Spieker Eira Lotta, Hoffmann Marie, Otto Carolin, Ruprecht Klemens, Harms Lutz, Schauer Thomas, Salchow-Hömmen Christina, Wenger Nikolaus
Department of Neurology, Charité-Universitätsmedizin Berlin, Berlin, Germany.
Control Systems Group, Technische Universität Berlin, Berlin, Germany.
Front Neurol. 2025 Aug 21;16:1618519. doi: 10.3389/fneur.2025.1618519. eCollection 2025.
Gait deficits and leg spasticity are frequent symptoms in Primary and Secondary Progressive Multiple Sclerosis (PPMS and SPMS). Transcutaneous spinal cord stimulation (tSCS) may alleviate these symptoms through the reduction of spinal hyperexcitability. We conducted a single-center, randomized, sham-controlled clinical crossover study (German Clinical Trials Register: DRKS00023357, https://www.drks.de/search/en) in patients with PPMS and SPMS to assess the therapy effects of tSCS on spasticity and gait in the post stimulation period.
Twenty participants were included in the study to receive tSCS and sham interventions on two separate study days in randomized order. Patients and examiners were blinded to the sequence allocation, which was performed using a quasi-randomized procedure to ensure balanced group sizes. The tSCS intervention consisted of biphasic pulses applied for 30 min at 50 Hz to lumbar spinal segments. Assessments were carried out before and immediately after each intervention. The primary outcome was defined as the Modified Ashworth Scale (MAS) sum score for bilateral leg spasticity. Secondary outcomes included unilateral MAS sum scores and clinical gait assessments. We used inertial sensors to monitor gait kinematics and EMG to record Posterior-Root-Muscle-Reflexes (PRM-reflex) in leg muscles.
Following the exclusion of two dropouts and two participants who did not reach the target intensity, sixteen participants, evenly distributed across the two intervention sequences, were included in the analysis. In comparison to sham, tSCS had a small effect on bilateral MAS sum score (effect size = -0.25, p = 0.12, CI: -5.67-0.63, for Generalized Equation Estimation), which didn't reach significance. More patients showed an improvement in stimulation condition (10 out of 16 patients) than in sham condition (7 out of 16 patients). We observed negligible effects of tSCS on clinical gait tests, kinematic parameters and PRM-reflex recruitment.
Our results showed that tSCS had a small but no significant effect on spasticity. A reduction of spasticity did not immediately translate into an improvement of gait performance.
https://www.drks.de/search/en, identifier: DRKS00023357.
步态缺陷和腿部痉挛是原发进展型和继发进展型多发性硬化症（PPMS和SPMS）的常见症状。经皮脊髓刺激（tSCS）可能通过降低脊髓兴奋性过高来缓解这些症状。我们对PPMS和SPMS患者进行了一项单中心、随机、假对照临床交叉研究（德国临床试验注册：DRKS00023357，https://www.drks.de/search/en），以评估tSCS在刺激后阶段对痉挛和步态的治疗效果。
20名参与者纳入研究，在两个不同的研究日以随机顺序接受tSCS和假干预。患者和检查者对序列分配不知情，序列分配采用准随机程序进行，以确保两组人数均衡。tSCS干预包括以50Hz向腰段脊髓施加双相脉冲30分钟。在每次干预前和干预后立即进行评估。主要结局定义为双侧腿部痉挛的改良Ashworth量表（MAS）总分。次要结局包括单侧MAS总分和临床步态评估。我们使用惯性传感器监测步态运动学，并使用肌电图记录腿部肌肉的后根肌肉反射（PRM反射）。
排除两名退出者和两名未达到目标强度的参与者后，16名参与者纳入分析，他们在两个干预序列中分布均匀。与假干预相比，tSCS对双侧MAS总分有较小影响（效应量=-0.25，p=0.12，CI：-5.67-0.63，广义方程估计），未达到显著水平。与假干预组（16名患者中的7名）相比，更多患者在刺激组（16名患者中的10名）有改善。我们观察到tSCS对临床步态测试、运动学参数和PRM反射募集的影响可忽略不计。
我们的结果表明，tSCS对痉挛有较小但不显著的影响。痉挛的减轻并未立即转化为步态表现的改善。
