised (NCS-R): step down 0.5 mA if NCS-R > 4/9, SpO2 ≤ 95%, or HR rises ≥ 20 bpm; continuous cardiac/hemodynamic monitoring with prespecified stopping rules.

Primary outcome measure

  • Change in Coma Recovery Scale-Revised (CRS-R) Total Score [ Time Frame: Baseline to Day 7, or baseline to Day 28 for participants with extended treatment ]
  • Change in SeeMe-Detected Stimulus-Evoked Voluntary Motor Responses [ Time Frame: Baseline to Day 7, or baseline to Day 28 for participants with extended treatment ]

Central Contacts and Locations

Central contacts

Sima Mofakham, PhD

631-444-1278sima.mofakham@stonybrookmedicine.edu

Locations

Stony Brook University Hospital

Recruiting

Stony Brook, New York, United States, 11794

Contacts

Sima Mofakham, PhD

631-444-1278sima.mofakham@stonybrookmedicine.edu

More Information

Sponsor

Sima Mofakham

Last update posted

Jul 22, 2026

Last verified

Jun, 2026

Keywords

  • taVNS
  • taTNS
  • transcutaneous auricular vagus nerve stimulation
  • trigeminal nerve stimulation
  • dual-site neuromodulation
  • coma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sima Mofakham on 2026-07-22.