Baig Sheharyar S, Mooney Cara, McKendrick Kirsty, Duffy Kate E M, Ali Ali N, Redgrave Jessica N, Herbert Esther, Waterhouse Simon, Su Li, Drummond Avril, Dawson Jesse, Dimairo Munyaradzi, Biggs Katie, Cooper Cindy, Majid Arshad
Sheffield Institute for Translational Neuroscience, The University of Sheffield, Sheffield, UK.
School of Medicine and Population Health, The University of Sheffield, Sheffield, UK.
BMJ Open. 2025 Mar 26;15(3):e092520. doi: 10.1136/bmjopen-2024-092520.
Arm weakness after stroke is one of the leading causes of adult-onset disability. Invasive vagus nerve stimulation (VNS) paired with rehabilitation has been shown to improve arm recovery in chronic stroke. Small studies of non-invasive or transcutaneous VNS (tVNS) suggest it is safe and tolerable. However, it is not known whether tVNS paired with rehabilitation is effective in promoting arm recovery in chronic stroke and what the mechanisms of action are.
TRICEPS is a UK multicentre, double-blinded, superiority, parallel-group, three-arm two-stage with an option to select promising arm(s) at 50% accrual, individually randomised, sham-controlled trial. Up to 243 participants will be randomised (1:1:1) using minimisation via a restricted, web-based centralised system. tVNS will be delivered by a movement-activated tVNS system (TVNS Technologies), which delivers stimulation during repetitive task practice. Rehabilitation will consist of repetitive task training for 1 hour a day, 5 days per week for 12 weeks. Participants will be adults with anterior circulation ischaemic stroke between 6 months and 10 years prior with moderate-severe arm weakness. The primary outcome measure will be the change in Upper Limb Fugl-Meyer total motor score at 91 days after the start of treatment. Secondary outcome measures include the Wolf Motor Function Test, the Modified Ashworth Scale to assess spasticity in the affected arm and the Stroke-Specific Quality of Life Scale. A mechanistic substudy including 40 participants will explore the mechanisms of active versus sham tVNS using multimodal MRI and serum inflammatory cytokine levels. Participant recruitment started on 30 November 2023.
The study has received ethical approval from the Cambridge Central Research Ethics Committee (REC reference: 22/NI/0134). Dissemination of results will be via publications in scientific journals, meetings, written reports and articles in stakeholder publications.
ISRCTN20221867.
中风后手臂无力是成人残疾的主要原因之一。侵入性迷走神经刺激（VNS）与康复相结合已被证明可改善慢性中风患者的手臂恢复情况。关于非侵入性或经皮VNS（tVNS）的小型研究表明其安全且可耐受。然而，尚不清楚tVNS与康复相结合是否能有效促进慢性中风患者的手臂恢复以及其作用机制是什么。
TRICEPS是一项英国多中心、双盲、优效性、平行组、三臂两阶段试验，在入组50%时可选择有前景的组别，采用个体随机、假对照试验。通过基于网络的受限集中系统采用最小化法将最多243名参与者随机分为三组（1:1:1）。tVNS将由运动激活的tVNS系统（TVNS Technologies）提供，该系统在重复性任务练习期间进行刺激。康复将包括每天1小时、每周5天、共12周的重复性任务训练。参与者为6个月至10年前发生前循环缺血性中风且伴有中度至重度手臂无力的成年人。主要结局指标为治疗开始后91天时上肢Fugl-Meyer总运动评分的变化。次要结局指标包括Wolf运动功能测试、用于评估患侧手臂痉挛的改良Ashworth量表以及中风特异性生活质量量表。一项包括40名参与者的机制性亚研究将使用多模态MRI和血清炎症细胞因子水平探索主动tVNS与假tVNS的作用机制。参与者招募于2023年11月30日开始。
该研究已获得剑桥中央研究伦理委员会的伦理批准（REC编号：22/NI/0134）。研究结果将通过在科学期刊上发表、会议、书面报告以及利益相关者出版物中的文章进行传播。
ISRCTN20221867。
