A Feasibility Study on the Safety and Preliminary Efficacy of Bilateral Subthalamotomy Using MRgF… (NCT03964272) | Clinical Trial Compass
CompletedNot Applicable
A Feasibility Study on the Safety and Preliminary Efficacy of Bilateral Subthalamotomy Using MRgFUS for Treatment of PD
Spain6 participantsStarted 2019-06-18
Plain-language summary
The objective of this study is to test the safety and preliminary efficacy of staged bilateral subthalamotomy performed using the ExAblate Transcranial System for the treatment of Parkinson's disease (PD) motor features
Who can participate
Age range30 Years – 75 Years
SexALL
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Inclusion criteria
✓. Male or Female age 30 years or older
✓. Able and willing to give consent and able to attend all study visits
✓. A confirmed diagnosis of Parkinsons Disease
✓. Subjects that have received unilateral subthalamotomy at least 6 month before the inclusion in bilateral subthalamotomy and present parkinsonian symptoms
✓. Able to localize subthalamic nucleus on MRI for treatment
✓. Able to communicate sensations during the ExAblate MRgFUS procedure
Exclusion criteria
✕. Hoehn and Yahr stage in the ON medication state of 2.5 or greater
✕. Presence of severe dyskinesia as noted by MDS-UPDRS scores
✕. Presence of other central neurodegenerative disease
✕. Parkinsonian symptoms are a side effect from neuroleptic medications
✕. Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse
✕. History of a bleeding disorder or receiving anticoagulant
✕. Subjects with advanced kidney disease or on dialysis
✕
What they're measuring
1
Safety: Adverse Events
Timeframe: Treatment through 6 month
2
Primary Efficacy: Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Off Medication Status