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 the ExAblate Transcranial System to Treat the Cardinal Motor Features of Parkinson's Disease

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

Study Overview

• Status: Active, not recruiting
• Conditions: Neurologic Manifestations; Parkinson Disease
• Intervention / Treatment: Device: Exablate Bilateral Subthalamotomy

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: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Móstoles, Madrid, Spain, 28938
      • Hospital Universitario HM Puerta Del Sur. CINAC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DEVICE_FEASIBILITY
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Treatment through 6 month
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	Treatment through 6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Treatment through 6 month
MDS-UPDRS	- Mean change (reduction) in specific PD motor features (i.e., tremor, rigidity and akinesia according to MDS-UPDRS III subscores)	Treatment through 12 month
MDS-UPDRS (Part I, II and IV)	MDS UPDRS I, II and IV	Treatment through 6 month
Quality of life assessment	Improved Quality of life assessment with the PDQ39	Treatment through 6 month

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 18, 2019
• Primary Completion (ANTICIPATED): December 30, 2022
• Study Completion (ANTICIPATED): June 30, 2023

Study Registration Dates

• First Submitted: May 23, 2019
• First Submitted That Met QC Criteria: May 23, 2019
• First Posted (ACTUAL): May 28, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 3, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: MRgFUS; ExAblate; Parkinsons Disease; Sub-Thalamotomy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Neurologic Manifestations
• Other Study ID Numbers: PD010B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No