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

Tremor Clinical Trial

— MRgFUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03300193
• Other study ID #: 0162-15-RMB
• Status: Completed
• Phase: N/A
• First received: May 29, 2016
• Last updated: September 27, 2017
• Start date: May 2016
• Est. completion date: May 31, 2017

Study information

• Verified date: September 2017
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: May 31, 2017
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Essential Tremor
• Parkinson Disease
• Tremor

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	adverse events of the MRgFUS	Assessment of adverse events of the MRgFUS	3 MONTHS
Other	assessment of the location of lesion on MRI	assessment of the location of the lesion in post procedure MRI	3 MONTHS
Other	Size of the lesion on MRI	volume in mm3 of lesion in post procedure MRI	3 MONTHS
Other	Surrounding edema on MRI	volume in mm3 of edema in post procedure MRI	3 MONTHS
Primary	Clinical Rating Scale for Tremor	Tremor score: In ET patients - Clinical Rating Scale for Tremor (CRST)	3 MONTHS
Primary	Motor part of Unified PD Rating Scale	In PD patients - Motor part of Unified PD Rating Scale (UPDRS)	3 MONTHS
Secondary	Quality of Life Essential Tremor Questionnaire	Quality of life: Quality of Life Essential Tremor Questionnaire (QUEST)	3 MONTHS
Secondary	Parkinson's Disease Questionnaire	Parkinson's Disease Questionnaire (PDQ39)	3 MONTHS
Secondary	iSeismometer application	For all patients: iSeismometer application for mobile phone for Assessment of tremor amplitude and frequency before and after the procedure.	3 MONTHS