Magnetic Resonance (MR) Guided Functional Ultrasound-Neurosurgery for Movement Disorders
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|ClinicalTrials.gov Identifier: NCT01698450|
Recruitment Status : Completed
First Posted : October 3, 2012
Last Update Posted : October 9, 2014
|Condition or disease||Intervention/treatment||Phase|
|Essential Tremor Dystonia Parkinson's Disease||Device: Non-invasive intervention with focused ultrasound (ExAblate 4000)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||MR-Guided Functional Ultrasound-Neurosurgery for Movement Disorders|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
|Focused Ultrasound for Movement Disorders||
Device: Non-invasive intervention with focused ultrasound (ExAblate 4000)
Non-invasive brain intervention using MR-guided focused ultrasound
Other Name: ExAblate 4000
- Lesion Size [ Time Frame: 3 months ]Size of lesion in the target area for each sonication as a function of applied energy/temperature.
- Patient Safety [ Time Frame: 3 months ]Number of Patients with Adverse Events as a Measure of Safety and Tolerability.
- Clinical efficacy and QOL [ Time Frame: 3 months ]Efficacy and QOL will be quantified on respective rating scales (specified in protocol).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01698450
|MR-Center, University Children's Hospital|
|Principal Investigator:||Ernst - Martin, MD||University Children's Hospital, Zurich|
|Principal Investigator:||Ronald - Bauer, MD||Neurosurgey, Kantonsspital St. Gallen, Switzerland|