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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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“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
Elias, W. J., Lipsman, N., Ondo, W. G., Ghanouni, P., Kim, Y. G., Lee, W., Schwartz, M., Hynynen, K., Lozano, A. M., Shah, B. B., et al. (2016) · New England Journal of Medicine · doi:10.1056/nejmoa1600159 · Cited by 1,167 · cited 6×
“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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“Medical management, typically with propranolol or primidone, is generally initiated when the tremor begins to interfere with the patient’s ability to undertake daily activities, but the effectiveness of drugs for this disorder is limited.(3,4) Surgery can be considered for patients with disabling, medication-resistant…”
BackgroundA pilot study of focused ultrasound thalamotomy for essential tremor.
Elias, W., Huss, D., Voss, T., Loomba, J., Khaled, M., Zadicario, E., Frysinger, R. C., Sperling, S., Wylie, S., Monteith, S., et al. (2013) · New England Journal of Medicine · doi:10.1056/nejmoa1300962 · Cited by 833 · cited 2×
“The first is an open-labeled, uncontrolled pilot trial by Elias et al.(30) The study was conducted on 15 ET patients.”
BackgroundSelf-citationMR-guided focused ultrasound thalamotomy for essential tremor: a proof-of-concept study
Lipsman, N., Schwartz, M. L., Huang, Y., Lee, L., Sankar, T., Chapman, M., Hynynen, K., & Lozano, A. M. (2013) · The Lancet Neurology · doi:10.1016/s1474-4422(13)70048-6 · Cited by 604 · cited 2×
“The second study was conducted by Lipsman et al and similarly investigated the use of MRgFUS thalamotomy to treat 4 patients with medically refractive ET.(19) Then, Chang et al reported the outcome of MRgFUS thalamotomy in 11 patients with medication-resistant ET.”
BackgroundMethodSelf-citationLouis, E. D., Ottman, R., & Allen Hauser, W. (1998) · Movement Disorders · doi:10.1002/mds.870130105 · Cited by 424 · cited 9×
“VC 2017 American Neurological Association 107 Essential tremor (ET) is one of the most common neu-rological disorders, with a prevalence of 4.6% in people aged 65 years.1 Community-based studies have reported at least mild functional impairment in 60% of patients with ET.1,2 Medical management, typically with proprano…”
BackgroundInfluentialLong‐term efficacy of thalamic deep brain stimulation for tremor: Double‐blind assessments
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“However, Chang et al reported that the size of the lesion and degree of symptom improvement were not directly correlated in MRgFUS treatment.(16) These results, which show that the benefit of various treatments for ET can decrease over time, highlight the need for long-term evaluation of the effect of MRgFUS thalamoto…”
BackgroundResultInfluentialSelf-citationLong-term follow-up results of selective VIM-thalamotomy.
Nagaseki, Y., Shibazaki, T., Hirai, T., Kawashima, Y., Hirato, M., Wada, H., Miyazaki, M., & Ohye, C. (1986) · Journal of Neurosurgery · doi:10.3171/jns.1986.65.3.0296 · Cited by 208 · cited 1×
“Stereotactic radiofrequency (RF) thalamotomy and deep brain stimulation (DBS), targeted to the ventralis intermedius nucleus of the thalamus (Vim), have proven effective for treating ET and other tremors.(6,7) These interventions, although highly effective, have risks associated with an open neurosurgical operation, i…”
BackgroundLong‐term follow‐up of thalamic stimulation versus thalamotomy for tremor suppression
Schuurman, P., Bosch, D. A., Merkus, M., & Speelman, J. (2008) · Movement Disorders · doi:10.1002/mds.22059 · Cited by 206 · cited 3×
“Stereotactic radiofrequency (RF) thalamotomy and deep brain stimulation (DBS), targeted to the ventralis intermedius nucleus of the thalamus (Vim), have proven effective for treating ET and other tremors.(6,7) These interventions, although highly effective, have risks associated with an open neurosurgical operation, i…”
Background
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“Effects at 2 years [31, 178] and up to 4 years [179] have been reported.”
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ResultSelf-citationPredictors of Outcomes After Focused Ultrasound Thalamotomy.
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Self-citationIs MR-guided High-intensity Focused Ultrasound a Feasible Treatment Modality for Desmoid Tumors?
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Self-citationTreatment of essential tremor: current status
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BackgroundSelf-citationSurgical treatments for essential tremor
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“Sixty seven of 76 patients in a randomized controlled trial of FUS thalamotomy [46] completed a 2-year open-label followup with blinded video exams [75].”
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“safely ablate deep brain regions involved in neurological diseases, such as essential tremor [1]–[3], Parkinsonian tremor [4] or obsessive compulsive disorders [5].”
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“This would be another barrier for finding the optimal MRgFUS thalamotomy candidates for pa- tients with ET.”
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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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“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 ” ),…”
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“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).”
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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].”
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Magnetic resonance-guided focused ultrasound for the treatment of tremor
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Self-citationCoherent Structural and Functional Network Changes after Thalamic Lesions in Essential Tremor
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“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
“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
“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
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
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
Hashida, M., Maesawa, S., Kato, S., Nakatsubo, D., Tsugawa, T., Torii, J., Tanei, T., Ishizaki, T., Mutoh, M., Ito, Y., et al. (2024) · Neurologia medico-chirurgica · doi:10.2176/jns-nmc.2023-0202 · Cited by 11
“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
“…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
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
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
“…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
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
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
Deep brain stimulation and other surgical modalities for the management of essential tremor
Wang, K., Ren, Q.-W., Chiu, S. Y., Patel, B., Meng, F.-G., Hu, W., & Shukla, A. (2020) · Expert Review of Medical Devices · doi:10.1080/17434440.2020.1806709 · Cited by 10
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
Kain, K., Peters, J., Jonker, B., Barnett, Y., Maamary, J., Barnett, M., Maller, J., Wang, C.-Y., & Tisch, S. (2024) · Movement Disorders Clinical Practice · doi:10.1002/mdc3.14005 · Cited by 9
Kain, K., Maamary, J., Jonker, B., Peters, J., Barnett, Y., Barnett, M., D'Souza, A., Maller, J., Wang, C.-Y., & Tisch, S. (2023) · Journal of Neurosurgery · doi:10.3171/2023.6.jns231153 · Cited by 9
Does This Patient Have Parkinson Disease or Essential Tremor?
Reich, S. (2020) · Clinics in Geriatric Medicine · doi:10.1016/j.cger.2019.09.015 · Cited by 9
Zhang, D. Y., Pearce, J. J., Mazza, J. M., Petrosyan, E., Borghei, A., Patel, N., & Sani, S. B. (2023) · Stereotactic and Functional Neurosurgery · doi:10.1159/000528925 · Cited by 8
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
Gagliardo, C., Cannella, R., Filorizzo, G., Toia, P., Salvaggio, G., Collura, G., Pignolo, A., Maugeri, R., Napoli, A., D'Amelio, M., et al. (2021) · Scientific Reports · doi:10.1038/s41598-021-82271-8 · Cited by 8
Gagliardo, C., Cannella, R., D'angelo, C., Toia, P., Salvaggio, G., Feraco, P., Marrale, M., Iacopino, D., D'Amelio, M., Tona, G. L., et al. (2021) · Brain Science · doi:10.3390/brainsci11010046 · Cited by 8
The Emerging Role of Magnetic Resonance Imaging-Guided Focused Ultrasound in Functional Neurosurgery
Fiani, B., Lissak, I. A., Soula, M., Sarhadi, K. J., Shaikh, E. S., Baig, A., Farooqui, M., & Quadri, S. A. (2020) · Cureus · doi:10.7759/cureus.9820 · Cited by 11
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
Ghielmetti, F., Aquino, D., Andreasi, N. G., Mazzi, F., Greco, E., Cilia, R., de Martin, E., Rinaldo, S., Stanziano, M., Levi, V., et al. (2024) · Movement Disorders Clinical Practice · doi:10.1002/mdc3.14219 · Cited by 7
Chua, M. M. J., LeBlang, S., Powlovich, L., Gilbertson, T., Krishna, V., Guttmann, C. R. G., Eames, M. D. C., Poulsen, F., & Cosgrove, G. R. (2024) · Neurosurgical Focus · doi:10.3171/2024.6.focus2494 · Cited by 7
Self-citationNishida, N., Sugita, Y., Sawada, M., Ishimori, T., Taruno, Y., Otsuki, K., Motoie, R., Kitamura, K., Yoshizaki, W., Kasashima, K., et al. (2024) · Neurosurgical Focus · doi:10.3171/2024.6.focus24330 · Cited by 7
A Comprehensive Narrative Review of Neuropathic Pain: From Pathophysiology to Surgical Treatment
Pessôa, B. L., Hauwanga, W. N., Thomas, A., Valentim, G., & McBenedict, B. (2024) · Cureus · doi:10.7759/cureus.58025 · Cited by 7
“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
Self-citationMensah-Brown, K., Yang, A. I., Hitti, F. L., Henry, L., Heman-Ackah, S., Chaibainou, H., & Baltuch, G. (2022) · Operative Neurosurgery · doi:10.1227/ons.0000000000000119 · Cited by 7
Recent advances in understanding and managing dystonia
Tisch, S. (2018) · F1000Research · doi:10.12688/f1000research.13823.1 · Cited by 7
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
“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
Metadata
- 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 › Clinical Neurology › Deep Brain Stimulation and Movement Disorders
- 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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