A Study to Evaluate the Effectiveness and Safety of ExAblate MRgFUS on Essential Tremor

NCT03253991 | Terminated DMC

• 1 other identifier: ET002J
• Study Type: interventional
• Target: 154
• Locations: 3 countries
• Sites: 11

Brief Summary

A Study to Evaluate the Effectiveness and Safety of ExAblate Transcranial MRgFUS Thalamotomy Treatment of Medication Refractory Essential Tremor Subjects The objective of this prospective, single-arm study is to test the efficacy of treatment using the ExAblate Transcranial System and to further demonstrate safety in medication-refractory tremor inpatients with essential tremor (ET). The Indications for Use claim for this system is as follows: Treatment of medication-refractory tremor in patients with essential tremor.

Conditions

Essential Tremor

Outcome Measures

Primary Outcomes (2)

• Safety - Will be determined evaluating incidence and severity of device related complications from first treatment day visit through all follow ups. Relative Safety will be evaluated describing Significant Clinical Complications for patients treated.

  All AEs will be reported and categorized by investigators as definitely, probably, possibly, or unrelated to the device or procedure and categorized by treatment group / treatment arm. Relative Safety will be evaluated using a common description of Significant Clinical Complications for patients treated in this study.

  1 year

• Effectiveness - Will be evaluated using the Clinical Rating Scale for Tremors (CRST) for ET subjects. Comparison will be performed from examinations at baseline and 3-Months post-ExAblate treatment.

  Assessments of efficacy endpoints will compare the three months after ExAblate treatment to Baseline measurements for clinical symptom relief.

  5 Years

Study Arms (1)

MRgFUS treatment

EXPERIMENTAL

MRgFUS device treatment, thalamotomy

Device: MRgFUS treatment

Interventions

MRgFUS treatment DEVICE

ExAblate Transcranial MRgFUS Thalamotomy Treatment of Medication Refractory Essential Tremor Subjects

Also known as: Thalamotomy

MRgFUS treatment

Eligibility Criteria

• Age: 22 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women age 22 years or older
• A diagnosis of ET as confirmed from clinical history and examination by a neurologist or neurosurgeon specialized in movement disorder
• Have had an inadequate response to one or two oral doses of medication, per local standards. An inadequate medication trial is defined as a therapeutic dose of each medication and poor response to drug, or the development of side effects as the medication dose is titrated.
• Able to communicate sensations during the ExAblate TcMRgFUS treatment

You may not qualify if:

• Subjects with unstable cardiac status
• Severe hypertension (diastolic BP \> 100 on medication)
• 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 (e.g. Gadolinium or Magnevist) including advanced kidney disease
• Patient with severely impaired renal function
• History of abnormal bleeding and/or coagulopathy
• History of immunocompromise including those who are HIV positive.
• History of intracranial hemorrhage
• Cerebrovascular disease (multiple CVA or CVA within 6 months)
• Subjects with uncontrolled symptoms and signs of increased intracranial pressure (e.g., headache, nausea, vomiting, lethargy, papilledema).
• Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment (can be up to 4 hrs of total table time.)
• Are participating or have participated in another clinical trial in the last 30 days
• Significant claustrophobia that cannot be managed with mild medication.
• Presence of any other neurodegenerative disease such as Parkinson-plus syndromes suspected on neurological examination.
• Presence of significant cognitive impairment

Sponsors & Collaborators

• InSightec: lead

Study Sites (11)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

Henan Provincial People's Hospital

Zhengzhou, Henan, 450003, China

Location

Sadamoto Hospital

Ehime, 790-0052, Japan

Location

Shonan Fujisawa Tokushukai Hospital

Fujisawa, 2510041, Japan

Location

Hokkaido Ohno Memorial Hospital

Hokkaido, 063-0052, Japan

Location

Hokuto

Hokkaido, 080-0833, Japan

Location

Ohanishi Noerological Center

Hyōgo, 6740064, Japan

Location

Kumagaya General Hospital

Kumagaya, 360-8567, Japan

Location

Department of Neurosurgery, Osaka University Hospital

Osaka, 565-0871, Japan

Location

Tokyo Women's Medical University Hospital

Tokyo, 62-8666, Japan

Location

Chang Bing Show Chwan Memorial Hospital

Chang-hua, 505, Taiwan

Location

Related Publications (1)

• Zong R, Li X, Yin C, He J, Zhang D, Bian X, Huang L, Zhou J, Ling Z, Ma L, Lou X, Pan L, Yu X. Magnetic resonance-guided focused ultrasound for essential tremor: a prospective, single center, single-arm study. Neural Regen Res. 2024 Sep 1;19(9):2075-2080. doi: 10.4103/1673-5374.391192. Epub 2024 Jan 12.

  PMID: 38227538 DERIVED

MeSH Terms

Conditions

Essential Tremor

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Study Design

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

Model Details: Prospective multi-site, single-arm study

Study Record Dates

• First Submitted: July 24, 2017
• First Posted: August 18, 2017
• Study Start: November 17, 2014
• Primary Completion: February 2, 2023
• Study Completion: February 2, 2023
• Last Updated: April 20, 2023

Record last verified: 2023-04

Locations

TW (1); CN (2); JP (8)