UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016590 |
|---|---|
| Receipt number | R000019251 |
| Scientific Title | Feasibility study to evaluate the safety and effectiveness of magnetic resonance guided focused ultrasound (MRgFUS) ablation of the ventrooralis (Vo) nucleus of the thalamus for the treatment of focal hand dystonia (e.g., musician's focal dystonia and/or writer's cramp) |
| Date of disclosure of the study information | 2015/02/23 |
| Last modified on | 2021/06/06 11:38:47 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Feasibility study to evaluate the safety and effectiveness of magnetic resonance guided focused ultrasound (MRgFUS) ablation of the ventrooralis (Vo) nucleus of the thalamus for the treatment of focal hand dystonia (e.g., musician's focal dystonia and/or writer's cramp)
Acronym
MR guided focused ultrasound treatment for focal hand dystonia
Scientific Title
Feasibility study to evaluate the safety and effectiveness of magnetic resonance guided focused ultrasound (MRgFUS) ablation of the ventrooralis (Vo) nucleus of the thalamus for the treatment of focal hand dystonia (e.g., musician's focal dystonia and/or writer's cramp)
Scientific Title:Acronym
MR guided focused ultrasound treatment for focal hand dystonia
Region
| Japan |
Condition
Condition
Focal Hand Dystonia (Musician's Focal Dystonia and/or Writer's Cramp, etc)
Classification by specialty
| Neurology | Neurosurgery | Operative medicine |
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The proposed study prospective, single arm, single-blind (site rater ) study, is to evaluate the safety and initial effectiveness of the ExAblate Transcranial MRgFUS treatment of patients suffering from disabling FHD by unilateral lesioning the contralateral thalamic Vo.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tubiana Scale.
Writers Cramp Rating Scale
Video-clips
Key secondary outcomes
Arm Dystonia Disability Scale (ADDS)
Modified QUEST for FHD
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Focused ultrasound
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
Patients with focal hand dystonia which is intractable to conventional conservative treatment
Key exclusion criteria
not suitable conditions for surgical intervention
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Takaomi |
| Middle name | |
| Last name | Taira |
Organization
Tokyo Women's Medical University
Division name
Department of Neurosurgery
Zip code
1628666
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL
03-3353-8111
ttaira@twmu.ac.jp
Public contact
Name of contact person
| 1st name | Shiro |
| Middle name | |
| Last name | Horisawa |
Organization
Tokyo Women's Medical University
Division name
Department of Neurosurgery
Zip code
1628666
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL
03-3353-8111
Homepage URL
neurosurgery0222@gmail.com
Sponsor or person
Institute
Tokyo Women's Medical University
Shin-yurigaoka general hospital
Institute
Department
Personal name
Funding Source
Organization
FUS foundation in USA
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Women's Medical University
Address
8-1, Kawada, Shinjuku, Tokyo 1628666
Tel
03-3353-8111
ttaira@twmu.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
FHD001
Org. issuing International ID_1
FUS foundation
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 23 | Day |
Related information
URL releasing protocol
https://movementdisorders.onlinelibrary.wiley.com/doi/full/10.1002/mds.28613
Publication of results
Published
Result
URL related to results and publications
https://movementdisorders.onlinelibrary.wiley.com/doi/full/10.1002/mds.28613
Number of participants that the trial has enrolled
10
Results
We show that MRgFUS Vo-thalamotomy significantly improved FHD.
Results date posted
| 2021 | Year | 06 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 05 | Month | 29 | Day |
Baseline Characteristics
Medically intractable focal hand dystonia
Participant flow
recruiting patients
screening
treatment
Follow-up up to 12 months
Adverse events
transient hypotonia
Outcome measures
focal hand dystonia rating scale
Tubiana scale
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 03 | Month | 20 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 20 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 20 | Day |
Last modified on
| 2021 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019251
