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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010714
Receipt No. 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

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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
Institute Tokyo Women's Medical University
Shin-yurigaoka General Hospital
Institute
Department

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
URL(English) https://upload.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


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