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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.

Authors: Iacopino DG, Gagliardo C, Giugno A, Giammalva GR, Napoli A, Maugeri R, Graziano F, Valentino F, Cosentino G, D'Amelio M, Bartolotta TV, Catalano C, Fierro B, Midiri M, Lagalla R

OBJECTIVE Transcranial magnetic resonance-guided focused ultrasound surgery (tcMRgFUS) is one of the emerging noninvasive technologies for the treatment of neurological disorders such as essential tremor (ET), idiopathic asymmetrical tremor-dominant Parkinson's disease (PD), and neuropathic pain. In this clinical series the authors present the preliminary results achieved with the world's first tcMRgFUS system integrated with a 1.5-T MRI unit. METHODS The authors describe the results of tcMRgFUS in a sample of patients with ET and with PD who underwent the procedure during the period from January 2015 to September 2017. A monolateral ventralis intermedius nucleus (VIM) thalamic ablation was performed in both ET and PD patients. In all the tcMRgFUS treatments, a 1.5-T MRI scanner was used for both planning and monitoring the procedure. RESULTS During the study period, a total of 26 patients underwent tcMRgFUS thalamic ablation for different movement disorders. Among these patients, 18 were diagnosed with ET and 4 were affected by PD. All patients with PD were treated using tcMRgFUS thalamic ablation and all completed the procedure. Among the 18 patients with ET, 13 successfully underwent tcMRgFUS, 4 aborted the procedure during ultrasound delivery, and 1 did not undergo the tcMRgFUS procedure after stereotactic frame placement. Two patients with ET were not included in the results because of the short follow-up duration at the time of this study. A monolateral VIM thalamic ablation in both ET and PD patients was performed. All the enrolled patients were evaluated before the treatment and 2 days after, with a clinical control of the treatment effectiveness using the graphic items of the Fahn-Tolosa-Marin tremor rating scale. A global reevaluation was performed 3 months (17/22 patients) and 6 months (11/22 patients) after the treatment; the reevaluation consisted of clinical questionnaires, neurological tests, and video recordings of the tests. All the ET and PD treated patients who completed the procedure showed an immediate amelioration of tremor severity, with no intra- or posttreatment severe permanent side effects. CONCLUSIONS Although this study reports on a small number of patients with a short follow-up duration, the tcMRgFUS 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. To the best of the authors' knowledge, this is the first clinical series in which thalamotomy was performed using tcMRgFUS integrated with a 1.5-T magnet.

Introduction

Purpose Thermal ablation
Study Objective To report preliminary experience evaluating the feasibility and safety of a transcranial MR-guided focused ultrasound system integrated with a 1.5-T MRI in patients with essential tremor and Parkinson's disease.
Animal model / Human subject Homo sapiens; strain: N/A; age: not specified; sex: not specified
Disease model Essential tremor, Parkinson's disease
MRI or image guidance method Magnetic resonance-guided (integrated with a 1.5-T MRI unit)
Targeted brain region(s) Thalamus

Outcomes and Safety

Summary of Outcomes Transcranial MR‑guided focused ultrasound integrated with a 1.5‑T MRI produced preliminary reduction of tremor and improvement in motor symptoms in patients with essential tremor and Parkinson's disease. The report does not specify or compare multiple focused ultrasound parameter sets, so no particular parameters are identified as successful.
Safety-related matter The provided text consists only of the article title and contains no mention of safety assessments, adverse effects, or complications. No information on adverse events was reported in the text provided.

Brain Region

Ultrasound Parameters

Focal Characteristics Focal depth: None; Focal length: None; Aperture size: None

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