NCT03100474

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.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
1mo left

Started Dec 2016

Longer than P75 for all trials

Geographic Reach
4 countries

9 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Dec 2016Jun 2026

Study Start

First participant enrolled

December 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 4, 2017

Completed
9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

May 2, 2025

Status Verified

April 1, 2025

Enrollment Period

9.5 years

First QC Date

March 29, 2017

Last Update Submit

April 30, 2025

Conditions

Essential TremorParkinson's DiseaseMovement DisordersNeuropathic Pain

Keywords

tremorParkinson'smovementneuropathicpain

Outcome Measures

Primary Outcomes (1)

  • Clinical Rating Scale for Tremor

    CRST

    5 year

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any patients suffering from clinically diagnosed neurologic disorders that can be

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Stanford University

Stanford, California, 94305, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19106, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Swedish Neuroscience Institute

Seattle, Washington, 98122, United States

Location

Sunnybrook

Toronto, Ontario, M4N 3M5, Canada

Location

Rambam Healthcare Campus

Haifa, Israel

Location

Sheba Medical Center

Ramat Gan, Israel

Location

Chang Bing Show Chwan Memorial Hospital

Chang-hua, 505, Taiwan

Location

MeSH Terms

Conditions

Essential TremorParkinson DiseaseMovement DisordersNeuralgiaTremorPain

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System DiseasesParkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesSynucleinopathiesNeurodegenerative DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDyskinesias

Study Officials

  • Howard Eisenberg, MD

    University of Maryland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2017

First Posted

April 4, 2017

Study Start

December 1, 2016

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

May 2, 2025

Record last verified: 2025-04

Locations

US(5)IL(2)CA(1)TW(1)