UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033752
Receipt number R000038312
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 2018/09/01
Last modified on 2020/03/02 18:33:28

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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

ET002J

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

ET002J

Region

Japan


Condition

Condition

Medication Refractory Essential Tremor

Classification by specialty

Neurology Neurosurgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The efficacy of treatment and to further demonstrate safety for the medication Refractory Essential Tremor.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase III


Assessment

Primary outcomes

The efficacy of treatment using the ExAblate Transcranial
System and to further demonstrate safety.

Key secondary outcomes

1. Quality life claims : Questionnaire for Essential Tremor ( QUEST ) outcome (upper extremity questions ) at Month 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 througu Month12 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

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, 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).

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Men and women age 20 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 Tetsumasa
Middle name
Last name Kamei

Organization

Medical Corporation Tokushukai Shonanfujisawa Tokushukai Hospital

Division name

neurology department

Zip code

2510041

Address

1-5-1,Kandai,Tsujido,Fujisawa,Kanagawa

TEL

0466-35-1177

Email

tetsumasakam@ctmc.jp


Public contact

Name of contact person

1st name Etsuko
Middle name
Last name Shimizu

Organization

Medical Corporation Tokushukai Shonanfujisawa Tokushukai Hospital

Division name

Clinical Research Center

Zip code

2510041

Address

1-5-1,Kandai,Tsujido,Fujisawa,Kanagawa

TEL

0466-35-1177

Homepage URL


Email

etsuko.shmizu@tokushhukai.jp


Sponsor or person

Institute

Medical Corporation Tokushukai Shonanfujisawa Tokushukai Hospital

Institute

Department

Personal name



Funding Source

Organization

InSightec

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

Tokushukai group EC

Address

1-8-7 Koji-machi,Chiyouda-ku,Tokyo

Tel

0332634801

Email

etsuko.shimizu@tokushukai.jp


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

2018 Year 09 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

10

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

2016 Year 11 Month 07 Day

Date of IRB

2017 Year 01 Month 18 Day

Anticipated trial start date

2017 Year 01 Month 19 Day

Last follow-up date

2024 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

2018 Year 08 Month 14 Day

Last modified on

2020 Year 03 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038312


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name