Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
InSightec
The objective of this study is to evaluate the incidence and severity of adverse events (AE/AEs) associated with ExAblate Transcranial Magnetic Resonance Guided Focused Ultrasound (MRgFUS) bilateral staged subthalamotomy for the treatment of PD motor features. To determine the effectiveness of the ExAblate Transcranial staged bilateral subthalamotomy to treat cardinal motor features of subjects with PD.
Age
30–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Male or Female age 30 years or older
2. Able and willing to give consent and able to attend all study visits
3. A confirmed diagnosis of Parkinsons Disease
4. Subjects that have received unilateral subthalamotomy at least 6 month before the inclusion in bilateral subthalamotomy and present parkinsonian symptoms
5. Able to localize subthalamic nucleus on MRI for treatment
6. Able to communicate sensations during the ExAblate MRgFUS procedure
You may not be if
1. Hoehn and Yahr stage in the ON medication state of 2.5 or greater
2. Presence of severe dyskinesia as noted by MDS-UPDRS scores
3. Presence of other central neurodegenerative disease
4. Parkinsonian symptoms are a side effect from neuroleptic medications
5. Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse
6. History of a bleeding disorder or receiving anticoagulant
7. Subjects with advanced kidney disease or on dialysis
8. Subjects with known intolerance or allergies to the MRI contrast agents.
9. Presence of unknown or MRI unsafe devices anywhere in the body.
10. History of multiple strokes, or a stroke within past 6 months
11. Subjects with a history of seizures within the past year
