Interventional procedure overview of MRI-guided focused ultrasound thalamotomy for treating moderate to severe tremor in Parkinson's
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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.
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 Ultrasound, 2, 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 Movements, 7. | 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. |
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