UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010714
Receipt number R000012520
Scientific Title A Pivotal 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 2013/06/01
Last modified on 2014/11/21 13:03:55

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Basic information

Public title

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

Acronym

Treatment of essential tremor with focused ultrasound

Scientific Title

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

Scientific Title:Acronym

Treatment of essential tremor with focused ultrasound

Region

Japan Asia(except Japan) North America
Europe


Condition

Condition

Essential tremor

Classification by specialty

Neurology Neurosurgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of treatment using the ExAblate Transcranial System and to further demonstrate safety in medication-refractory tremor in subjects with essential tremor

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Tremor improvement and evaluation of advers effect 12 months after treatment

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit


Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Focused ultrasound treatment

Interventions/Control_2

Sham treatment

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

A diagnosis of essential tremor by a specialist
Tremor refractory to adequate trials of at least two medications
Significant disability due to essential tremor despite medical treatment

Key exclusion criteria

Unstable cardiac status
Severe hypertension (diastolic BP > 100 on medication)
Standard contraindications for MR imaging
Severely impaired renal function
History of abnormal bleeding and/or coagulopathy
History of intracranial hemorrhage
Infectioous or immunocompromise state
Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment
Presence of any other neurodegenerative disease or Parkinsonism
Presence of significant cognitive impairment as determined with a score &#8804; 24 on the Mini Mental Status Examination

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takaomi Taira

Organization

Tokyo Womnes's Medical University

Division name

Department of Neurosurgery

Zip code


Address

8-1 Kawada, Shinjuku, Tokyo 1628666, Japan

TEL

03-3353-8111

Email

ttaira@nij.twmu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takaomi Taira

Organization

Tokyo Womnes's Medical University

Division name

Department of Neurosurgery

Zip code


Address

8-1 Kawada, Shinjuku, Tokyo 1628666, Japan

TEL

03-3353-8111

Homepage URL


Email

ttaira@nij.twmu.ac.jp


Sponsor or person

Institute

Tokyo Women's Medical University
Shin-yurigaoka General Hospital

Institute

Department

Personal name



Funding Source

Organization

InSightec Ltd.

Organization

Division

Category of Funding Organization

Outside Japan

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

YES

Study ID_1

ET002

Org. issuing International ID_1

Insightec

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

東京女子医科大学病院 脳神経外科
新百合ヶ丘総合病院 脳神経外科


Other administrative information

Date of disclosure of the study information

2013 Year 06 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

2013 Year 05 Month 20 Day

Date of IRB


Anticipated trial start date

2013 Year 08 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 05 Month 14 Day

Last modified on

2014 Year 11 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012520


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name