UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017590 |
|---|---|
| Receipt number | 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 09:22:55 |
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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
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
sfuruya@sophia.ac.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020381
