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

Active, not recruiting

• Conditions: Essential Tremor; Parkinson's Disease; Movement Disorders; Neuropathic Pain

• Registration Number: NCT03100474
• Lead Sponsor: InSightec

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2017-03-29
• Study First Submitted QC: 2017-04-03
• Study First Posted: 2017-04-04
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-02
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical Rating Scale for Tremor	5 year	CRST

Trial Locations

Locations (9)

Chang Bing Show Chwan Memorial Hospital; 🇨🇳 Chang Hua, Taiwan

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States

Stanford University; 🇺🇸 Stanford, California, United States

University of Maryland; 🇺🇸 Baltimore, Maryland, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Swedish Neuroscience Institute; 🇺🇸 Seattle, Washington, United States

Sunnybrook; 🇨🇦 Toronto, Ontario, Canada

Rambam Healthcare Campus; 🇮🇱 Haifa, Israel

Sheba Medical Center; 🇮🇱 Ramat Gan, Israel