Neurologic Manifestations, Parkinson Disease
Conditions
Keywords
MRgFUS, ExAblate, Parkinsons Disease, Sub-Thalamotomy
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.
Interventions
DEVICEExablate Bilateral Subthalamotomy
Exablate bilateral treatment for Parkinson's Disease Motor Features
Sponsors
InSightec
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
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 12. Subjects with malignant brain tumors 13. Women who are pregnant or nursing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| MDS-UPDRS (Part I, II and IV) | Treatment through 6 month | MDS UPDRS I, II and IV |
| Quality of life assessment | Treatment through 6 month | Improved Quality of life assessment with the PDQ39 |
Countries
Spain
Contacts
PRINCIPAL_INVESTIGATORRaul Martinez, MD
CINAC-Hospital HM Puerta del Sur
Outcome results
None listed