Neurosurgery, University of Minnesota Medical School Twin Cities, Minneapolis, Minnesota, USA
Division of Neurosurgery, Hennepin County Medical Center, Minneapolis, Minnesota, USA.
BMJ Open. 2022 Jul 18;12(7):e059126. doi: 10.1136/bmjopen-2021-059126.
Spinal cord injury (SCI) leads to significant changes in morbidity, mortality and quality of life (QOL). Currently, there are no effective therapies to restore function after chronic SCI. Preliminary studies have indicated that epidural spinal cord stimulation (eSCS) is a promising therapy to improve motor control and autonomic function for patients with chronic SCI. The aim of this study is to assess the effects of tonic eSCS after chronic SCI on quantitative outcomes of volitional movement and cardiovascular function. Our secondary objective is to optimise spinal cord stimulation parameters for volitional movement.
The Epidural Stimulation After Neurologic Damage (ESTAND) trial is a phase II single-site self-controlled trial of epidural stimulation with the goal of restoring volitional movement and autonomic function after motor complete SCI. Participants undergo epidural stimulator implantation and are followed up over 15 months while completing at-home, mobile application-based movement testing. The primary outcome measure integrates quantity of volitional movement and similarity to normal controls using the volitional response index (VRI) and the modified Brain Motor Control Assessment. The mobile application is a custom-designed platform to support participant response and a kinematic task to optimise the settings for each participant. The application optimises stimulation settings by evaluating the parameter space using movement data collected from the tablet application and accelerometers. A subgroup of participants with cardiovascular dysautonomia are included for optimisation of blood pressure stabilisation. Indirect effects of stimulation on cardiovascular function, pain, sexual function, bowel/bladder, QOL and psychiatric measures are analysed to assess generalisability of this targeted intervention.
This study has been approved after full review by the Minneapolis Medical Research Foundation Institutional Review Board and by the Minneapolis VA Health Care System. This project has received Food and Drug Administration investigational device exemption approval. Trial results will be disseminated through peer-reviewed publications, conference presentations and seminars.
NCT03026816.
脊髓损伤 (SCI) 会导致发病率、死亡率和生活质量 (QOL) 发生重大变化。目前，尚无有效的治疗方法来恢复慢性 SCI 后的功能。初步研究表明，硬膜外脊髓刺激 (eSCS) 是一种有前途的治疗方法，可以改善慢性 SCI 患者的运动控制和自主功能。本研究旨在评估慢性 SCI 后强直 eSCS 对自主运动的定量结果和心血管功能的影响。我们的次要目标是优化用于自主运动的脊髓刺激参数。
神经损伤后硬膜外刺激 (ESTAND) 试验是一项单站点自身对照的硬膜外刺激 II 期试验，旨在恢复运动完全性 SCI 后的自主运动和自主功能。参与者接受硬膜外刺激器植入，并在 15 个月的随访期间在家中使用基于移动应用的运动测试。主要结果测量综合了使用自主反应指数 (VRI) 和改良脑运动控制评估的自主运动的数量和与正常对照组的相似性。移动应用程序是一个定制的平台，用于支持参与者的响应和运动任务，以优化每个参与者的设置。该应用程序通过使用从平板电脑应用程序和加速度计收集的运动数据评估参数空间，来优化刺激设置。包括患有心血管自主神经功能障碍的参与者亚组，以优化血压稳定化。通过分析刺激对心血管功能、疼痛、性功能、肠/膀胱、QOL 和精神措施的间接影响，评估这种针对性干预的普遍性。
该研究在明尼苏达医学研究基金会机构审查委员会和明尼苏达州退伍军人事务部医疗保健系统的全面审查后获得批准。该项目已获得美国食品和药物管理局的研究性设备豁免批准。试验结果将通过同行评议的出版物、会议演讲和研讨会进行传播。
NCT03026816。
