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

Sponsor
InSightec (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03964272
Collaborator
(none)
3
Enrollment
1
Location
1
Arm
48.4
Anticipated Duration (Months)
0.1
Patients Per Site Per Month

Study Details

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
  • Device: Exablate Bilateral Subthalamotomy
 N/A

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

Study Type:
Interventional
Actual Enrollment :
3 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 :
Jun 18, 2019
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Jun 30, 2023

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 [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 [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 [Treatment through 6 month]

      - Mean change (reduction) in the motor MDS-UPDRS score in the on-medication condition (when applicable)

    2. 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)

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

      MDS UPDRS I, II and IV

    4. Quality of life assessment [Treatment through 6 month]

      Improved Quality of life assessment with the PDQ39

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Universitario HM Puerta Del Sur. CINAC Móstoles Madrid Spain 28938

    Sponsors and Collaborators

    • InSightec

    Investigators

    • Principal Investigator: Raul Martinez, MD, CINAC-Hospital HM Puerta del Sur

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    InSightec
    ClinicalTrials.gov Identifier:
    NCT03964272
    Other Study ID Numbers:
    • PD010B
    First Posted:
    May 28, 2019
    Last Update Posted:
    Aug 3, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by InSightec
    MRgFUS
    ExAblate
    Parkinsons Disease
    Sub-Thalamotomy
    Additional relevant MeSH terms:
    Parkinson Disease
    Neurologic Manifestations

    Study Results

    No Results Posted as of Aug 3, 2022