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 ≤ 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
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
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
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
