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

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ClinicalTrials.gov Identifier: NCT03253991
Recruitment Status : Recruiting
First Posted : August 18, 2017
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
InSightec

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.


Condition or disease Intervention/treatment Phase
Essential Tremor Device: MRgFUS treatment Not Applicable

Detailed Description:

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

Safety: To evaluate the incidence and severity of adverse events (AE/AEs) associated with ExAblate Transcranial MRgFUS treatment of medication-refractory ET Effectiveness: To determine the effectiveness of the ExAblate Transcranial MRgFUS treatment of medication-refractory tremor (i.e. ET). Efficacy will be determined utilizing the Clinical Rating Scale for Tremor (CRST) in ET from examinations at baseline and 3-Months post-ExAblate treatment.

• This study is designed as a prospective, multi-site, single-arm study. Assessments of primary efficacy endpoints will compare the three months after ExAblate treatment to Baseline measurements for clinical symptom relief. Safety of ExAblate in the treatment of ET will be collected for one year after ExAblate treatment. Relative Safety will be evaluated using a common description of Significant Clinical Complications for patients treated in this study. This study will be performed on the 3T MR scanners.

The secondary endpoints of the study are as follows:

  1. Quality life claims: Questionnaire for Essential Tremor (QUEST) outcome (upper extremity questions) at Months 3 change from Baseline
  2. Durability (as measured by QUEST upper arm extremity questions) of the procedure as reflected by the efficacy data through change from baseline measures through Month 12 follow up
  3. Subject daily functionalities: as measured by CRST Part-C (subscales)Month 12 as compared to Baseline.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective multi-site, single-arm study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study to Evaluate the Effectiveness and Safety of ExAblate Transcranial MRgFUS Thalamotomy Treatment of Medication Refractory Essential Tremor Subjects
Actual Study Start Date : November 17, 2014
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : January 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tremor

Arm Intervention/treatment
Experimental: MRgFUS treatment
MRgFUS device treatment, thalamotomy
Device: MRgFUS treatment
ExAblate Transcranial MRgFUS Thalamotomy Treatment of Medication Refractory Essential Tremor Subjects
Other Name: Thalamotomy




Primary Outcome Measures :
  1. 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. [ Time Frame: 1 year ]
    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.

  2. 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. [ Time Frame: 5 Years ]
    Assessments of efficacy endpoints will compare the three months after ExAblate treatment to Baseline measurements for clinical symptom relief.



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • 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

Exclusion criteria:

  • 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
  • Subjects with life-threatening systemic disease
  • Subjects with a history of seizures within the past year
  • Subjects with presence or history of psychosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03253991


Contacts
Contact: Martin Bernstein 972542584126 martinb@Insightec.com
Contact: Masatsugu Okamoto +81-42-649-9761 masatsuguo@Insightec.com

Locations
China, Haidian District Of Beijing
Chinese PLA General Hospital Not yet recruiting
Beijing, Haidian District Of Beijing, China
Contact: Rui Zong, MD    13810094888    zongrui11@126.com   
Principal Investigator: Pan Longsheng, Professor         
Japan
Sadamoto Hospital Active, not recruiting
Ehime, Japan, 790-0052
Shonan Fujisawa Tokushukai Hospital Active, not recruiting
Fujisawa, Japan, 2510041
Hokkaido Ohno Memorial Hospital Recruiting
Hokkaido, Japan, 063-0052
Contact: Yuzo Terakawa    +81-11-665-0020    terakawa@kojinkai.or.jp   
Hokuto Active, not recruiting
Hokkaido, Japan, 080-0833
Ohanishi Noerological Center Active, not recruiting
Hyōgo, Japan, 6740064
Kumagaya General Hospital Active, not recruiting
Kumagaya, Japan, 360-8567
Department of Neurosurgery, Osaka University Hospital Active, not recruiting
Osaka, Japan, 565-0871
Tokyo Women's Medical University Hospital Active, not recruiting
Tokyo, Japan, 62-8666
Taiwan
Chang Bing Show Chwan Memorial Hospital Active, not recruiting
Chang Hua, Taiwan, 505
Sponsors and Collaborators
InSightec

Responsible Party: InSightec
ClinicalTrials.gov Identifier: NCT03253991     History of Changes
Other Study ID Numbers: ET002J
First Posted: August 18, 2017    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Tremor
Essential Tremor
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases