Table 2:
FUS Neurosurgery ablation clinical trials. Trials were obtained from clinicaltrials.gov using search for Other terms “ExAblate OR transcranial focused ultrasound OR transcranial MRgFUS”. Up to date through December 2019. VIM = ventral intermediate nucleus, ACC = anterior cingulate cortex.
| Disease | Trial Number | Dates | Patients | Target | Primary Outcome Measure |
|---|---|---|---|---|---|
| Essential Tremor | NCT01932463 | 2011 – 2012 | 6 | Thalamotomy | Accuracy of Thalamotomy lesion |
| NCT01304758 | 2011–2012 | 15 | VIM Thalamus | Adverse events | |
| NCT02037217 | 2011–2014 | 10 | VIM Thalamus | Adverse events | |
| NCT01698450 | 2012 – 2013 | 10 | Thalamus | Lesion size / Safety | |
| NCT01827904 | 2013 – 2017 | 72 | Thalamotomy | Upper limb CRST Subscore | |
| NCT03253991 | 2014 – 2023 | 100 | Thalamotomy | Device Related Complications / Effectiveness | |
| NCT02289560 | 2015 – 2017 | 50 | Thalamotomy | Adverse Events | |
| NCT02252380 | 2015 – 2017 | 10 | VIM Thalamus | Device and Procedure related complications | |
| NCT04074031 | 2019 – 2023 | 15 | VIM Thalamus | Contralateral upper limb tremor at 3-months | |
| NCT03935581 | 2019 – 2020 | 20 | VIM Thalamus | Adverse Events | |
| NCT03465761 | 2019 – 2021 | 30 | Bilateral Thalamotomy | Clinical Rating Scale for Tremor | |
| NCT02692183 | 2018 – 2019 | 100 | Thalamotomy | EEG/ ERP recordings | |
| NCT03560622 | 2018 – 2019 | 30 | Thalamotomy | Connectivity correlates of tremor | |
| Parkinson’s Disease | NCT01772693 | 2012 – 2017 | 27 | VIM Thalamus | Device and Procedure related complications |
| NCT02347254 | 2014 – 2017 | 6 | Pallidotomy | Adverse events | |
| NCT02246374 | 2014 – 2018 | 10 | Subthalamic Nucleus | Device and Procedure related complications | |
| NCT02263885 | 2015 – 2017 | 20 | Globus Pallidum | Device and Procedure related complications | |
| NCT02912871 | 2016 – 2017 | 10 | Subthalamic Nucleus | Adverse events | |
| NCT03454425 | 2018 – 2019 | 40 | Subthalomotomy | Motor MDS-UPDRS score; Adverse events | |
| NCT04002596 | 2017 – 2020 | 50 | Thalamotomy | Clinical Rating Scale for Tremor | |
| NCT03964272 | 2019 – 2020 | 10 | Bilateral subthalamotomy | Adverse events; Motor MDS-UPDRS score | |
| NCT04112381 | 2020 – 2021 | 10 | Bilateral thalamotomy | Adverse events | |
| Dyskinesia | NCT02003248 | 2013 – 2017 | 5 | Pallidotomy | Unified Dyskinesia Rating Scale |
| NCT03319485 | 2018 – 2020 | 116 | Pallidotomy | Unified Dyskinesia Rating Scale | |
| Pain | NCT01699477 | 2008 – 2013 | 30 | Thalamus | Precision of lesioning / Adverse events / Lesion size |
| NCT03309813 | 2017 – 2019 | 10 | Thalamotomy | Device and Procedure related complications | |
| NCT03111277 | 2017 – 2021 | 5 | Thalamus | Adverse events | |
| Brain Tumors | NCT01698437 | 2011 – 2016 | 3 | Brain tumors | Adverse events / Lesion size |
| NCT01473485 | 2011 – 2017 | 10 | Brain gliomas | Adverse events | |
| NCT00147056 | 2012 – 2017 | 10 | Brain tumors | Adverse events | |
| NCT03028246 | 2017 – 2019 | 10 | Benign tumors | Adverse events / Tumor volume | |
| Obsessive Compulsive Disorder | NCT01986296 | 2013 – 2019 | 15 | ACC, internal Capsule, Ventral Striatum or Subgenual Cingulate Cortex | Effectiveness of treatment |
| Depression | NCT02348411 | 2014 – 2017 | 5 | Bilateral Anterior Capsulotomy | Hamilton Depression Rating Scale-17 |
| NCT03421574 | 2018 – 2020 | 12 | Capsulotomy | Adverse events | |
| Epilepsy | NCT02804230 | 2016 – 2019 | 10 | Subcortical focal epileptic target | Device and procedure related complications |
| NCT03417297 | 2018 – 2020 | 10 | Anterior Nucleus | Feasibility; Safety | |
| Graves’ disease | NCT03013257 | 2017 – 2020 | 266 | Thyroid parenchyma | Rate of remission |