UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023639
Receipt number R000027204
Scientific Title A Study to Evaluate the Effectiveness and Safety of ExAblate Transcranial MRgFUS Thalamotomy Treatment of Medication Refractory Essential Tremor Subjects
Date of disclosure of the study information 2017/01/01
Last modified on 2016/08/16 09:23:40

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Basic information

Public title

A Study to Evaluate the Effectiveness and Safety of ExAblate Transcranial MRgFUS
Thalamotomy Treatment of Medication
Refractory Essential Tremor Subjects

Acronym

Transcranial MRgFUS Thalamotomy on
Essential Tremor Subjects

Scientific Title

A Study to Evaluate the Effectiveness and Safety of ExAblate Transcranial MRgFUS
Thalamotomy Treatment of Medication
Refractory Essential Tremor Subjects

Scientific Title:Acronym

Transcranial MRgFUS Thalamotomy on
Essential Tremor Subjects

Region

Japan


Condition

Condition

Essential Tremor

Classification by specialty

Neurology Neurosurgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

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).

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1. Safety
Safety of ExAblate will be determined by an evaluation of the incidence and severity of device / treatment related complications from the first treatment day visit through ALL study follow ups. Adverse events (type, frequency, severity) are expected to be similar to those of previous studies using ExAblate TcMRgFUS for Thalamotomy.
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.

2. Effectiveness
Primary effectiveness will be evaluated using a validated, tremor rating scale: the Clinical Rating Scale for Tremors (CRST) for ET subjects, based upon subjects in whom unilateral ExAblate lesioning is attempted (i.e., Intent-to-Treat analysis).
Clinical assessments will be made at the following time points: screening, baseline with subjects on confirmed stable medication (at 1-months post screening), and post-treatment at 1 week, 1 month, 3 months, 6 months, and 12 months.

Key secondary outcomes

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


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment Maneuver

Interventions/Control_1

ExAblate MR Guided Focused Ultrasound is an attractive modality for non-invasive thermal ablation of soft tissue tumors [1-6]. Treatment begins by acquiring a series of MR images of the target tissue. The physician then reviews the images on the ExAblate system workstation, identifies a target volume on the MR images, delineates the treatment contours on the images, and reviews the treatment plan. Therapy planning software calculates the parameters required to effectively treat the defined region. During the treatment, an ultrasound transducer generates a point of focused ultrasound energy, called a sonication. The sonication raises the tissue temperature within a well-defined region, causing a thermal coagulation effect. MR images acquired during sonication provide a quantitative, real-time temperature map of the entire field-of-view around the target area to confirm the location of the sonication and the size of the coagulated region. The sonication process is repeated at multiple adjacent points to cover the entire prescribed treatment volume.

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

22 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Men and women age 22 years or older
2. Subjects who are able and willing to give consent and able to attend all study visits.
3. A diagnosis of ET as confirmed from clinical history and examination by a neurologist or neurosurgeon specialized in movement disorder
4. 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.
5. Following the 1-month medication stability period, subject must be on stable medication for tremor
a. The 1-Month stability period visit will be 1-month post consent date
6. Vim nucleus of thalamus can be target by the ExAblate device. The thalamic region must be apparent on MRI such that targeting can be performed by measurement from a line connecting the anterior and posterior commissures of the brain.
7. Able to communicate sensations during the ExAblate TcMRgFUS treatment
8. Postural or intention tremor severity score of greater than or equal to 2 in the dominant hand/arm as measured by the CRST rating scale while stable on medication.
9. May have bilateral appendicular tremor
10. Significant disability due to essential tremor despite medical treatment (CRST score of 2 or above in any one of the items 16-23 from the Disability subsection of the CRST: [speaking, feeding other than liquids, bringing liquids to mouth, hygiene, dressing, writing, working, and social activities])
11. Inclusion and exclusion criteria have been agreed upon by two members of the medical team.
12. Subjects on stable antidepressant medications for at least 3 months may be enrolled into this study (i.e., no change in medication drug or dosage for 3 months).

Key exclusion criteria

1. Subjects with unstable cardiac status
2. Subjects exhibiting any behaviors consistent with ethanol or substance abuse
3. Severe hypertension
4. Subjects with standard contraindications for MR imaging
5. Known intolerance or allergies to the MRI contrast agent
6. Patient with severely impaired renal function and/or who is on dialysis
7. History of abnormal bleeding and/or coagulopathy
8. Receiving anticoagulant or antiplatelet therapy within one week of focused ultrasound procedure or drugs known to increase risk or hemorrhage within one month of focused ultrasound procedure
9. Active or suspected acute or chronic uncontrolled infection
10. History of immunocompromise including those who are HIV positive
11. History of intracranial hemorrhage
12. Cerebrovascular disease
13. Subjects with uncontrolled symptoms and signs of increased intracranial pressure
14. Presence of any other neurodegenerative disease such as Parkinson-plus syndromes suspected on neurological examination
15. Anyone suspected to have the diagnosis of idiopathic Parkinson's disease
16. Presence of significant cognitive impairment
17. Subjects with life-threatening systemic disease
18. Subjects with a history of seizures within the past year
19. Subjects with presence or history of psychosis. Subjects with significant or active mood disorders including depression
20. Subjects with risk factors for intraoperative or postoperative bleeding
21. Subjects with brain tumors
22. Pregnancy or lactation
23. Subjects who have had deep brain stimulation or a prior stereotactic ablation of the basal ganglia
24. Subjects who have been administered botulinum toxins for 5 months prior to Baseline
25. Subjects who have an Overall Skull Density Ratio of 0.35 or less as calculated from the screening CT

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazumichi Yamada

Organization

Kumamoto University Hospital

Division name

Division of Functional Neurosurgery

Zip code


Address

1-1-1, Honjo, Chuo-Ku, Kumamoto

TEL

096-373-5219

Email

yamadakazu@fc.kuh.kumamoto-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yu-ichi Tsutsumi

Organization

Hokuto Hospital

Division name

Employee Relations Division

Zip code


Address

7-5, Kisen, Inada-machi, Obihiro City, Hokkaido

TEL

0155488000

Homepage URL

http://www.hokuto7.or.jp/

Email

tsutsumi@hokuto7.or.jp


Sponsor or person

Institute

Departments of Neurology and Neurosurgery,
Hokuto Hospital

Institute

Department

Personal name



Funding Source

Organization

InSightec

Organization

Division

Category of Funding Organization

Outside Japan

Nationality of Funding Organization

Isurael


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2017 Year 01 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2015 Year 02 Month 09 Day

Date of IRB


Anticipated trial start date

2015 Year 03 Month 01 Day

Last follow-up date

2016 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 08 Month 16 Day

Last modified on

2016 Year 08 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027204


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name