STIMULUS research group, Vrije Universiteit Brussel, Brussel, Belgium
Department of Neurosurgery, Universitair Ziekenhuis Brussel, Brussel, Belgium.
BMJ Open. 2024 Nov 9;14(11):e083610. doi: 10.1136/bmjopen-2023-083610.
Differential target multiplexed spinal cord stimulation (DTM SCS) is a new stimulation paradigm for chronic pain management with the aim of modulating glial cells and neurons in order to rebalance their interactions. Animal studies revealed positive effects of this type of stimulation; however, studies in humans are still scarce, pointing towards the need for an evaluation of the effectiveness and safety of DTM SCS in clinical settings. Furthermore, the differential target multiplexed (DTM) algorithm consists of a combination of several programmes, which will presumably consume more energy from the spinal cord stimulation (SCS) battery. Therefore, the objective of DETECT is to investigate the feasibility, effectiveness and safety of DTM SCS in patients with Persistent Spinal Pain Syndrome Type II through a longitudinal cohort study.
DETECT is a prospective multicentre cohort study (n≥250) with a follow-up until 12 months after receiving DTM SCS. The study initiated in October 2021 and is currently still recruiting patients. Self-reporting outcome variables were evaluated at baseline (before SCS) and at 1, 6 and 12 months of DTM SCS. The primary effectiveness endpoint is overall pain intensity, measured with the visual analogue scale. Secondary effectiveness outcome measures are back pain intensity, leg pain intensity, disability, health-related quality of life, pain medication use, functional disability, clinical holistic responder status, self-management, impression of change, work status, pain catastrophising, symptoms of central sensitisation, anxiety, depression and healthcare utilisation. Time spent in different body postures and SCS stimulation parameters will be read out from the pulse generator. The prevalence of technical issues, recharge frequency, (serious) adverse events and the proportion of successful DTM trials will be collected as well. Longitudinal mixed models will be calculated to evaluate the effectiveness of DTM SCS over time.
The study protocol was approved by the central Ethics Committee of the Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel (B.U.N.1432021000563) and the Ethics Committees of each participating centre. Research findings will be disseminated to key stakeholders through peer-reviewed publications in scientific journals and presentations to clinical audiences.
NCT05068011.
差异靶向多路脊髓刺激（DTM SCS）是一种用于慢性疼痛管理的新型刺激模式，其目的是调节神经胶质细胞和神经元，以重新平衡它们之间的相互作用。动物研究显示出这种类型的刺激的积极效果；然而，人类研究仍然很少，这表明需要在临床环境中评估 DTM SCS 的有效性和安全性。此外，差异靶向多路（DTM）算法由多个程序的组合组成，这可能会消耗脊髓刺激（SCS）电池更多的能量。因此，DETECT 的目的是通过一项纵向队列研究，调查 DTM SCS 在持续性脊柱疼痛综合征 II 型患者中的可行性、有效性和安全性。
DETECT 是一项前瞻性多中心队列研究（n≥250），随访至接受 DTM SCS 后 12 个月。该研究于 2021 年 10 月启动，目前仍在招募患者。在基线（SCS 前）和 DTM SCS 后 1、6 和 12 个月时，评估自我报告的结局变量。主要有效性终点是整体疼痛强度，用视觉模拟量表测量。次要有效性结局指标是背痛强度、腿痛强度、残疾、健康相关生活质量、疼痛药物使用、功能障碍、临床整体反应状态、自我管理、变化印象、工作状态、疼痛灾难化、中枢敏化症状、焦虑、抑郁和医疗保健利用。将从脉冲发生器中读取不同体位和 SCS 刺激参数所花费的时间。还将收集技术问题的发生率、充电频率、（严重）不良事件和成功 DTM 试验的比例。将计算纵向混合模型，以评估 DTM SCS 随时间的有效性。
该研究方案已获得布鲁塞尔大学医院、布鲁塞尔自由大学（B.U.N.1432021000563）中央伦理委员会和每个参与中心伦理委员会的批准。研究结果将通过在科学期刊上发表同行评议的文章和向临床听众介绍，向主要利益攸关方传播。
NCT05068011。
