磁共振引导超声聚焦系统(“磁波刀”)在治疗特发性震颤中的应用
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摘要
目的验证"磁波刀"治疗药物难治性特发震颤的有效性和安全性。方法根据ET002J临床试验方案,筛选解放军总医院第一医学中心受试者于2019年1月进行治疗。采用临床震颤评定量表(CRST)评价震颤症状。所有患者采取"磁波刀"左侧丘脑腹中间核毁损术治疗。结果入选受试者男性2例,女性1例,年龄分别为66岁、76岁和66岁;病程均超过10年,均有家族史,确诊为难治性特发震颤。治疗后,429301号受试者CRST量表中Part A评分从术前20分改善到11分,429302号受试者从16分改善到6分,429303号受试者从16分改善到7分,平均改善超过50%。所有受试者书写能力均得到明显改善。术后除1例出现短暂平衡障碍,其余受试者无不良反应。结论本中心完成的3例药物难治性特发震颤的"磁波刀"治疗,取得良好治疗效果,初步验证了该设备对特发震颤治疗的适用性,为其下一步应用治疗于中枢神经系统其他重大疾病奠定了基础。
Objective To verify the effectiveness and safety of MR-guided focused ultrasound(MRgFUS) in treatment of refractory essential tremor. Methods According to the ET002 J clinical trial protocol, subjects were recruited from the first medical center of Chinese PLA General Hospital in January 2019. The symptoms of tremor were evaluated using CRST scale. All patients underwent left ventral medial nucleus ablation by MRgFUS. Results Totally 3 subjects were recruited in our study, including an 66 year-old male, a 76 year-old male and a 66 year-old female. The duration of symptom in the three patients was over 10 years, and they all had a family history. All of them could be identified as refractory essential tremor. At baseline vs after treatment, the resting, postural and action tremor score of CRST scale was 20 vs 11 in subject 429301, 16 vs 6 in subject 429302, and 16 vs 7 in subject 429303, with an average improvement over 50%. Their handwritings were also significantly improved. One subject experienced transient balance disorder, while no adverse reaction was observed in other two subjects. Conclusion We preliminarily proved MRgFUS favorable efficacy and safety in treatment of refractory essential tremor, which indicating a promising practice applicability and providing evidences for further application in other major central nervous system diseases.
Objective To verify the effectiveness and safety of MR-guided focused ultrasound(MRgFUS) in treatment of refractory essential tremor. Methods According to the ET002 J clinical trial protocol, subjects were recruited from the first medical center of Chinese PLA General Hospital in January 2019. The symptoms of tremor were evaluated using CRST scale. All patients underwent left ventral medial nucleus ablation by MRgFUS. Results Totally 3 subjects were recruited in our study, including an 66 year-old male, a 76 year-old male and a 66 year-old female. The duration of symptom in the three patients was over 10 years, and they all had a family history. All of them could be identified as refractory essential tremor. At baseline vs after treatment, the resting, postural and action tremor score of CRST scale was 20 vs 11 in subject 429301, 16 vs 6 in subject 429302, and 16 vs 7 in subject 429303, with an average improvement over 50%. Their handwritings were also significantly improved. One subject experienced transient balance disorder, while no adverse reaction was observed in other two subjects. Conclusion We preliminarily proved MRgFUS favorable efficacy and safety in treatment of refractory essential tremor, which indicating a promising practice applicability and providing evidences for further application in other major central nervous system diseases.
引文
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3 Haubenberger D,Hallett M.Essential Tremor[J].N Engl J Med,2018,378(19):1802-1810.
4 FDA approves first MRI-guided focused ultrasound device to treat essential tremor[EB/OL].https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm510595.htm
5 Jung NY,Chang JW.Magnetic Resonance-Guided Focused Ultrasound in Neurosurgery:Taking Lessons from the Past to Inform the Future[J].J Korean Med Sci,2018,33(44):e279.
6 A Study to Evaluate the Effectiveness and Safety of ExAblate MRgFUSon Essential Tremor[EB/OL].https://clinicaltrials.gov/ct2/show/NCT03253991?term=InSightec&draw=2&rank=14
7 Bhatia KP,Bain P,Bajaj N,et al.Consensus Statement on the classification of tremors.from the task force on tremor of the International Parkinson and Movement Disorder Society[J].Mov Disord,2018,33(1):75-87.
8 Elias WJ,Khaled M,Hilliard JD,et al.A magnetic resonance imaging,histological,and dose modeling comparison of focused ultrasound,radiofrequency,and Gamma Knife radiosurgery lesions in swine thalamus[J].J Neurosurg,2013,119(2):307-317.
9 Elias WJ,Huss D,Voss T,et al.A pilot study of focused ultrasound thalamotomy for essential tremor[J].N Engl J Med,2013,369(7):640-648.
10 Lipsman N,Schwartz ML,Huang Y,et al.MR-guided focused ultrasound thalamotomy for essential tremor:a proof-of-concept study[J].Lancet Neurol,2013,12(5):462-468.
11 Chang WS,Jung HH,Kweon EJ,et al.Unilateral magnetic resonance guided focused ultrasound thalamotomy for essential tremor:practices and clinicoradiological outcomes[J].J Neurol Neurosurg Psychiatry,2015,86(3):257-264.
12 Elias WJ,Lipsman N,Ondo WG,et al.A Randomized Trial of Focused Ultrasound Thalamotomy for Essential Tremor[J].N Engl J Med,2016,375(8):730-739.
13 Jung NY,Park CK,Chang WS,et al.Effects on cognition and quality of life with unilateral magnetic resonance-guided focused ultrasound thalamotomy for essential tremor[J].Neurosurg Focus,2018,44(2):E8.
14 Zaaroor M,Sinai A,Goldsher D,et al.Magnetic resonance-guided focused ultrasound thalamotomy for tremor:a report of 30 Parkinson's disease and essential tremor cases[J].J Neurosurg,2018,128(1):202-210.
15 Iacopino DG,Gagliardo C,Giugno A,et al.Preliminary experience with a transcranial magnetic resonance-guided focused ultrasound surgery system integrated with a 1.5-T MRI unit in a series of patients with essential tremor and Parkinson's disease[J].Neurosurg Focus,2018,44(2):E7.
16 Mohammed N,Patra D,Nanda A.Erratum.A meta-analysis of outcomes and complications of magnetic resonance-guided focused ultrasound in the treatment of essential tremor[J].Neurosurg Focus,2018,45(1):E16.
17 Chang JW,Park CK,Lipsman N,et al.A prospective trial of magnetic resonance-guided focused ultrasound thalamotomy for essential tremor:Results at the 2-year follow-up[J].Ann Neurol,2018,83(1):107-114.
18 Fishman PS,Elias WJ,Ghanouni P,et al.Neurological adverse event profile of magnetic resonance imaging-guided focused ultrasound thalamotomy for essential tremor[J].Mov Disord,2018,33(5):843-847.
2 Louis ED.The Roles of Age and Aging in Essential Tremor:An Epidemiological Perspective[J].Neuroepidemiology,2019,52(1-2):111-118.
3 Haubenberger D,Hallett M.Essential Tremor[J].N Engl J Med,2018,378(19):1802-1810.
4 FDA approves first MRI-guided focused ultrasound device to treat essential tremor[EB/OL].https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm510595.htm
5 Jung NY,Chang JW.Magnetic Resonance-Guided Focused Ultrasound in Neurosurgery:Taking Lessons from the Past to Inform the Future[J].J Korean Med Sci,2018,33(44):e279.
6 A Study to Evaluate the Effectiveness and Safety of ExAblate MRgFUSon Essential Tremor[EB/OL].https://clinicaltrials.gov/ct2/show/NCT03253991?term=InSightec&draw=2&rank=14
7 Bhatia KP,Bain P,Bajaj N,et al.Consensus Statement on the classification of tremors.from the task force on tremor of the International Parkinson and Movement Disorder Society[J].Mov Disord,2018,33(1):75-87.
8 Elias WJ,Khaled M,Hilliard JD,et al.A magnetic resonance imaging,histological,and dose modeling comparison of focused ultrasound,radiofrequency,and Gamma Knife radiosurgery lesions in swine thalamus[J].J Neurosurg,2013,119(2):307-317.
9 Elias WJ,Huss D,Voss T,et al.A pilot study of focused ultrasound thalamotomy for essential tremor[J].N Engl J Med,2013,369(7):640-648.
10 Lipsman N,Schwartz ML,Huang Y,et al.MR-guided focused ultrasound thalamotomy for essential tremor:a proof-of-concept study[J].Lancet Neurol,2013,12(5):462-468.
11 Chang WS,Jung HH,Kweon EJ,et al.Unilateral magnetic resonance guided focused ultrasound thalamotomy for essential tremor:practices and clinicoradiological outcomes[J].J Neurol Neurosurg Psychiatry,2015,86(3):257-264.
12 Elias WJ,Lipsman N,Ondo WG,et al.A Randomized Trial of Focused Ultrasound Thalamotomy for Essential Tremor[J].N Engl J Med,2016,375(8):730-739.
13 Jung NY,Park CK,Chang WS,et al.Effects on cognition and quality of life with unilateral magnetic resonance-guided focused ultrasound thalamotomy for essential tremor[J].Neurosurg Focus,2018,44(2):E8.
14 Zaaroor M,Sinai A,Goldsher D,et al.Magnetic resonance-guided focused ultrasound thalamotomy for tremor:a report of 30 Parkinson's disease and essential tremor cases[J].J Neurosurg,2018,128(1):202-210.
15 Iacopino DG,Gagliardo C,Giugno A,et al.Preliminary experience with a transcranial magnetic resonance-guided focused ultrasound surgery system integrated with a 1.5-T MRI unit in a series of patients with essential tremor and Parkinson's disease[J].Neurosurg Focus,2018,44(2):E7.
16 Mohammed N,Patra D,Nanda A.Erratum.A meta-analysis of outcomes and complications of magnetic resonance-guided focused ultrasound in the treatment of essential tremor[J].Neurosurg Focus,2018,45(1):E16.
17 Chang JW,Park CK,Lipsman N,et al.A prospective trial of magnetic resonance-guided focused ultrasound thalamotomy for essential tremor:Results at the 2-year follow-up[J].Ann Neurol,2018,83(1):107-114.
18 Fishman PS,Elias WJ,Ghanouni P,et al.Neurological adverse event profile of magnetic resonance imaging-guided focused ultrasound thalamotomy for essential tremor[J].Mov Disord,2018,33(5):843-847.