Magnetic resonance-guided focused ultrasound surgery(MRgFUS)thalamotomy is an emerging technique for medication-refractory essential tremor(ET),but with variable outcomes.This study used pattern regression analysis to...Magnetic resonance-guided focused ultrasound surgery(MRgFUS)thalamotomy is an emerging technique for medication-refractory essential tremor(ET),but with variable outcomes.This study used pattern regression analysis to identify brain signatures predictive of tremor improvements.Fifty-four ET patients(mean age=63.06 years,standard deviation(SD)=10.55 years,38 males)underwent unilateral MRg FUS thalamotomy and were scanned for resting-state functional magnetic resonance imaging(rsf MRI).Seventy-four healthy controls(mean age=58.09 years,SD=10.30 years,38 males)were recruited for comparison.Tremor responses at 12 months posttreatment were evaluated by the Clinical Rating Scale for Tremor.The fractional amplitude of low-frequency fluctuations(f ALFF)was calculated from rs-f MRI data.Two-sample t-test was used to generate a disease-specific mask,within which Multivariate Kernel Ridge Regression analyses were conducted.Predicted and actual clinical scores were compared using Pearson's correlation coefficient(r)and normalized mean squared error(Norm.MSE).Permutation test and leave-one-out strategy were applied for results validation.KRR identified f ALFF patterns that significantly predicted the hand tremor improvement(r=0.23,P=0.025;Norm.MSE=0.05,P=0.026)and the postural tremor improvement(r=0.28,P=0.025;Norm.MSE=0.06,P=0.023),but not action tremor improvement.Lobule VI of right cerebellum(Cerebelum_6_R),right superior occipital gyrus(Occipital_Sup_R)and lobule X of vermis(Vermis_10)contributed most for hand tremor prediction(normalized weights(NW):2.77%,2.40%,2.34%)while Vermis_10,left supplementary motor area(Supp_Motor_Area_L)and right hippocampus(Hippocampus_R)for postural tremor prediction(NW:2.69%,2.12%,2.05%).The low contributing NW of the individual brain regions suggested that the f ALFF pattern as a whole is an overall predicting feature.Preoperative f ALFF pattern predicts tremor benefits induced by MRg FUS thalamotomy.Clinical Trials.gov number:NCT04570046.展开更多
The safety and effectiveness of magnetic resonance-guided focused ultrasound thalamotomy has been broadly established and validated for the treatment of essential tremor.In 2018,the first magnetic resonance-guided foc...The safety and effectiveness of magnetic resonance-guided focused ultrasound thalamotomy has been broadly established and validated for the treatment of essential tremor.In 2018,the first magnetic resonance-guided focused ultrasound system in Chinese mainland was installed at the First Medical Center of the PLA General Hospital.This prospective,single center,open-label,single-arm study was part of a worldwide prospective multicenter clinical trial(ClinicalTrials.gov Identifier:NCT03253991)conducted to confirm the safety and efficacy of magnetic resonance-guided focused ultrasound for treating essential tremor in the local population.From 2019 to 2020,10 patients with medication refractory essential tremor were recruited into this open-label,single arm study.The treatment efficacy was determined using the Clinical Rating Scale for Tremor.Safety was evaluated according to the incidence and severity of adverse events.All of the subjects underwent a unilateral thalamotomy targeting the ventral intermediate nucleus.At the baseline assessment,the estimated marginal mean of the Clinical Rating Scale for Tremor total score was 58.3±3.6,and this improved after treatment to 23.1±6.4 at a 12-month follow-up assessment.A total of 50 adverse events were recorded,and 2 were defined as serious.The most common intraoperative adverse events were nausea and headache.The most frequent postoperative adverse events were paresthesia and equilibrium disorder.Most of the adverse events were mild and usually disappeared within a few days.Our findings suggest that magnetic resonance-guided focused ultrasound for the treatment of essential tremor is effective,with a good safety profile,for patients in Chinese mainland.展开更多
Magnetic resonance-guided focused ultrasound surgery (MRgFUS) is an emerging, non-invasive hyperthermia technology which can be used for the treatment of benign and malignant tumours, in conjunction with intracranial ...Magnetic resonance-guided focused ultrasound surgery (MRgFUS) is an emerging, non-invasive hyperthermia technology which can be used for the treatment of benign and malignant tumours, in conjunction with intracranial neurological diseases. To treat different indications, it is often necessary to design special focused ultrasound devices and treatment plans, which poses great challenges and results in substantial costs during software development. This article introduces a general software architecture that can be applied to three different focused ultrasound devices for the treatment of uterine fibroids, breast fibroids, and pain palliation of bone metastases, respectively, and can be integrated with GE Discovery or Signa MRI scanners and Xingaoyi BroadScan MRI scanners. Finally, the proposed software architecture was shown to possess desirable universality and safety through various tests and animal experimental studies.展开更多
To investigate the evaluation value of intravoxel incoherent motion diffusion-weighted imaging(IVIM-DWI)on the early efficacy of magnetic resonance-guided high-intensity focused ultrasound(MRgFUS)ablation for uterine ...To investigate the evaluation value of intravoxel incoherent motion diffusion-weighted imaging(IVIM-DWI)on the early efficacy of magnetic resonance-guided high-intensity focused ultrasound(MRgFUS)ablation for uterine adenomyoma.The clinical and magnetic resonance imaging(MRI)data of 36 patients with uterine adenomyoma before and after MRgFUS treatment in our hospital from January 2018 to December 2018 were retrospectively analyzed.All the 36 patients underwent MRI examination one day before operation and immediately after operation using GE Discovery MR7503.0T MRI,including conventional sequences(T1WI,T2WI,and T2 fat suppression sequences)plain scan,IVIM-DWI sequences with 9 b values,and contrast enhanced-MRI sequences.The IVIM-DWI quantitative parameters(true diffusion coefficient D,perfusion related diffusion coefficient D*,and perfusion fraction f)of double-exponential model were obtained by using GE ADW 4.7 functool,a postprocessor.SPSS 24.0 software was used to analyze the difference in parameter between the ablation and non-ablation areas of uterine adenomyoma.DWI signal in the ablation area of uterine adenomyoma was increased,and manifested as heterogeneous diffuse high signal,with low central signal and high edge signal.Values of D,D*and f in the ablation area of uterine adenomyoma were significantly lower than those in the non-ablation area,and there was statistical difference between the two(P<0.05).The areas under receiver operating characteristic(ROC)curve of D,D*and f values in the ablation area of uterine adenomyoma were 0.854,0.898 and 0.924,respectively;the optimal thresholds for the diagnosis of ablation area of uterine adenomyoma were 0.81×10−3 mm2/s,4.99×10−3 mm2/s and 0.24,respectively;the diagnostic sensitivity was 80.6%,72.2%and 94.4%,respectively;and the specificity was 91.7%,97.2%and 94.4%,respectively.IVIM-DWI has a certain clinical value in the evaluation on early efficacy of MRgFUS ablation of uterine adenomyosis.展开更多
Background: COVID-19 limitations have hindered the implementation of new technologies by preventing proctors from coming to the site.We share our first experience of magnetic resonance imaging(MRI)-guided focused ultr...Background: COVID-19 limitations have hindered the implementation of new technologies by preventing proctors from coming to the site.We share our first experience of magnetic resonance imaging(MRI)-guided focused ultrasound(MRgFUS)treatment with an international remote online proctorship,and develop and evaluate the methodology of remote MRgFUS proctorship.Methods: This single-center,nonrandomized controlled prospective study included 94 patients:27 with essential tremor(ET)and 67 with tremor-dominant Parkinson's disease(PD).The coming of proctors was impossible,so we arranged for the remote participation of proctors from the United Kingdom,Spain,and Israel.A total of 38 patients(40.4%)received telemedicine-proctored treatment(proctor group)and 56 received their treatment independently(solo group).We used the Clinical Rating Scale for Tremor(CRST)for ET patients and the Unified Parkinson's Disease Rating Scale(UPDRS)Part III for PD patients.Results: In patients with ET,success rates were 81.8%(proctor group)and 100%(solo group)(p=0.22).CRST reduction on the treated side was 71.43%[65.83%;80.56%](proctor group)versus 60.87%[53.99;79.58](solo group)(p=0.19).None of the patients showed worsening of tremors within 1 year.In patients with PD,the success rates were 92.6%(proctor group)and 100%(solo group)(p=0.08).The UPDRS Part III improvement was 30.1%(proctor group)versus 39.9%(solo group)(p=0.003).The 1-year recurrence rate was 40%(proctor group)and 17.5%(solo group)(p=0.04).No complications were observed at 6 months.Conclusions: We developed a feasible and safe methodology for telemedicine remote online-proctored MRgFUS treatment.No significant difference was observed between the solo and developed remote proctor protocols in terms of complication rate,effect,and long-term results;however,UPDRS Part III improvement was better in the PD solo group.This study demonstrated that the MRgFUS international proctorship can be performed successfully remotely.展开更多
基金supported by the National Natural Science Foundation of China(82302146,82151309,and 81825012).
文摘Magnetic resonance-guided focused ultrasound surgery(MRgFUS)thalamotomy is an emerging technique for medication-refractory essential tremor(ET),but with variable outcomes.This study used pattern regression analysis to identify brain signatures predictive of tremor improvements.Fifty-four ET patients(mean age=63.06 years,standard deviation(SD)=10.55 years,38 males)underwent unilateral MRg FUS thalamotomy and were scanned for resting-state functional magnetic resonance imaging(rsf MRI).Seventy-four healthy controls(mean age=58.09 years,SD=10.30 years,38 males)were recruited for comparison.Tremor responses at 12 months posttreatment were evaluated by the Clinical Rating Scale for Tremor.The fractional amplitude of low-frequency fluctuations(f ALFF)was calculated from rs-f MRI data.Two-sample t-test was used to generate a disease-specific mask,within which Multivariate Kernel Ridge Regression analyses were conducted.Predicted and actual clinical scores were compared using Pearson's correlation coefficient(r)and normalized mean squared error(Norm.MSE).Permutation test and leave-one-out strategy were applied for results validation.KRR identified f ALFF patterns that significantly predicted the hand tremor improvement(r=0.23,P=0.025;Norm.MSE=0.05,P=0.026)and the postural tremor improvement(r=0.28,P=0.025;Norm.MSE=0.06,P=0.023),but not action tremor improvement.Lobule VI of right cerebellum(Cerebelum_6_R),right superior occipital gyrus(Occipital_Sup_R)and lobule X of vermis(Vermis_10)contributed most for hand tremor prediction(normalized weights(NW):2.77%,2.40%,2.34%)while Vermis_10,left supplementary motor area(Supp_Motor_Area_L)and right hippocampus(Hippocampus_R)for postural tremor prediction(NW:2.69%,2.12%,2.05%).The low contributing NW of the individual brain regions suggested that the f ALFF pattern as a whole is an overall predicting feature.Preoperative f ALFF pattern predicts tremor benefits induced by MRg FUS thalamotomy.Clinical Trials.gov number:NCT04570046.
基金sponsored by Insightec Co.Ltd.(Israel)China National Clinical Research Center for Geriatrics,No.NCRCG-PLAGH-2019005 (to LP)
文摘The safety and effectiveness of magnetic resonance-guided focused ultrasound thalamotomy has been broadly established and validated for the treatment of essential tremor.In 2018,the first magnetic resonance-guided focused ultrasound system in Chinese mainland was installed at the First Medical Center of the PLA General Hospital.This prospective,single center,open-label,single-arm study was part of a worldwide prospective multicenter clinical trial(ClinicalTrials.gov Identifier:NCT03253991)conducted to confirm the safety and efficacy of magnetic resonance-guided focused ultrasound for treating essential tremor in the local population.From 2019 to 2020,10 patients with medication refractory essential tremor were recruited into this open-label,single arm study.The treatment efficacy was determined using the Clinical Rating Scale for Tremor.Safety was evaluated according to the incidence and severity of adverse events.All of the subjects underwent a unilateral thalamotomy targeting the ventral intermediate nucleus.At the baseline assessment,the estimated marginal mean of the Clinical Rating Scale for Tremor total score was 58.3±3.6,and this improved after treatment to 23.1±6.4 at a 12-month follow-up assessment.A total of 50 adverse events were recorded,and 2 were defined as serious.The most common intraoperative adverse events were nausea and headache.The most frequent postoperative adverse events were paresthesia and equilibrium disorder.Most of the adverse events were mild and usually disappeared within a few days.Our findings suggest that magnetic resonance-guided focused ultrasound for the treatment of essential tremor is effective,with a good safety profile,for patients in Chinese mainland.
基金the National Natural Science Foundation of China (Nos. 81727806 and 11774231)the National Key Research and Development Program of Ministry of Science and Technology (No. 2017YFC0108900)+1 种基金the Shanghai Municipal Education Commission—Gaofeng Clinical Medicine Grant Support—Gainers from Shanghai Jiao Tong University School of Medicine (No. 20152230)the Emerging Frontier Technology Joint Research Program of Shanghai Shen-Kang Hospital Development Center (No. SHDC2017127)。
文摘Magnetic resonance-guided focused ultrasound surgery (MRgFUS) is an emerging, non-invasive hyperthermia technology which can be used for the treatment of benign and malignant tumours, in conjunction with intracranial neurological diseases. To treat different indications, it is often necessary to design special focused ultrasound devices and treatment plans, which poses great challenges and results in substantial costs during software development. This article introduces a general software architecture that can be applied to three different focused ultrasound devices for the treatment of uterine fibroids, breast fibroids, and pain palliation of bone metastases, respectively, and can be integrated with GE Discovery or Signa MRI scanners and Xingaoyi BroadScan MRI scanners. Finally, the proposed software architecture was shown to possess desirable universality and safety through various tests and animal experimental studies.
文摘To investigate the evaluation value of intravoxel incoherent motion diffusion-weighted imaging(IVIM-DWI)on the early efficacy of magnetic resonance-guided high-intensity focused ultrasound(MRgFUS)ablation for uterine adenomyoma.The clinical and magnetic resonance imaging(MRI)data of 36 patients with uterine adenomyoma before and after MRgFUS treatment in our hospital from January 2018 to December 2018 were retrospectively analyzed.All the 36 patients underwent MRI examination one day before operation and immediately after operation using GE Discovery MR7503.0T MRI,including conventional sequences(T1WI,T2WI,and T2 fat suppression sequences)plain scan,IVIM-DWI sequences with 9 b values,and contrast enhanced-MRI sequences.The IVIM-DWI quantitative parameters(true diffusion coefficient D,perfusion related diffusion coefficient D*,and perfusion fraction f)of double-exponential model were obtained by using GE ADW 4.7 functool,a postprocessor.SPSS 24.0 software was used to analyze the difference in parameter between the ablation and non-ablation areas of uterine adenomyoma.DWI signal in the ablation area of uterine adenomyoma was increased,and manifested as heterogeneous diffuse high signal,with low central signal and high edge signal.Values of D,D*and f in the ablation area of uterine adenomyoma were significantly lower than those in the non-ablation area,and there was statistical difference between the two(P<0.05).The areas under receiver operating characteristic(ROC)curve of D,D*and f values in the ablation area of uterine adenomyoma were 0.854,0.898 and 0.924,respectively;the optimal thresholds for the diagnosis of ablation area of uterine adenomyoma were 0.81×10−3 mm2/s,4.99×10−3 mm2/s and 0.24,respectively;the diagnostic sensitivity was 80.6%,72.2%and 94.4%,respectively;and the specificity was 91.7%,97.2%and 94.4%,respectively.IVIM-DWI has a certain clinical value in the evaluation on early efficacy of MRgFUS ablation of uterine adenomyosis.
文摘Background: COVID-19 limitations have hindered the implementation of new technologies by preventing proctors from coming to the site.We share our first experience of magnetic resonance imaging(MRI)-guided focused ultrasound(MRgFUS)treatment with an international remote online proctorship,and develop and evaluate the methodology of remote MRgFUS proctorship.Methods: This single-center,nonrandomized controlled prospective study included 94 patients:27 with essential tremor(ET)and 67 with tremor-dominant Parkinson's disease(PD).The coming of proctors was impossible,so we arranged for the remote participation of proctors from the United Kingdom,Spain,and Israel.A total of 38 patients(40.4%)received telemedicine-proctored treatment(proctor group)and 56 received their treatment independently(solo group).We used the Clinical Rating Scale for Tremor(CRST)for ET patients and the Unified Parkinson's Disease Rating Scale(UPDRS)Part III for PD patients.Results: In patients with ET,success rates were 81.8%(proctor group)and 100%(solo group)(p=0.22).CRST reduction on the treated side was 71.43%[65.83%;80.56%](proctor group)versus 60.87%[53.99;79.58](solo group)(p=0.19).None of the patients showed worsening of tremors within 1 year.In patients with PD,the success rates were 92.6%(proctor group)and 100%(solo group)(p=0.08).The UPDRS Part III improvement was 30.1%(proctor group)versus 39.9%(solo group)(p=0.003).The 1-year recurrence rate was 40%(proctor group)and 17.5%(solo group)(p=0.04).No complications were observed at 6 months.Conclusions: We developed a feasible and safe methodology for telemedicine remote online-proctored MRgFUS treatment.No significant difference was observed between the solo and developed remote proctor protocols in terms of complication rate,effect,and long-term results;however,UPDRS Part III improvement was better in the PD solo group.This study demonstrated that the MRgFUS international proctorship can be performed successfully remotely.
