Vagus Nerve Stimulation in Patients in Comatose State

Официальное название

Dual-Site Transcutaneous Auricular Nerve Stimulation (taVNS + taTNS) for Disorders of Consciousness After Traumatic Brain Injury: A Pilot Efficacy Study

Обзор

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.

Подробное описание

This prospective, single-center, open-label, single-arm pilot study enrolls a subcohort of comatose TBI patients from the parent SeeMe study (NCT07560631) whose legally authorized representative consents to a stimulation addendum. Dual-site transcutaneous auricular nerve stimulation is delivered to the left ear: the vagal site (cymba conchae) targets the auricular branch of the vagus nerve, and the trigeminal site (outer ear) targets the auriculotemporal branch - each with distinct, optimized parameters. Mechanistically, vagal afferents project to the nucleus tractus solitarius and the ascending reticular activating system to promote arousal, while trigeminal afferents project via the spinal trigeminal nucleus to thalamus and cortex to enhance thalamocortical connectivity; the dual-site paradigm aims to drive the cortico-striatal-thalamic-cortical loop from two convergent directions. Baseline assessment captures CRS-R, GCS, vital signs, NCS-R, heart-rate variability, and EEG. Daily one-hour sessions include pre/post vitals, NCS-R-guided titration, continuous telemetry, ear-site inspection, and daily CRS-R. In parallel, the SeeMe computer-vision platform quantifies stimulus-evoked facial and hand movements. The course runs 7 consecutive days, extendable to 28 days. Findings will inform a future sham-controlled randomized trial and closed-loop integration with SeeMe.

Вмешательства

• Устройство 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. Cour

Первичные конечные точки

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

Вторичные конечные точки (1)

• Number of Participants With Device- or Stimulation-Related Adverse Events [Срок оценки: Baseline to Day 7, or baseline to Day 28 for participants with extended treatment]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Stony Brook University Hospital — Stony Brook

Идентификаторы

NCT: NCT07719595 · IRB2019-00199 MOD061 · R61MH138612

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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