NCT03253991

A Study to Evaluate the Effectiveness and Safety of ExAblate MRgFUS on Essential Tremor

A Study to Evaluate the Effectiveness and Safety of ExAblate Transcranial MRgFUS Thalamotomy Treatment of Medication Refractory Essential Tremor Subjects

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 154 (actual)
• Sponsor: InSightec · Industry
• Sex: All
• Age: 22 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

A Study to Evaluate the Effectiveness and Safety of ExAblate Transcranial MRgFUS Thalamotomy Treatment of Medication Refractory Essential Tremor Subjects The objective of this prospective, single-arm study is to test the efficacy of treatment using the ExAblate Transcranial System and to further demonstrate safety in medication-refractory tremor inpatients with essential tremor (ET). The Indications for Use claim for this system is as follows: Treatment of medication-refractory tremor in patients with essential tremor.

Detailed description

The objective of this prospective, multi-site, single-arm study is to test the efficacy of treatment using the ExAblate Transcranial System and to further demonstrate safety in medication-refractory tremor in subjects with essential tremor (ET). Safety: To evaluate the incidence and severity of adverse events (AE/AEs) associated with ExAblate Transcranial MRgFUS treatment of medication-refractory ET Effectiveness: To determine the effectiveness of the ExAblate Transcranial MRgFUS treatment of medication-refractory tremor (i.e. ET). Efficacy will be determined utilizing the Clinical Rating Scale for Tremor (CRST) in ET from examinations at baseline and 3-Months post-ExAblate treatment. • This study is designed as a prospective, multi-site, single-arm study. Assessments of primary efficacy endpoints will compare the three months after ExAblate treatment to Baseline measurements for clinical symptom relief. Safety of ExAblate in the treatment of ET will be collected for one year after ExAblate treatment. Relative Safety will be evaluated using a common description of Significant Clinical Complications for patients treated in this study. This study will be performed on the 3T MR scanners. The secondary endpoints of the study are as follows: 1. Quality life claims: Questionnaire for Essential Tremor (QUEST) outcome (upper extremity questions) at Months 3 change from Baseline 2. Durability (as measured by QUEST upper arm extremity questions) of the procedure as reflected by the efficacy data through change from baseline measures through Month 12 follow up 3. Subject daily functionalities: as measured by CRST Part-C (subscales)Month 12 as compared to Baseline.

Conditions

• Essential Tremor

Interventions

Type	Name	Description
DEVICE	MRgFUS treatment	ExAblate Transcranial MRgFUS Thalamotomy Treatment of Medication Refractory Essential Tremor Subjects

Timeline

• Start date: 2014-11-17
• Primary completion: 2023-02-02
• Completion: 2023-02-02
• First posted: 2017-08-18
• Last updated: 2023-04-20

Locations

11 sites across 3 countries: China, Japan, Taiwan