Magnetic Resonance-guided Focused Ultrasound Surgery (MRgFUS) is a noninvasive thermal ablation method, consistingof high intensity focused ultrasound energy and an MR scan for anatomical imaging and real-time thermal mapping.Thanks to novel technology today is possible to create a sharp focal point in the planned target through the intact skull forthe treatment of neurological disorders. Preliminary results in patients with essential tremor (ET) and tremor-dominantParkinson have been published with systems operating with 3T MR scanners. This clinical trial aims to evaluate the safetyand effectiveness of transcranial MRgFUS (tcMRgFUS) treatments performed using a 1.5T MR unit in patients with ET thatcannot be controlled by medications. Secondary aims are to evaluate post-thalamotomy brain connectivity changes by theuse of advanced neuroimaging techniques which nowadays are increasingly used to investigate noninvasively brain neuralnetworks and to perform a cost analysis.
Specific Aim 1:TcMRgFUS clinical trial for 30 eligible patients with medication refractory ET.The safety and efficacy of such experimentalnon-invasive treatment will be investigated during a 2y follow-up period. Safety will be measured by the severity andincidence of treatment-related adverse events during treatment and throughout follow-ups.Technical effectiveness will bemeasured by lesion accuracy on MRI images acquired after treatment (obtained post-treatment non-perfused volume sizeand location vs. atlas and prescribed target based on functional response of the patients to sublethal energies prior toactual lesioning);clinical effectiveness will be measured by the change from baseline in Clinical Rating Score for Tremor(CRST) and Quality of Life in Essential Tremor Questionnaire (QUEST) scores.Specific Aim 2:The investigation of structural and functional connectivity changes after tcMRgFUS treatments during the 2 years follow-upperiod will be performed by using diffusion weighted imaging (DWI) and RS-fMRI respectively.Specific Aim 3:Costs of tcMRgFUS for health systems have not yet been evaluated. Alternative treatment options for ET are Deep BrainStimulation (DBS), stereotactic radiofrequency ablation and radiosurgery.A cost analysis from U.S. reports an average costof DBS of USD39,152).In a Swedish Health Technology Assessment report cost per patient diagnosed with ET andtreated with DBS result SEK170,000 (about EUR18,000) while tcMRgFUS is estimated SEK48,000 (aboutEUR5,000).In Italy, DRG tariffs for alternative treatments of ET cover up to EUR16,000.Our project also aims toestimate health benefits and resources consumption associated with tcMRgFUS, specifically in Italy (as was already madefor MRgFUS treatments in uterine fibroids).
|Effective start/end date||6/1/18 → 5/31/21|