A Feasibility Study on the Safety and Preliminary Efficacy of Bilateral Subthalamotomy Using MRgFUS for Treatment of PD
- Conditions
- Parkinson DiseaseNeurologic Manifestations
- Interventions
- Device: Exablate Bilateral Subthalamotomy
- Registration Number
- NCT03964272
- Lead Sponsor
- InSightec
- Brief 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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 3
- 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
- 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
- Subjects with known intolerance or allergies to the MRI contrast agents.
- Presence of unknown or MRI unsafe devices anywhere in the body.
- History of multiple strokes, or a stroke within past 6 months
- Subjects with a history of seizures within the past year
- Subjects with malignant brain tumors
- Women who are pregnant or nursing
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ExAblate 4000 System Exablate Bilateral Subthalamotomy Exablate bilateral treatment for Parkinson's Disease Motor Features
- Primary Outcome Measures
Name Time Method Safety: Adverse Events Treatment through 6 month To evaluate the incidence and severity of adverse events (AE/AEs) associated with ExAblate subthalamotomy for the treatment of PD motor features.
Primary Efficacy: Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Off Medication Status Treatment through 6 month Effectiveness of the ExAblate Transcranial staged bilateral subthalamotomy by analyzing mean change (reduction from baseline to 6 months) in the motor MDS-UPDRS score in the treated group as compared with baseline in the off-medication condition
- Secondary Outcome Measures
Name Time Method Quality of life assessment Treatment through 6 month Improved Quality of life assessment with the PDQ39
MDS-UPDRS (Part I, II and IV) Treatment through 6 month MDS UPDRS I, II and IV
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) On Medication Status Treatment through 6 month - Mean change (reduction) in the motor MDS-UPDRS score in the on-medication condition (when applicable)
MDS-UPDRS Treatment through 12 month - Mean change (reduction) in specific PD motor features (i.e., tremor, rigidity and akinesia according to MDS-UPDRS III subscores)
Trial Locations
- Locations (1)
Hospital Universitario HM Puerta Del Sur. CINAC
🇪🇸Móstoles, Madrid, Spain