Department of Neurosurgery, Nagoya University Graduate School of Medicine, 65 Tsurumai-Cho, Showa-Ku, Nagoya, Aichi, 466-8550, Japan.
Department of Advanced Medicine, Nagoya University Graduate School of Medicine, 65 Tsurumai-Cho, Showa-Ku, Nagoya, Aichi, 466-8550, Japan.
Trials. 2023 Sep 23;24(1):604. doi: 10.1186/s13063-023-07637-x.
Spinal cord stimulation (SCS) is one of the neuromodulation therapies for chronic neuropathic pain. The conventional paresthesia-based SCS involves the application of tonic stimulation that induces a sense of paresthesia. Recently, new SCS stimulation patterns without paresthesia have been developed. Differential target multiplexed (DTM) stimulation and fast-acting subperception therapy (FAST) stimulation are the latest paresthesia-free SCS patterns.
A single-center, open-label, crossover, randomized clinical trial to investigate the superiority of SCS using the latest new stimulation patterns over conventional tonic stimulation for neuropathic pain is planned. This study consists of two steps: SCS trial (first step) and SCS system implantation (second step). In the SCS trial, participants will be randomly assigned to 4 groups receiving stimulation, including tonic, DTM, and FAST. Each stimulation will then be performed for 2 days, and a visual analog scale (VAS) for pain will be evaluated before and after each stimulation pattern. A stimulation-off period for 1 day is set between each stimulation pattern to wash out the residual previous stimulation effects. Pain improvement is defined as more than 33% reduction in the pain VAS. The primary analysis will compare pain improvement between the new stimulation patterns and the conventional tonic stimulation pattern in the SCS trial. The secondary outcomes will be evaluated as follows: (1) the relationships between causative disease and improvement rate by each stimulation pattern; (2) comparison of pain improvement between the DTM and FAST stimulation patterns in all cases and by causative disease; (3) changes in assessment items preoperatively to 24 months after the implantation; (4) preoperative factors associated with long-term effects defined as continuing for more than 12 months; and (5) adverse events related to this study 3 months after the implantation.
This study aims to clarify the effectiveness of the latest new stimulation patterns compared to the conventional tonic stimulation. In addition, which stimulation pattern is most effective for which kind of causative disease will be clarified.
Japan Registry of Clinical Trials (jRCT) 1,042,220,094. Registered on 21 November 2022, and last modified on 6 January 2023. jRCT is an approved member of the Primary Registry Network of WHO ICTRP.
脊髓刺激 (SCS) 是治疗慢性神经性疼痛的神经调节疗法之一。传统的基于感觉异常的 SCS 涉及到应用强直刺激，这种刺激会引起感觉异常。最近，已经开发出了没有感觉异常的新型 SCS 刺激模式。差分靶向复用 (DTM) 刺激和快速感知治疗 (FAST) 刺激是最新的无感觉异常的 SCS 模式。
计划进行一项单中心、开放标签、交叉、随机临床试验，以研究使用最新的新型刺激模式进行 SCS 的优越性，优于传统的强直刺激治疗神经性疼痛。这项研究由两个步骤组成：SCS 试验（第一步）和 SCS 系统植入（第二步）。在 SCS 试验中，参与者将被随机分配到接受刺激的 4 个组，包括强直、DTM 和 FAST。然后，每个刺激将进行 2 天，在每个刺激模式前后评估疼痛的视觉模拟量表 (VAS)。在每个刺激模式之间设置 1 天的刺激关闭期，以冲洗掉先前刺激的残留效应。疼痛改善定义为疼痛 VAS 降低超过 33%。主要分析将比较新刺激模式与 SCS 试验中传统强直刺激模式的疼痛改善。次要结果将如下评估：（1）通过每种刺激模式，病因疾病与改善率之间的关系；（2）在所有病例和病因疾病中，DTM 和 FAST 刺激模式之间的疼痛改善比较；（3）植入术后 24 个月内术前评估项目的变化；（4）与长期效果相关的术前因素定义为持续超过 12 个月；以及（5）植入术后 3 个月与本研究相关的不良事件。
本研究旨在阐明与传统强直刺激相比，最新新型刺激模式的有效性。此外，还将阐明哪种刺激模式对哪种病因疾病最有效。
日本临床试验注册中心（jRCT）1,042,220,094。于 2022 年 11 月 21 日注册，并于 2023 年 1 月 6 日进行了修改。jRCT 是世界卫生组织 ICTRP 主要登记处网络的认可成员。
