Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2026-01-24 @ 9:52 PM
Study NCT ID:
NCT03300193
Status:
COMPLETED
Last Update Posted:
2017-10-03
First Post:
2016-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Lesion Characteristics in MRgFUS on Tremor in Essential Tremor and Parkinson's Disease
Sponsor:
Rambam Health Care Campus
Organization:
Study Overview
Official Title:
The Effect of Lesion Characteristics in Magnetic Resonance Guided Focused Ultrasound Surgery (MRgFUS) on Tremor in Essential Tremor and Parkinson's Disease
Status:
COMPLETED
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MRgFUS
Brief 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 .
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 .
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: