■丘脑腹侧中核的单侧磁共振引导聚焦超声消融原发性震颤减少了1侧的震颤,但未经治疗的对侧或中线症状对一些患者仍然有限。历史上,双侧损伤产生了不可接受的风险,并被深部脑刺激所取代;单侧聚焦超声损伤的接受度越来越高,这引起了人们对双侧选择的兴趣.
■为了评估分期治疗的安全性和有效性,双侧聚焦超声丘脑切开术。
■这个前景,开放标签,多中心试验从2020年7月至2021年10月治疗特发性震颤患者,随访12个月,在美国7个学术医疗中心。在入选前至少9个月接受单侧聚焦超声丘脑切开术的62例患者中,排除11例,治疗51例。资格标准包括患者年龄(22岁及以上),药物难治性,震颤严重程度(震颤临床评定量表[CRST]A部分,姿势性或运动性震颤评分≥2),和功能性残疾(任何类别的CRSTC部分评分≥2)。
■与磁共振成像接口的聚焦超声系统允许热成像图与解剖结构的实时对准。在进行消融之前,亚阈值超声处理允许对疗效和脱靶效果进行目标询问。
■治疗后3个月,治疗方的震颤/运动评分(CRSTA和B部分)是主要结果指标,疗效和安全性的二级评估持续至12个月.
■平均(SD)人口年龄为73(13.9)岁,44名参与者(86.3%)为男性。在3个月时,平均(SD)震颤/运动评分从17.4(5.4;95%CI,15.9-18.9)提高到6.4(5.3;95%CI,4.9至7.9)(CRSTA和B部分评分改善66%;95%CI,59.8-72.2;P<.001)。平均(SD)姿势性震颤(从2.5[0.8];95%CI,2.3至2.7至0.6[0.9];95%CI,0.3至0.8;P<.001)和平均(SD)残疾评分(从10.3[4.7];95%CI,9.0-11.6至2.2[2.8];95%CI,1.4-2.9;P<.001)均有显著改善。12名参与者出现了轻度(研究定义的)共济失调,6名参与者在12个月时持续存在。不良事件(188中的159例[85%]轻度,188个[13%]中等比例中的25个,和1例严重尿路感染)报告最常见的包括麻木/刺痛(总共n=17;12个月时n=8),构音障碍(总共n=15;12个月时n=7),共济失调(总共n=12;12个月时n=6),不稳定/不平衡(总共n=10;12个月时n=0),和味觉障碍(总共n=7;12个月时n=3)。演讲难度,包括发声,衔接,和吞咽困难,通常是温和的(被评为无临床意义,没有参与者在所有3项措施中都有恶化)和短暂的。
■分期,双侧聚焦超声丘脑切开术可显著降低震颤严重程度和功能障碍评分.演讲的不良事件,吞咽,共济失调大多是轻度和短暂的。
■ClinicalTrials.gov标识符NCT04112381。
UNASSIGNED: Unilateral magnetic resonance-guided focused ultrasound ablation of ventralis intermedius nucleus of the thalamus for essential tremor reduces tremor on 1 side, but untreated contralateral or midline symptoms remain limiting for some patients. Historically, bilateral lesioning produced unacceptable risks and was supplanted by deep brain stimulation; increasing acceptance of unilateral focused ultrasound lesioning has led to interest in a bilateral option.
UNASSIGNED: To evaluate the safety and efficacy of staged, bilateral focused ultrasound thalamotomy.
UNASSIGNED: This prospective, open-label, multicenter trial treated patients with essential tremor from July 2020 to October 2021, with a 12-month follow-up, at 7 US academic medical centers. Of 62 enrolled patients who had undergone unilateral focused ultrasound thalamotomy at least 9 months prior to enrollment, 11 were excluded and 51 were treated. Eligibility criteria included patient age (22 years and older), medication refractory, tremor severity (Clinical Rating Scale for Tremor [CRST] part A score ≥2 for postural or kinetic tremor), and functional disability (CRST part C score ≥2 in any category).
UNASSIGNED: A focused ultrasound system interfaced with magnetic resonance imaging allowed real-time alignment of thermography maps with anatomy. Subthreshold sonications allowed target interrogation for efficacy and off-target effects before creating an ablation.
UNASSIGNED: Tremor/motor score (CRST parts A and B) at 3 months for the treated side after treatment was the primary outcome measure, and secondary assessments for efficacy and safety continued to 12 months.
UNASSIGNED: The mean (SD) population age was 73 (13.9) years, and 44 participants (86.3%) were male. The mean (SD) tremor/motor score improved from 17.4 (5.4; 95% CI, 15.9-18.9) to 6.4 (5.3; 95% CI, 4.9 to 7.9) at 3 months (66% improvement in CRST parts A and B scores; 95% CI, 59.8-72.2; P < .001). There was significant improvement in mean (SD) postural tremor (from 2.5 [0.8]; 95% CI, 2.3 to 2.7 to 0.6 [0.9]; 95% CI, 0.3 to 0.8; P < .001) and mean (SD) disability score (from 10.3 [4.7]; 95% CI, 9.0-11.6 to 2.2 [2.8]; 95% CI, 1.4-2.9; P < .001). Twelve participants developed mild (study-defined) ataxia, which persisted in 6 participants at 12 months. Adverse events (159 of 188 [85%] mild, 25 of 188 [13%] moderate, and 1 severe urinary tract infection) reported most commonly included numbness/tingling (n = 17 total; n = 8 at 12 months), dysarthria (n = 15 total; n = 7 at 12 months), ataxia (n = 12 total; n = 6 at 12 months), unsteadiness/imbalance (n = 10 total; n = 0 at 12 months), and taste disturbance (n = 7 total; n = 3 at 12 months). Speech difficulty, including phonation, articulation, and dysphagia, were generally mild (rated as not clinically significant, no participants with worsening in all 3 measures) and transient.
UNASSIGNED: Staged, bilateral focused ultrasound thalamotomy significantly reduced tremor severity and functional disability scores. Adverse events for speech, swallowing, and ataxia were mostly mild and transient.
UNASSIGNED: ClinicalTrials.gov Identifier NCT04112381.