Emory Neurologic Physical Therapy Residency Program (A.B., R.P.), Doctor of Physical Therapy Program, Department of Rehabilitation Medicine (J.B.), Emory University, Atlanta, Georgia; Division of Physical Therapy, Department of Rehabilitation Medicine (S.L.W.), Emory University, School of Medicine, Atlanta, Georgia; Departments of Cell Biology and Medicine (S.L.W.), Woodruff School of Nursing, Emory University, Atlanta, Georgia; Atlanta VA Center for Visual and Neurocognitive Rehabilitation (S.L.W.), Decatur, Georgia.
J Neurol Phys Ther. 2024 Oct 1;48(4):217-223. doi: 10.1097/NPT.0000000000000488. Epub 2024 Sep 17.
Implantable vagus nerve stimulation (VNS) paired with volitional upper extremity rehabilitation can improve impairment and function among moderately to severely impaired, chronic stroke survivors. This study is a retrospective analysis of the in-clinic rehabilitation phase of the blinded, placebo-controlled, randomized pivotal VNS-REHAB trial to determine whether dosing parameters during in-clinic paired VNS therapy were associated with responder status and whether covariates might impact that determination.
Data were limited to 53 participants in the active VNS group who had received VNS implants prior to undergoing 6 weeks of in-clinic rehabilitation paired with VNS. Tasks were standardized across all participants. Dosing parameters included number of stimulations and task time. The primary outcome was the Fugl-Meyer Upper Extremity Assessment (FMA-UE), evaluated at the end of 6 weeks (Post-1). Participants were classified a priori as responders based on an improvement of ≥6 points on the FMA-UE from baseline to Post-1.
Dosing parameters were not associated with FMA-UE responder status at the end of 6 weeks. Covariates including age, gender, paretic hand, baseline severity, and chronicity of stroke were also not significant associations of response.
While responders to VNS could be defined, therapy dosing and participant attributes did not provide greater specification for association of responder status. Limitations of this study include small sample size and non-linearity of the FMA-UE. Future studies will include reassessing responder categorization using more linear scales and examining stroke lesion characteristics to determine whether these measures are more sensitive to dosing parameters.
for more insights from the authors (see the Video, Supplemental Digital Content 1, available at: http://www.w3.org/1999/xlink ).
植入式迷走神经刺激(VNS)与自主上肢康复相结合,可改善中重度慢性卒中幸存者的损伤和功能。本研究对盲法、安慰剂对照、随机主要 VNS-REHAB 试验的门诊康复阶段进行回顾性分析,以确定门诊配对 VNS 治疗期间的剂量参数是否与应答者状态相关,以及是否有协变量可能影响这一确定。
数据仅限于 53 名接受过 VNS 植入的活性 VNS 组参与者,他们在接受 6 周门诊康复治疗的同时接受 VNS。所有参与者的任务均标准化。剂量参数包括刺激次数和任务时间。主要结果是 Fugl-Meyer 上肢评估(FMA-UE),在 6 周后(Post-1)进行评估。根据 FMA-UE 从基线到 Post-1 的改善≥6 分,参与者被预先分为应答者。
在 6 周时,剂量参数与 FMA-UE 应答者状态无关。协变量包括年龄、性别、瘫痪手、基线严重程度和卒中慢性,与反应也无显著关联。
虽然可以定义 VNS 的应答者,但治疗剂量和参与者特征并不能更好地确定应答者状态的相关性。本研究的局限性包括样本量小和 FMA-UE 的非线性。未来的研究将包括使用更线性的量表重新评估应答者分类,并检查卒中病变特征,以确定这些措施是否对剂量参数更敏感。
欲了解更多作者观点(请观看视频,补充数字内容 1,可在 http://www.w3.org/1999/xlink 获得)。