Original Title: Ultrasonido focalizado de alta intensidad (HIFU) en temblor esencial y Parkinson

Authors' objectives: Update a health technology evaluation report on the use of high-intensity ultrasound for essential tremor and Parkinson disease.

Authors' results and conclusions: This exploratory review indicates that magnetic resonance-guided focused ultrasound (MRIgFUS) may be a promising minimally invasive option for the treatment of essential tremor and Parkinson disease. The studies retrieved are of variable methodological quality, and in some cases, have limitations that compromise their conclusions. In essential tremor, the evidence shows that MRIgFUS reduces tremor severity, improving function and quality of life, and is superior to sham (placebo) surgery. Compared to active alternatives, the effects are similar to radiofrequency thalamotomy and comparable to unilateral deep brain stimulation, and it has a good safety profile, with mainly mild/short-term events (ataxia, araesthesia) that tend to fade with time. In Parkinson disease, evidence suggests that MRIgFUS improves tremor (including dominant/asymmetric tremor) and quality of life with an acceptable safety profile and no significant cognitive impairment in follow-ups of up to 12 months. In comparisons between procedures, bilateral deep brain stimulation is associated with greater decreases in severity, while in unilateral approaches, MRIgFUS may lead to greater improvement in quality of life; however, gait disturbance and other adverse effects have been reported more frequently with MRIgFUS than with DBS. From an economic perspective, a report from Ontario estimates a gain of 3.69 quality-adjusted life years (QALYs) and an incremental cost-effectiveness ratio of approximately $ 43 075 per QALY compared to no surgery in tremor-dominant patients who are not candidates for invasive surgery. In comparisons with deep brain stimulation, a systematic review indicates that MRIgFUS is economically superior, and a cost-modelling meta-analysis indicates that, to be cost-effective compared to bilateral deep brain stimulation, MRIgFUS should achieve improvements in the Unified Parkinson’s Disease Rating Scale scores of 15 % (2 years) and 32.8 % (5 years). Overall, MRIgFUS emerges as an effective and safe technique, with a potentially high cost-effectiveness ratio, especially in patients in whom invasive surgery is contraindicated. Nonetheless, further high-quality studies are required to confirm these findings and assess whether this technology can be used bilaterally. Conclusions MRIgFUS is effective for the treatment of unilateral tremor in patients with essential tremor and Parkinson disease. It improves quality of life and tremor, although it has a weaker effect on tremor severity than deep brain stimulation, and the evidence of these benefits is still of low quality. The technique seems to be associated with improvements in complications such as ataxia, especially when advanced focusing is used, and complications tend to fade over time. This suggests that MRIgFUS may be a valid alternative in patients who are not candidates for invasive procedures. From an economic point of view, the fact that MRIgFUS does not require implantable hardware or intensive postoperative care may compensate for the initial investment required to use this technique. The analyses retrieved in the review seem to indicate its projected costs are lower than those of deep brain stimulation. Nonetheless, for Parkinson disease, bilateral deep brain stimulation currently remains more cost-effective. Although MRIgFUS is a promising technique, high-quality prospective studies are required to directly compare its efficacy and safety with that of deep brain stimulation, to establish its role in the treatment of movement disorders.

Authors' methods: An exploratory review was conducted to identify the evidence available on the technology of interest applied to essential tremor and Parkinson disease, based on recent scientific literature, with particular emphasis on surgical targets (subthalamic nucleus and thalamus), clinical assessment parameters, and safety. The results of clinical studies published are analysed.

Project Status: Completed

Year Published: 2026

URL for published report: https://www.euskadi.eus/contenidos/informacion/osteba_publicacion/eu_def/adjuntos/E-26-07-Ultrasonido_focalizado_de_alta_intensidad.pdf

English language abstract: An English language summary is available

Publication Type: Mini HTA

Country: Spain

Organisation Name: Basque Office for Health Technology Assessment

Contact Address: C/ Donostia – San Sebastián, 1 (Edificio Lakua II, 4ª planta) 01010 Vitoria - Gasteiz

Contact Name: Lorea Galnares-Cordero

Contact Email: lgalnares@bioef.eus

Copyright: <p>Osteba (Basque Office for Health Technology Assessment) Health Department of the Basque Government</p>