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    Other relevant studies

    Other potentially relevant studies to the IP overview that were not included in the main evidence summary (tables 2 and 3) are listed in table 5.

    Table 5 additional studies identified

    Article

    Number of patients and follow up

    Direction of conclusions

    Reason study was not included in main evidence summary

    Cummins DD, Bernabei JM, Wang DD. (2024) Focused ultrasound for treatment of movement disorders: A review of non-food and drug administration approved indications. Stereotact Funct Neurosurg; 102:93–108.

    Review on FUS for non-FDA approved movement disorders.

    Subthalamic nucleus (STN)-FUS for PD gave approximately 50% improvement in PD motor symptoms, with dystonia and mild dyskinesias as possible adverse effects that required medical management. 

    Review

    Jung NY, Chang JW. (2018) Magnetic resonance-guided focused ultrasound in neurosurgery: taking lessons from the past to inform the future. J Korean Med Sci. 33(44): e279.

    Review

    MRgFUS for subthalomotomy is an emerging procedure and a pilot study found that the mean UPDRS part III scores in the treated hemibody improved by 53% from baseline to 6 months in the off-medication state and by 47% in the on-medication state.

    Review

    Jorge U. Máñez-Miró, Rafael Rodríguez-Rojas, Marta Del Álamo, R. Martínez-Fernández & José A. Obeso (2021) Present and future of subthalamotomy in the management of Parkinson ́s disease: a systematic review, Expert Review of Neurotherapeutics, 21:5,533-545,

    Systematic review on subthalamotomy for PD

    Unilateral subthalamotomy for the treatment of PD motor features can be considered a viable option in asymmetric patients, particularly with FUS which allows a minimally invasive safe and effective ablation of the STN. Risk of inducing dyskinesia (i.e., hemichorea/ballism) may be strikingly reduced when lesions enlarge dorsally to impinge on pallidothalamic fibers

    Evidence regarding subthalamotomy both with radiofrequency and FUS assessed together.

    Lin SJ, Rodriguez-Rojas R, Baumeister TR et al. (2022) Neuroimaging signatures predicting motor improvement to focused ultrasound subthalamotomy in Parkinson's disease. NPJ Parkinsons Dis; 8(1):70. doi: 10.1038/s41531-022-00332-9. 

    Functional and structural neuroimaging and extensive clinical data from thirty-five PD patients enrolled in a double-blind MRgFUS-subthalamotomy clinical trial were analysed.

    findings reveal specific quantitative brain signatures highly predictive of MRgFUS-subthalamotomy responsiveness in PD. The unanticipated weight of a cortical-subcortical-cerebellar subnetwork in defining clinical outcome extends the current biological understanding of the mechanisms associated with clinical benefits.

    Assesses brain imaging features.

    Maesawa S, Nakatsubo D, Tsugawa T et al. (2021) Techniques, indications, and outcomes in magnetic resonance-guided focused ultrasound thalamotomy for tremor. Neurol Med Chir (Tokyo). 15;61(11):629-639.

    Review

    A small pilot study reported that the motor score of the UPDRS improved postoperatively by 53% during on-medication and by 47% during off-medication. A RCT for subthalamotomy demonstrated promising results.

    Review

    Máñez-Miró JU, Rodríguez-Rojas R, Del Álamo M, et al. (2021) Present and future of subthalamotomy in the management of Parkinson´s disease: a systematic review. Expert Rev Neurother. 21(5):533-545.

    Systematic review and expert opinion.

    Unilateral subthalamotomy for the treatment of PD motor features can be considered a viable option in asymmetric patients, particularly with FUS which allows a minimally invasive safe and effective ablation of the STN. Risk of inducing dyskinesia (hemichorea/ballism) may be strikingly reduced when lesions enlarge dorsally to impinge on pallidothalamic fibers.

    evidence regarding subthalamotomy both with radiofrequency and, with FUS assessed.

    Martínez-Fernández R, Matarazzo M, Máñez-Miró JU et al. (2021) The role of focused ultrasound in the management of movement disorders: Insights after 5 Years of experience. Mov Disord Clin Pract. 23;8(5):681-687.

    review

    provides insights into the current evidence as well as a perspective for the potential future applications of FUS ablation in movement disorders, considering experience since 2015.

    covers all movement disorders.

    Rodriguez-Rojas R, Pineda-Pardo JA, Martinez-Fernandez R et al. (2020) Functional impact of subthalamotomy by magnetic resonance-guided focused ultrasound in Parkinson's disease: a hybrid PET/MR study of resting-state brain metabolism. Eur J Nucl Med Mol Imaging. 47(2):425-436.

    n=8 patients with unilateral MRgFUS-subthalamotomy hybrid [18F] FDG-PET/MR imaging study

    MRgFUS-subthalamotomy induced metabolic alterations in distributed nodes of the motor, associative, and limbic circuits. Clinical improvement was associated with reduction in the PD-related covariance pattern expression. This treatment-induced modulation of the metabolic network is likely to mediate the clinical benefit achieved.

    effect on brain metabolism.

    Tian X, Hu R, He P et al. (2023) Efficacy and safety of magnetic resonance-guided focused ultrasound for Parkinson's disease: a systematic review and meta-analysis. Frontiers in Neurology, 14:1301240.

    Systematic review and meta-analysis 20 studies involving 258 patients with drug-resistant Parkinson's disease.

    MRgFUS offers an effective and relatively safe treatment option for patients with drug-resistant PD-related tremor.

    Study includes different ablation targets (VIM, GPI, PTT and STN). There is no sub-group analysis of different ablation targets. 

    Tzu-Hsiang K, Yu-Hsuan L, Lung C et al. (2023) Magnetic resonance–guided focused ultrasound surgery for Parkinson's disease: A mini-review and comparison between deep brain stimulation. Parkinsonism & Related Disorders

    Volume 111, June 2023, 105431

    Review

    The present study reviews the literature on conventional surgical interventions for PD, discusses recent studies on MRgFUS, and the comparison between DBS and MRgFUS for PD. The reviews aims to provide an essential reference for neurologists to select the appropriate treatments for patients with PD.

    Review