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出境医 / 临床实验 / A Feasibility Study on the Safety and Preliminary Efficacy of Bilateral Subthalamotomy Using MRgFUS for Treatment of PD

A Feasibility Study on the Safety and Preliminary Efficacy of Bilateral Subthalamotomy Using MRgFUS for Treatment of PD

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

Condition or disease Intervention/treatment Phase
Parkinson Disease Neurologic Manifestations Device: Exablate Bilateral Subthalamotomy Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
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
Actual Study Start Date : June 18, 2019
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : June 30, 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: ExAblate 4000 System
Exablate bilateral treatment for Parkinson's Disease Motor Features
 Device: Exablate Bilateral Subthalamotomy
Exablate bilateral treatment for Parkinson's Disease Motor Features
Other Names:
  • MRgFUS
  • Subthalamotomy
Outcome Measures
Primary Outcome Measures :
  1. Safety: Adverse Events [ Time Frame: 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.

  2. Primary Efficacy: Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Off Medication Status [ Time Frame: 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 :
  1. Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) On Medication Status [ Time Frame: Treatment through 6 month ]
    - Mean change (reduction) in the motor MDS-UPDRS score in the on-medication condition (when applicable)

  2. MDS-UPDRS [ Time Frame: Treatment through 12 month ]
    - Mean change (reduction) in specific PD motor features (i.e., tremor, rigidity and akinesia according to MDS-UPDRS III subscores)

  3. MDS-UPDRS (Part I, II and IV) [ Time Frame: Treatment through 6 month ]
    MDS UPDRS I, II and IV

  4. Quality of life assessment [ Time Frame: Treatment through 6 month ]
    Improved Quality of life assessment with the PDQ39


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Contacts
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Contact: KHAJA REHMAN +1 469-607-0497 khajar@insightec.com

Locations
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Spain
Hospital Universitario HM Puerta Del Sur. CINAC Recruiting
Móstoles, Madrid, Spain, 28938
Contact: Raul Martinez, MD    912673201    consulta.hmcinac@hmhospitales.com   
Principal Investigator: Raul Martinez, MD         
Sponsors and Collaborators
InSightec
Investigators
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Principal Investigator: Raul Martinez, MD CINAC-Hospital HM Puerta del Sur
Tracking Information
First Submitted Date  ICMJE May 23, 2019
First Posted Date  ICMJE May 28, 2019
Last Update Posted Date July 28, 2020
Actual Study Start Date  ICMJE June 18, 2019
Estimated Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2019)
  • Safety: Adverse Events [ Time Frame: 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 [ Time Frame: 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
Original Primary Outcome Measures  ICMJE
 (submitted: May 23, 2019)
  • Safety: Adverse Events [ Time Frame: 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: MDS-UPDRS [ Time Frame: Treatment through 6 month ]
    Effectiveness of the ExAblate Transcranial staged bilateral subthalamotomy by analyzing mean change (from baseline to 6 months) in the motor MDS-UPDRS score in the treated group as compared with baseline in the off-medication condition
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2019)
  • Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) On Medication Status [ Time Frame: Treatment through 6 month ]
    - Mean change (reduction) in the motor MDS-UPDRS score in the on-medication condition (when applicable)
  • MDS-UPDRS [ Time Frame: 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) [ Time Frame: Treatment through 6 month ]
    MDS UPDRS I, II and IV
  • Quality of life assessment [ Time Frame: Treatment through 6 month ]
    Improved Quality of life assessment with the PDQ39
Original Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2019)
  • MDS-UPDRS [ Time Frame: Treatment through 6 month ]
    - Mean change in the motor MDS-UPDRS score in the on-medication condition (when applicable)
  • MDS-UPDRS [ Time Frame: Treatment through 12 month ]
    - Mean change in specific PD motor features (i.e., tremor, rigidity and akinesia according to MDS-UPDRS III subscores)
  • MDS-UPDRS [ Time Frame: Treatment through 6 month ]
    MDS UPDRS I, II and IV
  • Quality of life assessment [ Time Frame: Treatment through 6 month ]
    Quality of life assessment with the PDQ39
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Feasibility Study on the Safety and Preliminary Efficacy of Bilateral Subthalamotomy Using MRgFUS for Treatment of PD
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Condition  ICMJE
  • Parkinson Disease
  • Neurologic Manifestations
Intervention  ICMJE Device: Exablate Bilateral Subthalamotomy
Exablate bilateral treatment for Parkinson's Disease Motor Features
Other Names:
  • MRgFUS
  • Subthalamotomy
Study Arms  ICMJE Experimental: ExAblate 4000 System
Exablate bilateral treatment for Parkinson's Disease Motor Features
Intervention: Device: Exablate Bilateral Subthalamotomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 23, 2019) 		10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2022
Estimated Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: KHAJA REHMAN +1 469-607-0497 khajar@insightec.com
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03964272
Other Study ID Numbers  ICMJE PD010B
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party InSightec
Study Sponsor  ICMJE InSightec
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Raul Martinez, MD CINAC-Hospital HM Puerta del Sur
PRS Account InSightec
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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