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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

    Dahmani, L., Bai, Y., Li, M., et al. (2023). Focused ultrasound thalamotomy for tremor treatment impacts the cerebello-thalamo-cortical network. npj Parkinson's Disease, 9(1), 90.

    Non-randomised controlled trial

    N=13

    MRgFUS is a highly efficient treatment for tremor, and that lesioning the VIM may result in the reorganization of the

    cerebello-thalamo-cortical tremor network.

    More comprehensive studies added to evidence summary. Not all patients had PD, some had ET.

    Fasano, A., Llinas, M., Munhoz, et al. (2017). MRI-guided focused ultrasound thalamotomy in non-ET tremor syndromes. Neurology, 89(8), 771-775.

    Case series

    N=6 (3 PD, 2 dystonic tremor and 1 dystonia gene–associated tremor)

    Vim MRgFUS is a promising, incision-free, but invasive technique to effectively treat tremors but further future studies on larger samples and longer follow-up are necessary to assess effectiveness and safety.

    More comprehensive studies added to evidence summary. Not all patients had PD.

    Golfrè Andreasi, N., Cilia, R., Romito, et al. (2022). Magnetic resonance–guided focused ultrasound thalamotomy may spare dopaminergic therapy in early‐stage tremor‐dominant Parkinson's disease: a pilot study. Movement Disorders, 37(11), 2289-2295.

    Prospective case series

    N=10

    In early-stage tremor-dominant PD, MRgFUS thalamotomy may be useful to reduce tremor and avoid the need to increase dopaminergic medications.

    More comprehensive studies added to evidence summary. Results were based on patients receiving FUS and oral dopaminergic therapy.

    Iacopino, D. G., Gagliardo, C., Giugno, A., Giammalva, G. R., Napoli, A., Maugeri, R., ... & Lagalla, R. (2018). 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. Neurosurgical Focus, 44(2), E7.

    Case series

    N=26

    The transcranial MRgFUS procedure using a 1.5-T MRI unit resulted in a safe and effective treatment option for motor symptoms in patients with ET and PD.

    More comprehensive studies added to evidence summary. Not all patients had PD, some had ET.

    Jung, N. Y., & Chang, J. W. (2018). Magnetic resonance-guided focused ultrasound in neurosurgery: taking lessons from the past to inform the future. Journal of Korean medical science, 33(44).

    Review article

    MRgFUS is an important first step for the ideal neurosurgery for neurological disorders

    due to its non-invasive nature and safety. Larger scaled data from phase II and III trials are necessary to confirm the efficacy.

    More comprehensive studies added to evidence summary.

    Ko, T. H., Lee, Y. H., Chan, L.,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, 105431.

    Literature review of 20 studies

    N=258

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

    More comprehensive studies added to evidence summary. This systematic review contains data from papers with ablation targets other than the thalamus.

    Lennon, J.C. and Hassan, I., 2021. Magnetic resonance-guided focused ultrasound for Parkinson's disease since ExAblate, 2016–2019: a systematic review. Neurological Sciences, 42, pp.553-563.

    Systematic review of 2 studies

    N= 37

    Follow-up of 12 months

    This systematic review demonstrates a substantial gap in the literature that must be addressed.

    More comprehensive studies added to evidence summary.

    Lu, H., Wang, X., & Lou, X. (2023). Current applications for magnetic resonance-guided focused ultrasound in the treatment of Parkinson's disease. Chinese Medical Journal, 136(07), 780-787.

    Systematic review of 8 studies

    N=128

    12 months follow up

    MRgFUS is an effective therapy for the treatment of PD . However, further clinical

    trials are required to assess the long-term efficacy and

    potential risks of MRgFUS.

    More comprehensive studies added to evidence summary. This systematic review contains data from papers with ablation targets other than the thalamus.

    Magara, A., Bühler, R., Moser, D et al. (2014). First experience with MR-guided focused ultrasound in the treatment of Parkinson's disease. Journal of Therapeutic Ultrasound2, 1-8.

    Case series

    N=13

    This study demonstrated the feasibility, safety, and accuracy of the MRgFUS pallidothalamic tractotomy.

    More comprehensive studies added to evidence summary.

    Maragkos, G.A., Kosyakovsky, J., Zhao, P., et al. (2022) Patient-Reported Outcomes After Focused Ultrasound Thalamotomy for Tremor-Predominant Parkinson's Disease. Neurosurgery, pp.10-1227.

    Retrospective study

    N=29

    16 months follow up

    Patient satisfaction with FUS thalamotomy for tremor-predominant PD was very high, even at longer term.

    More comprehensive studies added to evidence summary.

    Ogrodnik R, Sepulveda MC, Fernandez E (2022) Magnetic resonance-guided focused ultrasound thalamotomy for tremor: First experience in Latin America. MOVEMENT DISORDERS CLINICAL PRACTICE (S1): S8–S73

    Conference abstract

    N=20 (10 ET and 10 PD)

    MRgFUS thalamotomy has shown good results in the treatment of Parkinson's. The procedure is well tolerated, and adverse events were found to be generally mild and/or transient. However, longer follow-up is needed to confirm results.

    More comprehensive studies added to evidence summary.

    Rodríguez Oroz M C, Parras O, Gorospe A (2020) Efficacy of unilateral thalamotomy by MRgFUS in essential tremor and Parkinson's disease in a large cohort of patients. Movement Disorders (Vol. 35, Suppl. S1)

    Conference abstract

    N=135 (88 ET and 47 PD)

    MRgFUS thalamotomy for Parkinson's is associated with a great improvement in tremor at 3-month follow-up. Although side effects are frequent, the vast majority are mild without any clinical relevance.

    More comprehensive studies added to evidence summary.

    Rohani, M., & Fasano, A. (2017). Focused ultrasound for essential tremor: review of the evidence and discussion of current hurdles. Tremor and Other Hyperkinetic Movements7.

    Narrative review

    Studies have shown the safety and effectiveness of unilateral MRgFUS thalamotomy in the treatment of ET. It has been successfully used in a few patients with Parkinson's disease-related tremor, and in fewer patients with fragile X-associated tremor/ataxia syndrome. The safety and long-term effects of the procedure are still unclear, as temporary and permanent adverse events have been reported as well as recurrence of tremor.

    More comprehensive studies added to evidence summary.

    Schlesinger, I., Eran, A., Sinai, A., al. (2015). MRI guided focused ultrasound thalamotomy for moderate-to-severe tremor in Parkinson's disease. Parkinson's disease, 2015.

    Case series

    N=7

    Thalamotomy using MRgFUS is safe and effective in PD patients. Large randomized studies are needed to assess prolonged efficacy and safety.

    More comprehensive studies added to evidence summary.

    Stanziano, M., Golfrè Andreasi, et al. (2022). Resting state functional connectivity signatures of MRgFUS vim Thalamotomy in Parkinson's disease: a preliminary study. Frontiers in Neurology, 12, 786734.

    Prospective case series

    N=20

    MRgFUS can effectively modulate brain functional connectivity within the tremor network and related changes are associated with clinical outcome.

    More comprehensive studies added to evidence summary.

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

    Systematic review and meta-analysis of 20 studies

    N=258

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

    More comprehensive studies added to evidence summary. This systematic review contains data from papers with ablation targets other than the thalamus.

    Wang, X., Wang, S., Lin, J., et al.. (2023). Gray matter alterations in tremor-dominant Parkinson's disease after MRgFUS thalamotomy are correlated with tremor improvement: a pilot study. Quantitative Imaging in Medicine and Surgery, 13(7), 4415.

    Prospective case series

    N=9

    Grey matter volume can be used to reflect tremor improvement after MRgFUS thalamotomy.

    More comprehensive studies added to evidence summary.

    Xu, Y., He, Q., Wang, et al. (2021) Safety and efficacy of magnetic resonance imaging-guided focused ultrasound neurosurgery for Parkinson's disease: a systematic review. Neurosurgical Review, 44, pp.115-127.

    Systematic review of 11 studies

    N=147

    Follow-up ranging from 3 weeks to 30 months

    Most adverse events were mild and transient. MRgFUS is a potential treatment for PD with satisfying efficacy and safety.

    More comprehensive studies added to evidence summary.

    Yongqin Xiong, Dongshan Han, Jianfeng He et al. (2022) Correlation of visual area with tremor improvement after MRgFUS thalamotomy in Parkinson's disease. Journal of neurosurgery, 136(3), pp.681-688.

    Prospective study N=9 PD participants treated with MRgFUS, 12-month follow-up

    The present study investigated the impact of MRgFUS ventral intermediate nucleus thalamotomy on spontaneous neural activity in medication-refractory tremor-dominant PD. The visual area is relevant to tremor improvement in PD after MRgFUS thalamotomy, suggesting a distant effect of MRgFUS thalamotomy and the involvement of specific visuomotor networks in tremor control in PD.

    More comprehensive studies added to evidence summary.

    Zaaroor, M., Sinai, A., Goldsher, et al. (2017). Magnetic resonance–guided focused ultrasound thalamotomy for tremor: a report of 30 Parkinson's disease and essential tremor cases. Journal of neurosurgery, 128(1), 202-210.

    Case series

    N=30 (18 ET, 9 PD and 3 ET-PD)

    MRgFUS VIM thalamotomy to relieve medication-resistant tremor was safe and effective in patients with ET, PD, and ET-PD but large randomised controlled trials are needed to assess longer term efficacy and safety.

    More comprehensive studies added to evidence summary. Not all patients had PD, some had ET.