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

NCT ID: NCT03964272

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-18

Study Completion Date

2023-11-07

Brief Summary

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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

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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.

Conditions

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Parkinson Disease Neurologic Manifestations

Keywords

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MRgFUS ExAblate Parkinsons Disease Sub-Thalamotomy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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ExAblate 4000 System

Exablate bilateral treatment for Parkinson's Disease Motor Features

Group Type EXPERIMENTAL

Exablate Bilateral Subthalamotomy

Intervention Type DEVICE

Exablate bilateral treatment for Parkinson's Disease Motor Features

Interventions

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Exablate Bilateral Subthalamotomy

Exablate bilateral treatment for Parkinson's Disease Motor Features

Intervention Type DEVICE

Other Intervention Names

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MRgFUS Subthalamotomy

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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InSightec

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raul Martinez, MD

Role: PRINCIPAL_INVESTIGATOR

CINAC-Hospital HM Puerta del Sur

Locations

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Hospital Universitario HM Puerta Del Sur. CINAC

Móstoles, Madrid, Spain

Site Status

Countries

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Spain

Other Identifiers

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PD010B

Identifier Type: -

Identifier Source: org_study_id