A prospective trial of magnetic resonance–guided focused ultrasound thalamotomy for essential tremor: Results at the 2‐year follow‐up
Open accessAbstract
Objective: Magnetic resonance guided focused ultrasound (MRgFUS) has recently been investigated as a new treatment modality for essential tremor (ET), but the durability of the procedure has not yet been evaluated. This study reports results at a 2‐ year follow‐up after MRgFUS thalamotomy for ET. Methods: A total of 76 patients with moderate‐to‐severe ET, who had not responded to at least two trials of medical therapy, were enrolled in the original randomized study of unilateral thalamotomy and evaluated using the clinical rating scale for tremor. Sixty‐seven of the patients continued in the open‐label extension phase of the study with monitoring for 2 years. Nine patients were excluded by 2 years, for example, because of alternative therapy such as deep brain stimulation (n = 3) or inadequate thermal lesioning (n = 1). However, all patients in each follow‐up period were analyzed. Results: Mean hand tremor score at baseline (19.8 ± 4.9; 76 patients) improved by 55% at 6 months (8.6 ± 4.5; 75 patients). The improvement in tremor score from baseline was durable at 1 year (53%; 8.9 ± 4.8; 70 patients) and at 2 years (56%; 8.8 ± 5.0; 67 patients). Similarly, the disability score at baseline (16.4 ± 4.5; 76 patients) improved by 64% at 6 months (5.4 ± 4.7; 75 patients). This improvement was also sustained at 1 year (5.4 ± 5.3; 70 patients) and at 2 years (6.5 ± 5.0; 67 patients). Paresthesias and gait disturbances were the most common adverse effects at 1 year—each observed in 10 patients with an additional 5 patients experiencing neurological adverse effects. None of the adverse events worsened over the period of follow‐up, and 2 of these resolved. There were no new delayed complications at 2 years. Interpretation: Tremor suppression after MRgFUS thalamotomy for ET is stably maintained at 2 years. Latent or delayed complications do not develop after treatment. Ann Neurol 2018;83:107–114
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High-intensity focused ultrasound reduces tremor by 55% after 6 months in medically refractory essential tremor.
“A recent study supports that this noninvasive procedure reduces tremor by 55% after 6 months (40).”
From A Review on Wearable Technologies for Tremor Suppression (2021) · cites this paper as [40]
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A Randomized Trial of Focused Ultrasound Thalamotomy for Essential Tremor
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“A prospective, multicenter, randomized trial demonstrated the results 1 year after MRgFUS thalamotomy for ET.(17) In the present study, the durability of tremor relief in patients followed for 2 years after MRgFUS thalamotomy was evaluated to confirm the durability of efficacy and safety of MRgFUS thalamotomy for the…”
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“The first is an open-labeled, uncontrolled pilot trial by Elias et al.(30) The study was conducted on 15 ET patients.”
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“Several successful clinical trials in the treatment of Essential Tremor have been performed using the ExAblate Neuro 4000 system, which have demonstrated both the efficacy and safety of MRgFUS in the treatment of medically refractory essential tremor [1,3,16,17].”
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“Notably, our longterm tremor outcomes are slightly better than what is currently reported in the literature (3, 4, 15).”
ResultSelf-citationFocused Ultrasound and Other Lesioning Therapies in Movement Disorders
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Focused ultrasound and other lesioning in the treatment of tremor.
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Self-citationEssential Tremor - a cerebellar driven disorder?
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“These fi ndings are in agreement with the improvements observed by certain research groups, 4,19,30,31 although others reported lower ef fi cacy.”
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“Serious, persistent, or delayed adverse events including large hematoma have not been reported (6-9).”
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“…Four of the included studies were prospective reports on the follow-up of patients from the randomized controlled trial (RCT) cohort in Elias et al. 16,22 – 25 This RCT is separated in meta-analysis plots into patients who were initially randomized to receive the procedure ( “ Thalamotomy ” ),…”
Wu, P., Lin, W., Li, K.-H., Lai, H., Lee, M.-T., Tsai, K. W., Chiu, P.-Y., Chang, W.-C., Wei, C.-Y., & Taira, T. (2021) · Frontiers in Aging Neuroscience · doi:10.3389/fnagi.2021.697029 · Cited by 17 · see citing works
Self-citationSaluja, S., Barbosa, D. A. N., Parker, J., Huang, Y. (., Jensen, M. R., Ngo, V., Santini, V., Pauly, K., Ghanouni, P., McNab, J., et al. (2020) · Frontiers in Human Neuroscience · doi:10.3389/fnhum.2020.00191 · Cited by 17 · see citing works
“In a 2-year follow up study, however, 4% of the original cohort subsequently received DBS due to unsuccessful or suboptimal treatment with MRgFUS (Chang et al., 2018).”
BackgroundSelf-citationSammartino, F., Snell, J., Eames, M. D. C., & Krishna, V. (2021) · Neurosurgery · doi:10.1093/neuros/nyab238 · Cited by 16 · see citing works
Yang, A. I., Chaibainou, H., Wang, S.-M., Hitti, F. L., Mcshane, B., Tilden, D., Korn, M., Blanke, A., Dayan, M., Wolf, R., et al. (2019) · Operative Neurosurgery · doi:10.1093/ons/opz013 · Cited by 16 · see citing works
High Intensity Focused Ultrasound – Longitudinal Data on Efficacy and Safety
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“Unilateral MRgFUS thalamotomy using the ExAblate 4000 has been described previously in detail [5, 32, 33].”
Maesawa, S., Nakatsubo, D., Tsugawa, T., Kato, S., Shibata, M., Takai, S., Torii, J., Ishizaki, T., Wakabayashi, T., & Saito, R. (2021) · Neurologia medico-chirurgica · doi:10.2176/nmc.ra.2021-0187 · Cited by 15 · see citing works
Magnetic resonance-guided focused ultrasound for the treatment of tremor
Yamamoto, K., Sarica, C., Loh, A., Vetkas, A., Samuel, N., Milano, V., Zemmar, A., Germann, J., Cheyuo, C., Boutet, A., et al. (2022) · Expert Review of Neurotherapeutics · doi:10.1080/14737175.2022.2147826 · Cited by 14 · see citing works
Self-citationCoherent Structural and Functional Network Changes after Thalamic Lesions in Essential Tremor
Pohl, E. D. R., Upadhyay, N., Kobeleva, X., Purrer, V., Maurer, A., Keil, V. C., Kindler, C., Borger, V., Pieper, C., Groetz, S. F., et al. (2022) · Movement Disorders · doi:10.1002/mds.29130 · Cited by 14 · see citing works
“ies have shown long-term tremor suppression and qualityof-life improvements similar to DBS.(7-10) ET is considered to result from neuronal oscillations,(11-13) and the “oscillating network hypothesis”(13)”
BackgroundInfluentialWang, X., Xiong, Y.-Q., Lin, J.-J., & Lou, X. (2022) · Journal of Magnetic Resonance Imaging · doi:10.1002/jmri.28080 · Cited by 14 · see citing works
“Vim is the most common nucleus targeted within the motor thalamus(38) that receives the vestibular and proprioceptive muscle spindle afferent inputs.(39,40) The traditional anatomical coordinates of Vim are at 25% of the anterior and posterior commissure (AC-PC) distance anterior to the PC and 14 mm lateral to the AC-…”
BackgroundLongitudinal analysis of structural changes following unilateral focused ultrasound thalamotomy
Sammartino, F., Yeh, F.-C., & Krishna, V. (2019) · NeuroImage: Clinical · doi:10.1016/j.nicl.2019.101754 · Cited by 14 · see citing works
“Contralateral hand tremor after FUS-T improves by approximately 50% (clinical rating scale for tremor [CRST]), and the results are sustained up to 24months (Chang et al., 2018).”
Consensus Statement on High-Intensity Focused Ultrasound for Functional Neurosurgery in Switzerland
Stieglitz, L., Oertel, M., Accolla, E., Bally, J. F., Bauer, R., Baumann, C., Benninger, D., Bohlhalter, S., Büchele, F., Hägele-Link, S., et al. (2021) · Frontiers in Neurology · doi:10.3389/fneur.2021.722762 · Cited by 13 · see citing works
Moosa, S., Craver, A., Asuzu, D. T., Eames, M. D. C., Wang, T. R., & Elias, W. (2022) · Stereotactic and Functional Neurosurgery · doi:10.1159/000525763 · Cited by 12 · see citing works
Self-citationFocused ultrasound: growth potential and future directions in neurosurgery
Zhang, M., Rodrigues, A. J., Zhou, Q., & Li, G. (2021) · Journal of Neuro-Oncology · doi:10.1007/s11060-021-03820-9 · Cited by 15 · see citing works
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“Chang et al. 4) reported a prospective study for 2-year outcomes after MRgFUS thalamotomy in 67 patients, with a 56% improvement in the CRST score.”
Thaler, C. P., Tian, Q., Wintermark, M., Ghanouni, P., Halpern, C. H., Henderson, J. M., Airan, R. D., Zeineh, M., Goubran, M., Leuze, C. W., et al. (2022) · Brain Connectivity · doi:10.1089/brain.2021.0157 · Cited by 13 · see citing works
“…recently been introduced as a new and less invasive treatment option to provide substantial and stable relief in patients with severe or medication-refractory essential tremor (ET) (Chang et al., 2018; Elias et al., 2013, 2016; Lipsman et al., 2013; Ravi-kumar et al., 2017; Zaaroor et al., 2017).”
Self-citationReich, S. (2019) · The Medical clinics of North America · doi:10.1016/j.mcna.2018.10.016 · Cited by 11 · see citing works
Mortezaei, A., Essibayi, M., Eraghi, M. M., Alizadeh, M., Taghlabi, K. M., Eskandar, E. N., & Faraji, A. (2024) · Neurosurgical Focus · doi:10.3171/2024.6.focus24326 · Cited by 10 · see citing works
Gautam, D., Venkatraman, V., Horns, J. J., Yang, L., Lee, H.-J., Kassavetis, P., Alshaikh, J. T., Moretti, P., Shofty, B., & Rahimpour, S. (2024) · BMJ Neurology Open · doi:10.1136/bmjno-2023-000582 · Cited by 10 · see citing works
“…ablative option for patients who may otherwise be poor surgical candidates for DBS or who are unwilling to undergo an invasive procedure 19 ; however, studies evaluating the demographics of the population of patients receiving MRgFUS and trends in DBS surgery after the introduction of…”
Kindler, C., Upadhyay, N., Purrer, V., Schmeel, F. C., Borger, V., Scheef, L., Wüllner, U., & Boecker, H. (2023) · Parkinsonism & Related Disorders · doi:10.1016/j.parkreldis.2023.105845 · Cited by 10 · see citing works
Essential Tremor—Do We Have Better Therapeutics? A Review of Recent Advances and Future Directions
Shetty, N. (2022) · Current Neurology and Neuroscience Reports · doi:10.1007/s11910-022-01185-8 · Cited by 10 · see citing works
Intraoperative lesion characterization after focused ultrasound thalamotomy.
Sammartino, F., Yeh, F.-C., & Krishna, V. (2021) · Journal of Neurosurgery · doi:10.3171/2021.10.jns211651 · Cited by 10 · see citing works
Deep brain stimulation and other surgical modalities for the management of essential tremor
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Valentino, F., Cosentino, G., Maugeri, R., Giammalva, R., Iacopino, G., Marrale, M., Bartolotta, T., & Gagliardo, C. (2019) · Operative Neurosurgery · doi:10.1093/ons/opz300 · Cited by 10 · see citing works
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Does This Patient Have Parkinson Disease or Essential Tremor?
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Diffusion imaging changes in the treated tract following focused ultrasound thalamotomy for tremor
Mazerolle, E. L., Warwaruk-Rogers, R., Romo, P., Sankar, T., Scott, S., Rockel, C., Pichardo, S., Martino, D., Kiss, Z., & Pike, G. (2021) · Neuroimage: Reports · doi:10.1016/j.ynirp.2021.100010 · Cited by 8 · see citing works
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The Emerging Role of Magnetic Resonance Imaging-Guided Focused Ultrasound in Functional Neurosurgery
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Magnetic Resonance–Guided Focused Ultrasound
Napoli, A., & Cartocci, G. (2016) · doi:10.1201/b19531-21 · Cited by 8
Quantitative Tractography‐Based Evaluations in Essential Tremor Patients after MRgFUS Thalamotomy
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A Comprehensive Narrative Review of Neuropathic Pain: From Pathophysiology to Surgical Treatment
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“In a multicenter clinical study, the efficacy of MRgFUS in treating tremor was evaluated and revealed a promising improvement rate of 55% on the clinical rating scale of tremor (CRST) at six months post-treatment, with sustained improvement of 56% observed after two years [35].”
MethodEvaluation of Cerebral Volume Changes in Patients with Tremor Treated by MRgFUS Thalamotomy
Bruno, F., Tommasino, E., Catalucci, A., Pastorelli, C., Borea, F., Caldarelli, G., Bellini, M., Badini, P., Mancini, S., Santobuono, C., et al. (2022) · Life · doi:10.3390/life13010016 · Cited by 7
“Transcranial thalamotomy of Vim using magnetic resonance guided high-intensity focused ultrasound (tc-MRgFUS) is a new minimally invasive thermal ablation procedure that does not require surgical access and represents a safe and effective treatment option for tremor in patients with ET and PD [6,7].”
BackgroundMethodPae, C., Kim, M., Chang, W., Jung, H., Chang, K., Eo, J., Park, H.-J., & Chang, J. W. (2022) · Journal of Neurosurgery · doi:10.3171/2022.5.jns22324 · Cited by 7 · see citing works
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Recent advances in understanding and managing dystonia
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Metta, V., Benamer, H. T. S., Kapsas, G., Mridula, R., Alugolu, R., Hussain, H., Nalarakettil, A., Sai, S., Elmahdy, M., Borgohain, R., et al. (2025) · Journal of Movement Disorders · doi:10.14802/jmd.25042 · Cited by 6 · see citing works
“A follow-up study by Chang et al. 28 involving 67 patients treated with MRgFUS over 2 years revealed sustained improvements, with 55% reduction in contralateral hand tremor scores at 6 months, 53% at 1 year, and 56% at 2 years, indicating that the treatment response remained remarkably stable.”
Zhang, L.-L., Cui, S., Xi, X., Bi, H., & Huang, B. (2024) · Frontiers in Aging Neuroscience · doi:10.3389/fnagi.2024.1380851 · Cited by 6 · see citing works
- Authors
- Chang, J. W., Park, C. K., Lipsman, N., Schwartz, M. L., Ghanouni, P., Henderson, J. M., Gwinn, R., Witt, J., Tierney, T. S., Cosgrove, G. R., Shah, B. B., Abe, K., Taira, T., Lozano, A. M., Eisenberg, H. M., Fishman, P. S., & Elias, W. J.
- Affiliations
- Yonsei University (KR)
- Sunnybrook Health Science Centre (CA)
- Stanford Medicine (US)
- Swedish Medical Center (US)
- University of Miami (US)
- Brigham and Women's Hospital (US)
- University of Virginia Health System (US)
- Tokyo Women's Medical University (JP)
- Department of Neurosurgery University of Toronto Toronto Ontario Canada
- Departments of Neurosurgery
- University of Maryland, Baltimore (US)
- Corresponding author
- Chang, Jin Woo
- ORCID
- Venue
- Annals of Neurology
- Publisher
- Wiley
- Published
- 2018-01
- Volume
- 83
- Issue
- 1
- Pages
- 107-114
- ISSN
- 0364-5134 (ISSN-L)
- 1531-8249
- OpenAlex
- W2781303375
- Cited by
- 178
- References
- 30
- Citations by year
- 2026: 17 · 2025: 20 · 2024: 23 · 2023: 13 · 2022: 25 · 2021: 20 · 2020: 23 · 2019: 29 · 2018: 7
- FWCI
- 11.24
- Type
- journal article
- Language
- en
- Open access
- Licence
- Locations
- Annals of Neurology (publishedVersion)
- PubMed (publishedVersion)
- YUHSpace (Yonsei University Medical Library) (submittedVersion, cc-by-nc-nd)
- Funders
- InSightec (Haifa, Israel) the Focused Ultrasound Foundation
- Binational Industrial Research and Development (BIRD) Foundation
- Topics
- Health Sciences › Medicine › Neurology › Neurological disorders and treatments
- Physical Sciences › Engineering › Biomedical Engineering › Ultrasound and Hyperthermia Applications
- Social Sciences › Psychology › Clinical Psychology › Obsessive-Compulsive Spectrum Disorders
- Keywords
- essential tremor, MR-guided focused ultrasound, thalamotomy, treatment durability, hand tremor, disability, adverse effects, paresthesia, gait disturbance, long-term follow-up
- MeSH terms
- Aged, Aged, 80 and over, Disability Evaluation, Female, Follow-Up Studies, Hand, Humans, Magnetic Resonance Imaging, Male, Middle Aged, Paresthesia, Posture, Prospective Studies, Thalamus, Treatment Outcome, Ultrasonography, Interventional, Neurosurgical Procedures, Gait Disorders, Neurologic, Essential Tremor, Surgery, Computer-Assisted
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