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

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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 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

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

Value
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