Back to resultsA Feasibility Study on the Safety and Preliminary Efficacy of Bilateral Subthalamotomy Using MRgFUS for Treatment of PD
Primary Purpose
Parkinson Disease, Neurologic Manifestations
Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Exablate Bilateral Subthalamotomy
Sponsored by
About this trial
This is an interventional device feasibility trial for Parkinson Disease focused on measuring MRgFUS, ExAblate, Parkinsons Disease, Sub-Thalamotomy
Eligibility Criteria
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
- 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
Sites / Locations
- Hospital Universitario HM Puerta Del Sur. CINAC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ExAblate 4000 System
Arm Description
Exablate bilateral treatment for Parkinson's Disease Motor Features
Outcomes
Primary Outcome Measures
Safety: Adverse Events
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
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
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) On Medication Status
- Mean change (reduction) in the motor MDS-UPDRS score in the on-medication condition (when applicable)
MDS-UPDRS
- 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)
MDS UPDRS I, II and IV
Quality of life assessment
Improved Quality of life assessment with the PDQ39
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03964272
Brief Title
A Feasibility Study on the Safety and Preliminary Efficacy of Bilateral Subthalamotomy Using MRgFUS for Treatment of PD
Official Title
A Feasibility Study on the Safety and Preliminary Efficacy of Bilateral Subthalamotomy Using the ExAblate Transcranial System to Treat the Cardinal Motor Features of Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 18, 2019 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
InSightec
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Neurologic Manifestations
Keywords
MRgFUS, ExAblate, Parkinsons Disease, Sub-Thalamotomy
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ExAblate 4000 System
Arm Type
Experimental
Arm Description
Exablate bilateral treatment for Parkinson's Disease Motor Features
Intervention Type
Device
Intervention Name(s)
Exablate Bilateral Subthalamotomy
Other Intervention Name(s)
MRgFUS, Subthalamotomy
Intervention Description
Exablate bilateral treatment for Parkinson's Disease Motor Features
Primary Outcome Measure Information:
Title
Safety: Adverse Events
Description
To evaluate the incidence and severity of adverse events (AE/AEs) associated with ExAblate subthalamotomy for the treatment of PD motor features.
Time Frame
Treatment through 6 month
Title
Primary Efficacy: Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Off Medication Status
Description
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
Time Frame
Treatment through 6 month
Secondary Outcome Measure Information:
Title
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) On Medication Status
Description
- Mean change (reduction) in the motor MDS-UPDRS score in the on-medication condition (when applicable)
Time Frame
Treatment through 6 month
Title
MDS-UPDRS
Description
- Mean change (reduction) in specific PD motor features (i.e., tremor, rigidity and akinesia according to MDS-UPDRS III subscores)
Time Frame
Treatment through 12 month
Title
MDS-UPDRS (Part I, II and IV)
Description
MDS UPDRS I, II and IV
Time Frame
Treatment through 6 month
Title
Quality of life assessment
Description
Improved Quality of life assessment with the PDQ39
Time Frame
Treatment through 6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raul Martinez, MD
Organizational Affiliation
CINAC-Hospital HM Puerta del Sur
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario HM Puerta Del Sur. CINAC
City
Móstoles
State/Province
Madrid
ZIP/Postal Code
28938
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Feasibility Study on the Safety and Preliminary Efficacy of Bilateral Subthalamotomy Using MRgFUS for Treatment of PD
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