Skip to main content
OpenTrials
Completed

NCT Number: NCT03964272

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Synucleinopathies

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario HM Puerta Del Sur. CINAC

Móstoles, Madrid, 28938, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Subjects that have received unilateral subthalamotomy at least 6 month before the inclusion in bilateral subthalamotomy and present parkinsonian symptoms
  • Able to localize subthalamic nucleus on MRI for treatment
  • Able to communicate sensations during the ExAblate MRgFUS procedure

Exclusion criteria

  • 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

Treatment and study plan

Exablate Bilateral Subthalamotomy

Device

Exablate bilateral treatment for Parkinson's Disease Motor Features

Other names: MRgFUS, Subthalamotomy

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

InSightec

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
May 28, 2019
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.