Ament Michael, Leonard Emily, Staats Peter S, Ingram Norianne T
Cherry Creek Neurology, Denver, CO, United States.
Vagus Nerve Society, Atlantic Beach, FL, United States.
Front Neurol. 2025 Aug 26;16:1642034. doi: 10.3389/fneur.2025.1642034. eCollection 2025.
Traumatic brain injury (TBI) remains a major public health challenge, with mild TBI (mTBI) frequently resulting in persistent cognitive, affective, and somatic symptoms. Non-invasive vagus nerve stimulation (nVNS) has demonstrated potential in reducing neuroinflammation and promoting recovery in preclinical TBI models. This retrospective, observational study assessed the impact of adjunctive nVNS on postconcussive symptoms in routine clinical practice.
We conducted a single-center observational cohort study consisting of 102 patients with mTBI who received adjunctive nVNS as part of standard care. Symptom severity was measured using the Neurobehavioral Symptom Inventory (NSI) at baseline and approximately 112 days post-treatment initiation. The primary outcome was the change in NSI symptom scores. Secondary analyses explored associations between baseline symptom severity, treatment response, and secondary clinical measures. Safety data were collected throughout the study period.
In this patient cohort, 16 of 22 NSI symptom domains showed significant improvement after three months of treatment with adjunctive nVNS. The most notable reductions were observed for post-traumatic headache (-0.79 ± 1.19; = 1.97 × 10), difficulty concentrating (-0.59 ± 1.25; = 1.79 × 10), dizziness (-0.47 ± 1.14; = 7.11 × 10), and depression/sadness (-0.47 ± 1.12; = 9.09 × 10). Approximately onethird (34%) of patients met responder criteria (≥30% reduction) for at least half of the assessed symptoms, indicating broad and clinically meaningful symptom relief. The length of the interval between injury and treatment initiation did not significantly influence baseline symptom severity or the magnitude of improvement. No devicerelated adverse events were reported.
In a naturalistic clinical setting, adjunctive nVNS was associated with significant reductions in post-concussive symptom severity across cognitive, affective, somatic, and vestibular domains in patients with mTBI. These findings support the use of nVNS as a practical, safe, and effective intervention for persisting symptoms due to mTBI. Further prospective, controlled studies are warranted to validate these observations and elucidate underlying mechanisms.
创伤性脑损伤（TBI）仍然是一项重大的公共卫生挑战，轻度创伤性脑损伤（mTBI）常常导致持续的认知、情感和躯体症状。在临床前TBI模型中，非侵入性迷走神经刺激（nVNS）已显示出在减轻神经炎症和促进恢复方面的潜力。这项回顾性观察性研究评估了辅助性nVNS在常规临床实践中对脑震荡后症状的影响。
我们进行了一项单中心观察性队列研究，纳入了102例mTBI患者，他们接受了辅助性nVNS作为标准治疗的一部分。在基线和治疗开始后约112天，使用神经行为症状量表（NSI）测量症状严重程度。主要结局是NSI症状评分的变化。二次分析探讨了基线症状严重程度、治疗反应和次要临床指标之间的关联。在整个研究期间收集安全性数据。
在这个患者队列中，22个NSI症状领域中的16个在接受辅助性nVNS治疗三个月后显示出显著改善。创伤后头痛（-0.79±1.19；P = 1.97×10）、注意力不集中（-0.59±1.25；P = 1.79×10）、头晕（-0.47±1.14；P = 7.11×10）和抑郁/悲伤（-0.47±1.12；P = 9.09×10）的改善最为显著。约三分之一（34%）的患者至少一半的评估症状达到了反应标准（减轻≥30%），表明症状得到了广泛且具有临床意义的缓解。受伤与治疗开始之间的间隔时间长度并未显著影响基线症状严重程度或改善幅度。未报告与设备相关的不良事件。
在自然主义的临床环境中，辅助性nVNS与mTBI患者认知、情感、躯体和前庭领域的脑震荡后症状严重程度显著降低相关。这些发现支持将nVNS用作治疗mTBI所致持续症状的一种实用、安全且有效的干预措施。有必要进行进一步的前瞻性对照研究以验证这些观察结果并阐明潜在机制。
