Continued Access Protocol: ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Essential Tremors

NCT02289560 | Completed Results DMC

• 1 other identifier: ET002CA
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 7

Brief Summary

The objective of this prospective, multi site, single-arm study is to capture the efficacy of treatment using the ExAblate Transcranial System and to further demonstrate safety in medication-refractory tremor in patients with essential tremor (ET).

Conditions

Essential Tremor

Outcome Measures

Primary Outcomes (1)

• Number of Device and Procedure Related Adverse Events.

  The cumulative sum of adverse events was followed through Year 5 of the study.

  5 Years post treatment

Secondary Outcomes (4)

• Tremor Motor Score - Clinical Rating Scale for Tremor (CRST) Part A (Upper Extremity) + Part B Scores Summed

  Baseline, 3 Months, 6 Months, 12 Months, 2, 3, 4, 5 Years post treatment

• Clinical Rating Scale for Tremor (CRST Part A) Posture Score Change From Baseline

  Baseline, 3 Months, 6 Months, 12 Months, 2, 3, 4, 5 Years post treatment

• Clinical Rating Scale for Tremor Part C - Activities of Daily Living.

  Baseline, 3 Months, 6 Months, 12 Months, 2, 3, 4, 5 Years post treatment

• Quality of Life in Essential Tremor Total (QUEST)

  Baseline, 3 Months, 6 Months, 12 Months, 2, 3, 4, 5 Years post treatment

Study Arms (1)

Transcranial ExAblate

EXPERIMENTAL

Transcranial ExAblate

Device: Transcranial ExAblate

Interventions

Transcranial ExAblate DEVICE

Transcranial ExAblate

Also known as: ExAblate, TcMRgFUS, Thalamotomy

Transcranial ExAblate

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women, age 22 years and older
• Subjects who are able and willing to give informed consent and able to attend all study visits
• Subjects with a diagnosis of Essential Tremor as confirmed from clinical history and examination by a neurologist or neurosurgeon specialized in movement disorder
• Subject exhibits a significant disability from their ET despite medical treatment
• Subjects should be on a stable dose of all ET medications for 30 days prior to study entry
• Subject is able to communicate sensations during the ExAblate Transcranial procedure

You may not qualify if:

• Subjects with unstable cardiac status
• Severe hypertension
• Subjects with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
• Known intolerance or allergies to the MRI contrast agent including advanced kidney disease or severely impaired renal function
• Significant claustrophobia that cannot be managed with mild medication
• Current medical condition resulting in abnormal bleeding and/or coagulopathy
• Receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within one week of focused ultrasound procedure or drugs known to increase risk or hemorrhage
• History of intracranial hemorrhage
• History of multiple strokes, or a stroke within past 6 months
• Subjects who are not able or willing to tolerate the required prolonged stationary supine position during treatment
• Are participating or have participated in another clinical trial in the last 30 days
• Subjects unable to communicate with the investigator and staff
• Subjects with a history of seizures within the past year
• Subjects with brain tumors

Sponsors & Collaborators

• InSightec: lead

Study Sites (7)

Stanford University Medical Center

Stanford, California, 94305, United States

Location

University of Maryland Medical System

Baltimore, Maryland, 21201, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

The Ohio State Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19106, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

MeSH Terms

Conditions

Essential Tremor

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Nadir Alikacem, SVP Global Regulated Clinical Affairs
• Organization: Insightec

nadira@insightec.com

214-630-9900

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: November 10, 2014
• First Posted: November 13, 2014
• Study Start: April 1, 2015
• Primary Completion: February 18, 2022
• Study Completion: March 10, 2023
• Last Updated: July 3, 2024
• Results First Posted: July 3, 2024

Record last verified: 2024-06

Locations

US (7)