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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000019498
Receipt No. R000021781
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 2015/10/27
Last modified on 2018/05/11

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

Condition
Condition Medication Refractory Essential Tremor
Classification by specialty
Neurology Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this prospective, multi-site, single-arm study is to test the efficacy of treatment using the ExAblate Transcranial System and to further demonstrate safety in medication-refractory tremor in subjects with essential tremor (ET).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Safety: To evaluate the incidence and severity of adverse events (AE/AEs) associated with ExAblate Transcranial MRgFUS treatment of medication-refractory ET
Effectiveness: To determine the effectiveness of the ExAblate Transcranial MRgFUS treatment of medication-refractory tremor (i.e. ET). Efficacy will be determined utilizing the Clinical Rating Scale for Tremor (CRST) in ET from examinations at baseline and 3-Months post-ExAblate treatment.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 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 in subjects with essential tremor (ET).
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. 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).
7. 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.
8. Able to communicate sensations during the ExAblate TcMRgFUS treatment
9. 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.
10. May have bilateral appendicular tremor
11. 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])
12. Inclusion and exclusion criteria have been agreed upon by two members of the medical team.
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 or who is on dialysis
7. History of abnormal bleeding or coagulopathy.
8. Receiving anticoagulant or antiplatelet therapy within one week, or drugs 9. Active or suspected acute or chronic uncontrolled infection
10. History of immunocompromise.
11. History of intracranial hemorrhage
12. Cerebrovascular disease
13. Subjects with uncontrolled symptoms and signs of increased intracranial pressure.
14. Individuals who are not able or willing to tolerate the required prolonged stationary supine position.
15. Are participating or have participated in another clinical trial
16. Significant claustrophobia
17. Subjects unable to communicate.
18. Presence of any other neurodegenerative disease such as Parkinson plus syndromes
19. Anyone suspected to have the diagnosis of idiopathic Parkinson's disease.
20. Presence of significant cognitive impairment
21. Subjects with life threatening systemic disease
22. Subjects with a history of seizures
23. Subjects with presence or history of psychosis or active mood disorders will be excluded.
24. Subjects with risk factors for intraoperative or postoperative bleeding.
25. Subjects with brain tumors
26. Pregnancy or lactation.
27. Legal incapacity or limited legal capacity.
28. Subjects who have had deep brain stimulation or a prior stereotactic ablation of the basal ganglia
29. Subjects who have been administered botulinum toxins
30. Subjects who have an Overall Skull Density Ratio of 0.3 or less as calculated from the screening CT.
31. Any illness that in the investigator's opinion preclude participation in this study.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Haruhiko Kishima
Organization Osaka University School of Medicine
Division name Department of Neurosurgery
Zip code
Address 2-2 Yamadaoka,Suita,Osaka 565-0871,Japan
TEL 06-6879-3652
Email yoshimine@nsurg.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoru Oshino
Organization Osaka University School of Medicine
Division name Department of Neurosurgery
Zip code
Address 2-2 Yamadaoka,Suita,Osaka 565-0871,Japan
TEL 06-6879-3652
Homepage URL
Email hkishima@nsurg.med.osaka-u.ac.jp

Sponsor
Institute Department of Neurosurgery, Osaka University School of Medicine
Institute
Department

Funding Source
Organization InSightec Japan
Organization
Division
Category of Funding Organization Profit organization
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 NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 大阪大学医学部付属病院(大阪府)、彩都友紘会病院(大阪府)

Other administrative information
Date of disclosure of the study information
2015 Year 10 Month 27 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 Main results already published
Date of protocol fixation
2015 Year 06 Month 29 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 30 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
2017 Year 08 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 10 Month 26 Day
Last modified on
2018 Year 05 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021781

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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