Dual-Site Transcutaneous Auricular Nerve Stimulation (taVNS + taTNS) for Disorders of Consciousness After Traumatic Brain Injury: A Pilot Efficacy Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in Coma Recovery Scale-Revised (CRS-R) Total Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in Coma Recovery Scale-Revised (CRS-R) Total Score
时间窗: Baseline 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 Responses
时间窗: Baseline 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.
次要结局
- Number of Participants With Device- or Stimulation-Related Adverse Events(Baseline to Day 7, or baseline to Day 28 for participants with extended treatment)
研究者
Sima Mofakham
Associate Professor of Neurosurgery
Stony Brook University