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

NCT03964272 | Completed

• 1 other identifier: PD010B
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

Conditions

Parkinson Disease; Neurologic Manifestations

Keywords

MRgFUS; ExAblate; Parkinsons Disease; Sub-Thalamotomy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) On Medication Status

  Treatment through 6 month

• MDS-UPDRS

  Treatment through 12 month

• MDS-UPDRS (Part I, II and IV)

  Treatment through 6 month

• Quality of life assessment

  Treatment through 6 month

Study Arms (1)

ExAblate 4000 System

EXPERIMENTAL

Exablate bilateral treatment for Parkinson's Disease Motor Features

Device: Exablate Bilateral Subthalamotomy

Interventions

Exablate Bilateral Subthalamotomy DEVICE

Exablate bilateral treatment for Parkinson's Disease Motor Features

Also known as: MRgFUS, Subthalamotomy

ExAblate 4000 System

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Able to localize subthalamic nucleus on MRI for treatment
• Able to communicate sensations during the ExAblate MRgFUS procedure

You may not qualify if:

• 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

Sponsors & Collaborators

• InSightec: lead

Study Sites (1)

Hospital Universitario HM Puerta Del Sur. CINAC

Móstoles, Madrid, 28938, Spain

Location

MeSH Terms

Conditions

Parkinson Disease; Neurologic Manifestations

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Raul Martinez, MD

  CINAC-Hospital HM Puerta del Sur

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: May 28, 2019
• Study Start: June 18, 2019
• Primary Completion: November 7, 2023
• Study Completion: November 7, 2023
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)