Status:
COMPLETED
The Effect of Lesion Characteristics in MRgFUS on Tremor in Essential Tremor and Parkinson's Disease
Lead Sponsor:
Rambam Health Care Campus
Conditions:
Tremor
Eligibility:
All Genders
18-80 years
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 characte...
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. Clin...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 31 2017
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT03300193
Start Date
May 1 2016
End Date
May 31 2017
Last Update
October 3 2017
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.