Global Registry: ExAblate Neuro MR Guided Focused Ultrasound (MRgFUS) of Neurological Disorders:

A global post approval study to collect safety and effectiveness data related to ExAblate Neuro for the treatment of certain disorders such as Essential Tremor, Parkinson's Movement Disorders, or Neuropathic Pain within the thalamus and/or pallidum.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Essential Tremor Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Dyskinesias Movement Disorders Nervous System Diseases Neuralgia Neurodegenerative Diseases Neurologic Manifestations Neuromuscular Diseases Neuropathic Pain Pain Parkinson Disease Parkinson's Disease Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms Synucleinopathies Tremor

Sex eligibility

All sexes

Study type

Observational

Primary location

Sunnybrook, Toronto, Ontario, Canada

About this study

A global, multi-center, open-label, observational registry to capture safety and effectiveness data related to ExAblate Neuro, an MRI guided focused ultrasound device designed to lesion tissue deep within the brain using sound waves without the need for craniotomy. This registry includes certain regional and country specific approved thalamotomy and pallidotomy procedures using ExAblate Neuro for the treatment of various neurologic disorders such as essential tremor, Parkinson's movement disorders, and neuropathic pain. Treatment targets/indications are country/region dependent based on approved labeling within that region.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Meets labeling indication for use per information for prescribers
Target is accessible by Focused Ultrasound per treatment planning parameters

Exclusion criteria

Do not agree to participate or who are unlikely to participate over an extended period of time

Treatment and study plan

Primary outcomes

Clinical Rating Scale for Tremor

Time frame: 5 year

CRST

Sponsors and collaborators

Lead sponsor

InSightec

Industry

Registry information

Official study title

Global Registry: ExAblate 4000 Transcranial MR Guided Focused Ultrasound (TcMRgFUS) of Neurological Disorders:

Important dates

Study start: 2016
Primary completion: 2026
Study completion: 2026
First posted: Apr 4, 2017
Registry last updated: May 2, 2025

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.

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

Active, Not Recruiting