Clinical Trials Directory

Trials / Completed

CompletedNCT03300193

The Effect of Lesion Characteristics in MRgFUS on Tremor in Essential Tremor and Parkinson's Disease

The Effect of Lesion Characteristics in Magnetic Resonance Guided Focused Ultrasound Surgery (MRgFUS) on Tremor in Essential Tremor and Parkinson's Disease

Status
Completed
Phase
Study type
Observational
Enrollment
23 (actual)
Sponsor
Rambam Health Care Campus · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Accepted

Summary

The study will investigate Essential Tremor and Parkinson's Disease patients who underwent Magnetic Resonance guided Focused Ultrasound Surgery (MRgFUS). We will evaluate the effect of lesion characteristics on tremor and on quality of life after the procedure as compared with the baseline prior to the procedure.

Detailed description

The purpose of the study is to investigate the effect of lesion characteristics in ExAblate Transcranial Magnetic Resonance guided Focused Ultrasound Surgery (MRgFUS) of the Vim thalamic nucleus. Clinical measures will be used to study patients suffering from medication-refractory tremor, Essential Tremor or idiopathic Parkinson's Disease. This study is designed as a prospective, observational, and clinical study. Assessments will be made before and after MRgFUS for; clinical tremor relief, quality of life (QoL) improvements, assessment of adverse events, and correlations of these measures with the size and shape of the lesion and the surrounding edema .

Conditions

Timeline

Start date
2016-05-01
Primary completion
2017-05-31
Completion
2017-05-31
First posted
2017-10-03
Last updated
2017-10-03

Source: ClinicalTrials.gov record NCT03300193. Inclusion in this directory is not an endorsement.

The Effect of Lesion Characteristics in MRgFUS on Tremor in Essential Tremor and Parkinson's Disease (NCT03300193) · Clinical Trials Directory