UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052448 |
|---|---|
| Receipt number | R000059863 |
| Scientific Title | Investigation of functional interaction of hand muscles: a study using F-wave, MEPs and EEGs |
| Date of disclosure of the study information | 2023/10/10 |
| Last modified on | 2024/04/11 20:35:58 |
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Basic information
Public title
Investigation of functional interaction of hand muscles: a study using F-wave, MEPs and EEGs
Acronym
Investigation of interaction of hand muscles
Scientific Title
Investigation of functional interaction of hand muscles: a study using F-wave, MEPs and EEGs
Scientific Title:Acronym
Investigation of interaction of hand muscles
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The activity of the cerebral cortex exhibits oscillatory activities even during rest, and motor-evoked potentials (MEPs) obtained by transcranial magnetic stimulation (TMS) of the primary motor cortex (M1) show significant amplitude variability with each stimulus. While the neural basis for this phenomenon remains incompletely elucidated, it is hypothesized to be related to brain activity, and attempts have been made to predict MEP responses by evaluating pre-TMS EEG activity. We previously reported a correlation between the amplitude of alpha to beta frequency band EEGs and MEP amplitudes. However, this predictive relationship appears weak, suggesting the unknown factors. Furthermore, hand intrinsic muscles contribute to complex fine motor control either cooperatively or individually, but the influence of cerebral cortex activity on these hand intrinsic muscle groups remains unclear.
In this research plan, we aim to comprehensively understand the neural basis governing the excitability of hand intrinsic muscle groups. Specifically, we will assess whether multiple hand intrinsic muscles activate cooperatively or reflect spinal cord excitability through F-waves, investigate the relationship between MEPs and EEGs.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation of F-wave, MEPs among intrinsic hand muscles. Correlations between EEGs and F-waves or MEPs.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Electrical stimulation for F-waves, Transcranial magnetic stimulation for MEPs
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults
Key exclusion criteria
History of neurological disorders
History of seizures
Implantation of metalic devices influenced by TMS
Pregnant woman
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Katsuya |
| Middle name | |
| Last name | Ogata |
Organization
International University of Health and Welfare
Division name
Department of Pharmacy,School of Pharmaceutical Sciences at Fukuoka
Zip code
831-8501
Address
Enokizu 137-1, Okawa, Fukuoka
TEL
0944-89-2000
ogata_k@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Katsuya |
| Middle name | |
| Last name | Ogata |
Organization
International University of Health and Welfare
Division name
Department of Pharmacy,School of Pharmaceutical Sciences at Fukuoka
Zip code
831-8501
Address
Enokizu 137-1, Okawa, Fukuoka
TEL
0944-89-2000
Homepage URL
ogata_k@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
OGATA, Katsuya
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare
Address
Enokizu 137-1, Okawa, Fukuoka
Tel
0944-89-2000
ogata_k@iuhw.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
国際医療福祉大学(福岡県)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | Month | 10 | 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
There was little correlation of F-wave amplitudes among intrinsic hand muslces
MEP amplitudes were relatively correlated compared with F-waves.
Results date posted
| 2023 | Year | 10 | Month | 09 | Day |
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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Collecting data is ongoing
Management information
Registered date
| 2023 | Year | 10 | Month | 09 | Day |
Last modified on
| 2024 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059863
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
