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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023639
Receipt No. 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

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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
Institute Departments of Neurology and Neurosurgery,
Hokuto Hospital
Institute
Department

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
URL(English) https://upload.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


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