UMIN-CTR Clinical Trial

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://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019251