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

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

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.

Study Overview

• Status: Completed
• Conditions: Tremor

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 .

• Study Type: Observational
• Enrollment (Actual): 23

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients which were diagnosed with ET or Idiopathic PD with medication refractory tremor that underwent MRgFUS procedure.

Description

Inclusion Criteria:

• Men and women, between 18 and 80 years.
• Patients who underwent the MRgFUS procedure.
• Patients who are able and willing to give consent and able to attend all study visits and Radiologic follow-up examination by MRI.
• A diagnosis of ET or Idiopathic PD as confirmed from clinical history and examination preformed by a movement disorders neurologist.
• ET patients: tremor severity score of greater than or equal to 2 in the treated hand/arm as measured by postural or action item on the Clinical Rating Scale for Tremor (CRST).
• PD patients: tremor severity score of equal or greater than 3 on either item 20 or item 21 of motor part in the Unified PD Rating Scale (UPDRS).
• Substantial disability in the performance of at least two daily activities from the disability subsection of the scales UPDRS for PD patients or CRST for ET patients.
• The patient must have a history of an unsatisfactory response to medical management. All patients will need to have tried and failed at least one drug. Alternatively, a patient may also qualify if tremor-suppressing medications are contraindicated due to a coexisting medical condition or drug allergy.
• Stable doses of all medications for 30 days prior to study entry.

Exclusion Criteria:

• Patients which have not completed the MRgFUS procedure.
• Patients which were diagnosed during the trial with additional diagnoses that can affect motor function, quality of life and symptoms of tremor.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Tremor patients; Essential Tremor and Parkinson's Disease patients with Tremor refractory to pharmacological therapy who underwent Magnetic Resonance guided Focused Ultrasound Surgery (MRgFUS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Rating Scale for Tremor	Tremor score: In ET patients - Clinical Rating Scale for Tremor (CRST)	3 MONTHS
Motor part of Unified PD Rating Scale	In PD patients - Motor part of Unified PD Rating Scale (UPDRS)	3 MONTHS

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life Essential Tremor Questionnaire	Quality of life: Quality of Life Essential Tremor Questionnaire (QUEST)	3 MONTHS
Parkinson's Disease Questionnaire	Parkinson's Disease Questionnaire (PDQ39)	3 MONTHS
iSeismometer application	For all patients: iSeismometer application for mobile phone for Assessment of tremor amplitude and frequency before and after the procedure.	3 MONTHS

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse events of the MRgFUS	Assessment of adverse events of the MRgFUS	3 MONTHS
assessment of the location of lesion on MRI	assessment of the location of the lesion in post procedure MRI	3 MONTHS
Size of the lesion on MRI	volume in mm3 of lesion in post procedure MRI	3 MONTHS
Surrounding edema on MRI	volume in mm3 of edema in post procedure MRI	3 MONTHS

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus
• Investigators: Principal Investigator: Menashe Zaaroor, MD, DSc, Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): May 31, 2017
• Study Completion (Actual): May 31, 2017

Study Registration Dates

• First Submitted: May 29, 2016
• First Submitted That Met QC Criteria: September 27, 2017
• First Posted (Actual): October 3, 2017

Study Record Updates

• Last Update Posted (Actual): October 3, 2017
• Last Update Submitted That Met QC Criteria: September 27, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Parkinson's Disease; Essential Tremor; Tremor; Magnetic Resonance guided Focused Ultrasound
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Parkinson Disease; Tremor; Essential Tremor
• Other Study ID Numbers: 0162-15-RMB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: IPD