NCT03935581

Brief Summary

The objective of this study is to evaluate the safety and feasibility of Auto Focusing (AF) echo imaging using the ExAblate Neuro system

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

Geographic Reach
2 countries

2 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

April 18, 2019

Completed
7 days until next milestone

Study Start

First participant enrolled

April 25, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 2, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

September 17, 2021

Status Verified

September 1, 2021

Enrollment Period

1.7 years

First QC Date

April 18, 2019

Last Update Submit

September 15, 2021

Conditions

Tremor, EssentialNeurologic ManifestationsTremor

Keywords

MRgFUSExAblateEssential TremorAuto-Focusing Echo Imaging

Outcome Measures

Primary Outcomes (1)

  • Incidence of Device and Procedure related Adverse Events

    Treatment through 1 month

Study Arms (1)

ExAblate 4000 System

EXPERIMENTAL

ExAblate Neuro system to perform AF echo imaging in treatment of Essential Tremor

Device: ExAblate

Interventions

ExAblateDEVICE

Auto Focusing (AF) echo imaging

ExAblate 4000 System

Eligibility Criteria

Age22 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or Female age 22 years or older
  • Able and willing to give consent and able to attend all study visits
  • A confirmed diagnosis of Essential Tremor resistant to medication therapy
  • Able to fit into MRI unit
  • Able to tolerate the procedure with or without some form of sedation
  • Able to communicate sensations during the ExAblate MRgFUS procedure
  • Able to activate Stop Sonication button during the ExAblate MRgFUS procedure

You may not qualify if:

  • Presence of unknown or MRI unsafe devices anywhere in the body.
  • Patients with known intolerance or allergies to the MRI contrast agents
  • Women who are pregnant
  • Patients with advanced kidney disease or on dialysis
  • Significant cardiac disease or unstable hemodynamic status
  • Patients exhibiting any behavior(s) consistent with ethanol or substance abuse
  • History of a bleeding disorder
  • Patients receiving anticoagulant or drugs known to increase risk of hemorrhage
  • Patients with cerebrovascular disease
  • Patients with brain tumors
  • Individuals who are not able or unwilling to tolerate the required prolonged stationary position during treatment (approximately 2-3 hours)
  • Patients who are currently participating in another clinical investigation
  • Patients unable to communicate with the investigator and staff
  • Patients who have cardiac shunts
  • Patients with relative contraindications to Definity ultrasound contrast agent including subjects with a family or personal history of arrhythmia's
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sunnybrook

Toronto, Ontario, M4N 3M5, Canada

Location

Yonsei University Health System, Severance Hospital

Seoul, Seodaemun-gu, 03722, South Korea

Location

Related Publications (2)

  • Chang KW, Rachmilevitch I, Chang WS, Jung HH, Zadicario E, Prus O, Chang JW. Safety and Efficacy of Magnetic Resonance-Guided Focused Ultrasound Surgery With Autofocusing Echo Imaging. Front Neurosci. 2021 Jan 12;14:592763. doi: 10.3389/fnins.2020.592763. eCollection 2020.

    PMID: 33510610DERIVED

  • Jones RM, Huang Y, Meng Y, Scantlebury N, Schwartz ML, Lipsman N, Hynynen K. Echo-Focusing in Transcranial Focused Ultrasound Thalamotomy for Essential Tremor: A Feasibility Study. Mov Disord. 2020 Dec;35(12):2327-2333. doi: 10.1002/mds.28226. Epub 2020 Aug 20.

    PMID: 32815611DERIVED

MeSH Terms

Conditions

Essential TremorNeurologic ManifestationsTremor

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsDyskinesias

Study Officials

  • Nir Lipsman

    Sunnybrook Health Science Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2019

First Posted

May 2, 2019

Study Start

April 25, 2019

Primary Completion

December 31, 2020

Study Completion

December 30, 2021

Last Updated

September 17, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)CA(1)