The Effect of Lesion Characteristics in MRgFUS on Tremor in Essential Tremor and Parkinson's Disease
NCT ID: NCT03300193
Last Updated: 2017-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
23 participants
OBSERVATIONAL
2016-05-31
2017-05-31
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Tremor patients
Essential Tremor and Parkinson's Disease patients with Tremor refractory to pharmacological therapy who underwent Magnetic Resonance guided Focused Ultrasound Surgery (MRgFUS)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 were diagnosed during the trial with additional diagnoses that can affect motor function, quality of life and symptoms of tremor.
18 Years
80 Years
ALL
Yes
Sponsors
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Rambam Health Care Campus
OTHER
Responsible Party
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Menashe Zaaroor, MD PhD
Head of Neurosurgical Department
Principal Investigators
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Menashe Zaaroor, MD, DSc
Role: PRINCIPAL_INVESTIGATOR
Rambam Health Care Campus
Other Identifiers
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0162-15-RMB
Identifier Type: -
Identifier Source: org_study_id