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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000016590
Receipt No. 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

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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
Email 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
Email neurosurgery0222@gmail.com

Sponsor
Institute Tokyo Women's Medical University
Shin-yurigaoka general hospital
Institute
Department

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
Email 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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019251

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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