UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057897 |
|---|---|
| Receipt number | R000065694 |
| Scientific Title | The role of skill training in the relationship between the globus pallidal volume and GABA concentration: A cross-sectional multimodal MRI study |
| Date of disclosure of the study information | 2025/05/26 |
| Last modified on | 2025/05/18 17:08:45 |
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Basic information
Public title
An MRI study on the relationship between skill training and GABA Concentration
Acronym
Investigation of the relationship between skill training and GABA in the brain
Scientific Title
The role of skill training in the relationship between the globus pallidal volume and GABA concentration: A cross-sectional multimodal MRI study
Scientific Title:Acronym
Skill training and the globus pallidal GABA-volume relationship
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether the volume of the globus pallidus correlates with its GABA concentration.
Basic objectives2
Others
Basic objectives -Others
To investigate whether greater time spent on skill training is associated with increased pallidal volume and higher GABA concentration.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Globus pallidal volume measured by MRI and globus pallidal GABA concentration measured by 1H-MRS.
Key secondary outcomes
Skill training information (music training history survey, the Goldsmiths Musical Sophistication Index score, the Barcelona Music Reward Questionnaire score), cognitive function (Japanese Adult Reading Test (JART), Letter Number Sequencing (LNS), Stroop Test, Trail Making Test (TMT)), and motor function (Simpson-Angus Scale, Barnes Akathisia Rating Scale, Abnormal Involuntary Movement Scale).
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Individuals who were 18 years of age or older at the time of obtaining consent
(2) No history of psychiatric disorders
Key exclusion criteria
(1) Substance-related disorders within the past 6 months
(2) Contraindications to undergoing MRS, such as metallic implants, pacemakers, or claustrophobia
(3) Severe or unstable physical illness
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | Shinichiro |
| Middle name | |
| Last name | Nakajima |
Organization
Keio University
Division name
School of Medicine
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3611
shinichiro.l.nakajima@gmail.com
Public contact
Name of contact person
| 1st name | Shinichiro |
| Middle name | |
| Last name | Nakajima |
Organization
Keio University
Division name
School of Medicine
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3611
Homepage URL
shinichiro.l.nakajima@gmail.com
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Grant in Aid for Scientific Research (B), Osake-no-Kagaku Foundation, Grant in Aid for Scientific Research (C)
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
Keio University
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel
03-5363-3611
medwww@info.keio.ac.jp
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
| 2025 | Year | 05 | Month | 26 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 05 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 05 | Month | 26 | Day |
Last follow-up date
| 2027 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Thirty-two musicians and thirty-two healthy controls will be recruited, and GABA concentrations in the globus pallidus will be measured using 7T MRS.
Management information
Registered date
| 2025 | Year | 05 | Month | 18 | Day |
Last modified on
| 2025 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065694
