Vagus Nerve Stimulation in Patients in Comatose State
2026년 7월 17일 업데이트: 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.
연구 개요
상태
모병
상세 설명
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.
연구 유형
중재적
등록 (추정된)
10
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Sima Mofakham, PhD
- 전화번호: 631-444-1278
- 이메일: sima.mofakham@stonybrookmedicine.edu
연구 장소
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New York
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Stony Brook, New York, 미국, 11794
- 모병
- Stony Brook University Hospital
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연락하다:
- Sima Mofakham, PhD
- 전화번호: 631-444-1278
- 이메일: sima.mofakham@stonybrookmedicine.edu
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Dual-site auricular stimulation (taVNS + taTNS)
Experimental: Dual-site auricular stimulation (taVNS + taTNS).
All enrolled participants receive active vagal and trigeminal auricular stimulation.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Coma Recovery Scale-Revised (CRS-R) Total Score
기간: Baseline to Day 7, or baseline to Day 28 for participants with extended treatment
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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.
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Baseline to Day 7, or baseline to Day 28 for participants with extended treatment
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Change in SeeMe-Detected Stimulus-Evoked Voluntary Motor Responses
기간: Baseline to Day 7, or baseline to Day 28 for participants with extended treatment
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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.
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Baseline to Day 7, or baseline to Day 28 for participants with extended treatment
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of Participants With Device- or Stimulation-Related Adverse Events
기간: Baseline to Day 7, or baseline to Day 28 for participants with extended treatment
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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.
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Baseline to Day 7, or baseline to Day 28 for participants with extended treatment
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 6월 26일
기본 완료 (추정된)
2029년 12월 1일
연구 완료 (추정된)
2029년 12월 1일
연구 등록 날짜
최초 제출
2026년 6월 26일
QC 기준을 충족하는 최초 제출
2026년 7월 17일
처음 게시됨 (실제)
2026년 7월 22일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 22일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 17일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- IRB2019-00199 MOD061
- R61MH138612 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
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 공유 기간
Beginning 12 months after publication of the primary results and ending 5 years following publication.
IPD 공유 액세스 기준
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 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ANALYTIC_CODE
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
예
미국에서 제조되어 미국에서 수출되는 제품
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .