Vagus Nerve Stimulation in Patients in Comatose State

Part of paid clinical trials in Stony Brook, New York.

Sponsor
Sima Mofakham
Study ID
NCT07719595
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dual-Site Transcutaneous Auricular Nerve Stimulation (taVNS + taTNS) — DEVICE
    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.

Study Details

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.

Key Dates

First listed
Jul 22, 2026
Start date
Jun 26, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stony Brook University HospitalStony BrookNew York11794
Sima Mofakham, PhD
[email protected]
631-444-1278

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By research site
Stony Brook University Hospital· Stony Brook, NY

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