Unique ID issued by UMIN | UMIN000015800 |
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Receipt number | R000018386 |
Scientific Title | Clinical trial on effectiveness and safty of Exablate MRgFU thalamotomy for medically intractable essential tremor: ET002J |
Date of disclosure of the study information | 2014/12/03 |
Last modified on | 2021/06/06 11:22:25 |
Clinical trial on effectiveness and safty of Exablate MRgFU thalamotomy for medically intractable essential tremor: ET002J
Exablate MRgFU thalamotomy for essential tremor
Clinical trial on effectiveness and safty of Exablate MRgFU thalamotomy for medically intractable essential tremor: ET002J
Exablate MRgFU thalamotomy for essential tremor
Japan |
essential tremor
Neurology | Neurosurgery |
Others
NO
To evaluate A feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial MR Guided Focused Ultrasound for Unilateral Thalamotomy in the Treatment of Essential Tremor
Safety,Efficacy
tremor improvement and evaluation of advers effect 1 year after treatment
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Device,equipment |
Focused untrasound
22 | years-old | <= |
Not applicable |
Male and Female
intractable to medical treatment
not suitable for surgical intervention due to bleeding tendency etc
previous intracranial operation
13
1st name | Takaomi |
Middle name | |
Last name | Taira |
Tokyo Women's Medical University
Department of Neurosurgery
1628666
8-1 Kawada, Shinjuku, Tokyo 1628666, Japan
0333538111
ttaira@twmu.ac.jp
1st name | Takaomi |
Middle name | |
Last name | Taira |
Tokyo Women's Medical University
Department of Neurosurgery
1628666
8-1 Kawada, Shinjuku, Tokyo 1628666, Japan
0333538111
ttaira@twmu.ac.jp
Tokyo Women's Medical University
Shin-yurigaoka general hospital
Insightec
Other
Tokyo WOmen's Medical University
8-1 Kawada, Shinjuku, Tokyo Japan
0333538111
ttaira@twmu.ac.jp
YES
ET002J
Insightec
2014 | Year | 12 | Month | 03 | Day |
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=
Published
https://academic.oup.com/neurosurgery/article-abstract/88/4/751/6104449
35
The mean skull density ratio (SDR) was 0.47. There was a significant decrease in the mean postural tremor score of the treated hand from baseline to 12 mo by 56.4% (95% CI: 46.7%-66.1%; P < .001), which was maintained at last follow-up. Quality of life improved by 46.3% (mean overall Questionnaire for Essential Tremor score of 17.4 [95% CI: 12.1-22.7]) and there were no severe adverse events. The most frequent adverse event was gait disturbance and all events resolved.
2021 | Year | 06 | Month | 06 | Day |
2021 | Year | 01 | Month | 19 | Day |
Medically intractable essential tremor
recruiting patients
screening
treatment
follow-up to 12 months
transient hypotonia, dysesthesia
Clinical rating scale for tremor, etc
Completed
2014 | Year | 10 | Month | 30 | Day |
2014 | Year | 10 | Month | 30 | Day |
2015 | Year | 01 | Month | 10 | Day |
2017 | Year | 12 | Month | 31 | Day |
2018 | Year | 03 | Month | 31 | Day |
2018 | Year | 03 | Month | 31 | Day |
2018 | Year | 03 | Month | 31 | Day |
2014 | Year | 12 | Month | 01 | Day |
2021 | Year | 06 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018386
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