MINT: Modulating Inflammation in Neuro-Trauma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Number of Adverse Events
研究概览
简要总结
MINT is a single-site, prospective, randomized, double-blind, sham-controlled pilot trial evaluating the safety and feasibility of transcutaneous auricular vagus nerve stimulation (taVNS) in patients with moderate to severe traumatic brain injury (GCS 3-12). Participants will be randomized to receive either active taVNS or sham stimulation using the same device. The primary objective is to assess the safety and feasibility of taVNS implementation in the acute TBI setting. Secondary objectives include exploratory measurement of serum inflammatory and neuronal injury biomarkers and assessment of functional outcome using the Extended Glasgow Outcome Scale at hospital discharge.
详细描述
MINT is a pilot randomized controlled trial designed to establish the safety and feasibility of taVNS in acute moderate to severe TBI prior to a larger efficacy trial. Sixteen patients with GCS 3-12 admitted to University Hospital, San Antonio will be randomized 1:1 to active taVNS or sham stimulation. Patients entering the University Hospital trauma bay who are diagnosed with traumatic brain injury (TBI) will be prescreened according to inclusion/exclusion criteria for entrance into this study. Participants will be randomized to receive either treatment with active taVNS or sham treatment. A blood draw will be performed prior to initiating auricular vagus nerve stimulation.
Patients will undergo standard of care treatment according to attending physicians, and the investigators will continue taVNS treatment during the course of the patients' admissions. The control group will undergo sham stimulation using the same device placed at the same location. Both active and sham stimulations will be administered under the supervision of study staff, and both patients and treating clinicians will be blinded to group assignment. Patients will be stimulated twice daily with periodic blood draws for up to 7 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind design with participants (when cognitively able), outcome assessors, clinical teams, and laboratory personnel blinded to treatment assignment. Unblinded study personnel will program devices but not assess outcomes.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years old
- •Glasgow Coma Scale (GCS) Score 3-12
- •Expected Intensive Care Unit (ICU) stay > 48 hours
- •Presenting with acute Traumatic Brain Injury (TBI) within 24 hours
排除标准
- •Any electrical implanted device
- •Immunomodulatory medication
- •Human Immune Deficiency Virus (HIV) patients
- •Autoimmune disease
- •Known cancer immunotherapy
- •Past medical history of symptomatic bradycardia
- •Penetrating brain injury
- •Clinical team assessment of prognosis and imminent risk of death such as Decision to withdraw life-sustaining measures
- •Current incarceration
- •Trauma/Laceration to the left ear
结局指标
主要结局
Number of Adverse Events
时间窗: Baseline to study end (approximately 7 days)
Frequency of adverse events related to tsVNS will be assessed through systematic monitoring
Feasibility of recruitment
时间窗: Baseline
Proportion of eligible patients who consent to participate in the study, protocol adherence, and device tolerability.
次要结局
- Change in Interleuken-6 (IL-6) Biomarker Level(Baseline to study end (approximately 7 days))
- Change in Glial fibrillary acidic protein (GFAP) levels(Baseline to study end (approximately 7 days))
- Extended Glasgow Outcome Scale(Baseline to study end (approximately 7 days))
研究者
Michael McGinity
Associate Professor
The University of Texas Health Science Center at San Antonio