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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000017590
Receipt No. R000020381
Scientific Title Elucidating neurophysiological mechanisms underlying effects of motor training and non-invasive brain stimulation on focal hand dystonia
Date of disclosure of the study information 2015/05/15
Last modified on 2018/05/17

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Basic information
Public title Elucidating neurophysiological mechanisms underlying effects of motor training and non-invasive brain stimulation on focal hand dystonia
Acronym Effects of transcranial stimulation on pathophysiology of focal dystonia
Scientific Title Elucidating neurophysiological mechanisms underlying effects of motor training and non-invasive brain stimulation on focal hand dystonia
Scientific Title:Acronym Effects of transcranial stimulation on pathophysiology of focal dystonia
Region
Japan

Condition
Condition Focal dystonia
Classification by specialty
Neurology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of the present study is to assess effects of a combination of bimanual motor training and bi-hemispheric transcranial direct current stimulation over motor cortices on neural mechanisms responsibly for sensorimotor functions in musicians with focal hand dystonia. We also aim to determine predictors of inter-individual differences in effects of the training across the patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes - Motor-evoked potential elicited by a single-pulse transcranial magnetic stimulation (TMS)
- Short intracortical inhibition and facilitation derived from double-pulse TMS
- Structural and functional images of human brain using a magnetic resonance imaging (MRI)
- Musical Instrument Digital Interface (MIDI)
- Hand kinematics
Key secondary outcomes - Personal traits evaluated by questionnaires
- Resting state network derived from fMRI

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Device,equipment
Interventions/Control_1 trancranial direct current stimulation and motor retraining for 30 min
Interventions/Control_2 trancranial direct current stimulation for 30 seconds (sham stimulation) and motor retraining for 30 min
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
20 years-old <=
Age-upper limit
60 years-old >=
Gender Male and Female
Key inclusion criteria - A history of musical training for more than 15 years with professional education in musical conservatory
- No metal implant due to surgery
- No history of epilepsy
- No prescription of medication for sleep-aid
- No risk of claustrophobia
- A person with an ability to understand explanation of the experimental contents and to make a decision concerning participation in the experiment
- No history of taking GABA-related medications within 6 months prior to starting the experiment
Key exclusion criteria - Bilateral dystonia
- Cardiovascular diseases
- Uncontrollable hypertension
- Neither psychiatric nor neurological disorders except for focal hand dystonia
- Acute disease affecting the whole body and high fever
- Recent disease of the lungs
- Serious disorder of liver and renal function
- Serious orthopedic disorders
- Serious cognitive and psychiatric disorders
- Abnormal metabolic process
- Implantation of metal devises such as pace makers, cochlear implant, and shunts
- Pregnancy
- A history of epileptic attacks
- Intracranial pathology
- A history of taking medications for lowering thresholds of cramping
- Alcohol dependence
- Serious cardiac disorder
- Auditory functional abnormalities and tinnitus
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Hanakawa
Organization National Center of Neurology and Psychiatry
Division name Integrative Brain Imaging Center
Zip code
Address 4-1-1 Kodaira-Higashi, Kodaira, Tokyo, Japan 1878551
TEL 042-346-2206
Email hanakawa@ncnp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinichi Furuya
Organization Sophia University
Division name Musical Skill and Injury Center
Zip code
Address 4-4 Chiyodaku Tokyo Japan 1020081
TEL 03-3238-8575
Homepage URL
Email sfuruya@sophia.ac.jp

Sponsor
Institute National Center of Neurology and Psychiatry
Institute
Department

Funding Source
Organization Japan Society for Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
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 05 Month 15 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2015 Year 01 Month 30 Day
Date of IRB
Anticipated trial start date
2015 Year 05 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 05 Month 15 Day
Last modified on
2018 Year 05 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020381

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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