Vagus Nerve Stimulation in Patients in Comatose State
2026年7月17日 更新者：Sima Mofakham
Dual-Site Transcutaneous Auricular Nerve Stimulation (taVNS + taTNS) for Disorders of Consciousness After Traumatic Brain Injury: A Pilot Efficacy Study
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.
研究概览
地位
招聘中
详细说明
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.
研究类型
介入性
注册 (估计的)
10
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Sima Mofakham, PhD
- 电话号码：631-444-1278
- 邮箱：sima.mofakham@stonybrookmedicine.edu
学习地点
-
-
New York
-
Stony Brook、New York、美国、11794
- 招聘中
- Stony Brook University Hospital
-
接触：
- Sima Mofakham, PhD
- 电话号码：631-444-1278
- 邮箱：sima.mofakham@stonybrookmedicine.edu
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Dual-site auricular stimulation (taVNS + taTNS)
Experimental: Dual-site auricular stimulation (taVNS + taTNS).
All enrolled participants receive active vagal and trigeminal auricular stimulation.
|
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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Coma Recovery Scale-Revised (CRS-R) Total Score
大体时间：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.
|
Baseline to Day 7, or baseline to Day 28 for participants with extended treatment
|
|
Change in SeeMe-Detected Stimulus-Evoked Voluntary Motor Responses
大体时间：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.
|
Baseline to Day 7, or baseline to Day 28 for participants with extended treatment
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants With Device- or Stimulation-Related Adverse Events
大体时间：Baseline to Day 7, or baseline to Day 28 for participants with extended treatment
|
Adverse events attributed to auricular stimulation will be recorded and graded using CTCAE v5.0, including ear-site skin reactions, bradycardia or other arrhythmia, oxygen desaturation, and hemodynamic instability.
Events requiring NCS-R-guided dose reduction or meeting prespecified stopping criteria will be reported.
|
Baseline to Day 7, or baseline to Day 28 for participants with extended treatment
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年6月26日
初级完成 (估计的)
2029年12月1日
研究完成 (估计的)
2029年12月1日
研究注册日期
首次提交
2026年6月26日
首先提交符合 QC 标准的
2026年7月17日
首次发布 (实际的)
2026年7月22日
研究记录更新
最后更新发布 (实际的)
2026年7月22日
上次提交的符合 QC 标准的更新
2026年7月17日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- IRB2019-00199 MOD061
- R61MH138612 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
De-identified individual participant data underlying published results will be shared, including CRS-R scores, SeeMe-derived movement metrics, stimulation parameters, and safety data.
Data will be available following publication of the primary results.
Requests will be reviewed by the study team and require a data use agreement and confirmation of appropriate IRB or ethics approval.
Raw facial video will not be shared due to the inherent re-identifiability of facial imagery; derived quantitative movement features will be shared instead.
IPD 共享时间框架
Beginning 12 months after publication of the primary results and ending 5 years following publication.
IPD 共享访问标准
Access will be granted to qualified investigators whose proposed use has been approved by the study team.
Requestors must submit a methodologically sound research proposal and a signed data use agreement, and must provide documentation of IRB or equivalent ethics approval for the proposed analysis.
Approved requestors will receive de-identified individual participant data, including CRS-R scores, SeeMe-derived quantitative movement metrics, stimulation parameters, and safety data, together with the study protocol, statistical analysis plan, and blank informed consent form.
Raw facial video will not be released due to the inherent re-identifiability of facial imagery.
Requests should be directed to the principal investigator at sima.mofakham@stonybrookmedicine.edu.
IPD 共享支持信息类型
- 研究方案
- 树液
- 分析代码
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
是的
在美国制造并从美国出口的产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.