Unique ID issued by UMIN | UMIN000033752 |
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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 |
A Study to Evaluate the Effectiveness and Safety of ExAblate Transcranial MRgFUS Thalamotomy Treatment of Medication Refractory Essential Tremor Subjects
ET002J
A Study to Evaluate the Effectiveness and Safety of ExAblate Transcranial MRgFUS Thalamotomy Treatment of Medication Refractory Essential Tremor Subjects
ET002J
Japan |
Medication Refractory Essential Tremor
Neurology | Neurosurgery |
Others
NO
The efficacy of treatment and to further demonstrate safety for the medication Refractory Essential Tremor.
Safety,Efficacy
Phase III
The efficacy of treatment using the ExAblate Transcranial
System and to further demonstrate safety.
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Self control
1
Treatment
Device,equipment |
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).
20 | years-old | <= |
Not applicable |
Male and Female
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.
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.
10
1st name | Tetsumasa |
Middle name | |
Last name | Kamei |
Medical Corporation Tokushukai Shonanfujisawa Tokushukai Hospital
neurology department
2510041
1-5-1,Kandai,Tsujido,Fujisawa,Kanagawa
0466-35-1177
tetsumasakam@ctmc.jp
1st name | Etsuko |
Middle name | |
Last name | Shimizu |
Medical Corporation Tokushukai Shonanfujisawa Tokushukai Hospital
Clinical Research Center
2510041
1-5-1,Kandai,Tsujido,Fujisawa,Kanagawa
0466-35-1177
etsuko.shmizu@tokushhukai.jp
Medical Corporation Tokushukai Shonanfujisawa Tokushukai Hospital
InSightec
Profit organization
Tokushukai group EC
1-8-7 Koji-machi,Chiyouda-ku,Tokyo
0332634801
etsuko.shimizu@tokushukai.jp
NO
2018 | Year | 09 | Month | 01 | Day |
Unpublished
10
No longer recruiting
2016 | Year | 11 | Month | 07 | Day |
2017 | Year | 01 | Month | 18 | Day |
2017 | Year | 01 | Month | 19 | Day |
2024 | Year | 12 | Month | 31 | Day |
2018 | Year | 08 | Month | 14 | Day |
2020 | Year | 03 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038312
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