Faculty of Medicine, Suez Canal University, Ismailia, Egypt.
Faculty of Medicine, Cairo University, Cairo, Egypt.
Mult Scler Relat Disord. 2024 Mar;83:105471. doi: 10.1016/j.msard.2024.105471. Epub 2024 Jan 24.
Repetitive Transcranial Magnetic Stimulation (rTMS) is considered as a safe and non-invasive developing technique used as a therapeutic method for patients with Relapsing-Remitting Multiple Sclerosis (RRMS) who suffer from disturbances in gait and balance. The aim of our study is to evaluate the long-term effect of high frequency rTMS as a therapeutic option for truncal ataxia in RRMS patients and to assess its impact on the integrity of the white matter (WMI), measured in the form of anisotropy metrics using diffusion tensor imaging (DTI).
The study was conducted in two phases: phase I; a randomized, single-blind, sham-controlled phase and phase II was a 12 months longitudinal open-label prospective phase. Phase I of the trial involved the randomization of 43 patients with RRMS and truncal ataxia to either real (n = 20) or sham (n = 19) rTMS (2 participants from each treatment group were excluded from the study; one developed a relapse before treatment, 2 declined to participate, and one did not show up). Phase II involved providing 12 actual treatments cycles to all patients; each cycle length is 4 weeks, repeated four times on a trimonthly basis, forming a total of 48 sessions. DTI was used for assessment of the WMI. All patients performed DTI 3 times: Imaging sessions were conducted at the screening visit, at the end of phase I, and after the last session in phase II for the first, second and third sessions respectively. A figure-of-8-shape coil, employing rTMS protocol and located over the cerebellum, was used. rTMS protocol is formed of 20 trains formed of 50 stimuli with 20 s apart (5 Hz of 80 % of resting Motor Threshold "MT"). The Berg Balance Scale (BBS), Time up and go (TUG) test, and 10-m walk test (10MWT) were first evaluated at the start of each cycle and just after the final rTMS session.
The genuine rTMS group's 10MWT, TUG, and BBS showed substantial improvement (p < 0.01), which is continued to be improved throughout the study Timeline, with a significant difference observed following the final rTMS session (P< 0.001). A longitudinal increase in FA was observed in both the Cerebello-Thalamo-Cortical (CTC) and Cortico-Ponto-Cerebellar (CPC) bilateral, as indicated by means of Fractional Anisotropy (FA) measures (p < 0.05).
In ataxic RRMS patients, high frequency rTMS over the cerebellum has a long-term beneficial impact on both balance and WMI.
重复经颅磁刺激(rTMS)被认为是一种安全且非侵入性的发展技术,可用作缓解复发缓解型多发性硬化症(RRMS)患者步态和平衡障碍的治疗方法。本研究的目的是评估高频 rTMS 作为 RRMS 患者躯干性共济失调的治疗选择的长期效果,并评估其对脑白质完整性(WMI)的影响,通过弥散张量成像(DTI)以各向异性指标的形式进行测量。
研究分为两个阶段进行:第一阶段,是一项随机、单盲、假刺激对照试验;第二阶段是为期 12 个月的纵向开放性前瞻性试验。试验的第一阶段将 43 名 RRMS 伴躯干性共济失调的患者随机分为真刺激(n=20)或假刺激(n=19)rTMS 组(每组有 2 名患者被排除在研究之外,1 人在治疗前发生复发,2 人拒绝参与,1 人未出现)。第二阶段为所有患者提供 12 个实际治疗周期,每个周期长度为 4 周,每 3 个月重复 4 次,共 48 个疗程。DTI 用于评估 WMI。所有患者均进行了 3 次 DTI 检查:在筛查时、第一阶段结束时以及第二阶段的最后一次治疗后进行,分别用于第 1、2 和第 3 次检查。使用 8 字形线圈,采用 rTMS 方案,放置在小脑上方。rTMS 方案由 20 个由 50 个刺激组成的训练组成,间隔 20 秒(5Hz,80%的静息运动阈值“MT”)。在每个周期开始时和最后一次 rTMS 治疗后,首先评估 Berg 平衡量表(BBS)、起身和行走测试(TUG)和 10 米步行测试(10MWT)。
真正的 rTMS 组的 10MWT、TUG 和 BBS 均有明显改善(p<0.01),整个研究过程中持续改善,在最后一次 rTMS 治疗后有显著差异(P<0.001)。通过各向异性分数(FA)测量,双侧小脑-丘脑-皮质(CTC)和皮质-桥脑-小脑(CPC)的 FA 均有纵向增加(p<0.05)。
高频 rTMS 刺激小脑对 RRMS 患者的平衡和 WMI 有长期的有益影响。