UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036780 |
|---|---|
| Receipt number | R000041912 |
| Scientific Title | Interaction between brain activity and reaching trajectory during physical guidance |
| Date of disclosure of the study information | 2019/05/24 |
| Last modified on | 2022/11/29 12:12:32 |
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Basic information
Public title
Interaction between brain activity and reaching trajectory during physical guidance
Acronym
Interaction between brain activity and reaching trajectory during physical guidance
Scientific Title
Interaction between brain activity and reaching trajectory during physical guidance
Scientific Title:Acronym
Interaction between brain activity and reaching trajectory during physical guidance
Region
| Japan |
Condition
Condition
healthy and neurologically intact
adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate relation between brain activity and reaching trajectory during physical guidance.
Basic objectives2
Others
Basic objectives -Others
Electroencephalographic oscillations and coordinates of hand and arm positions.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Electroencephalographic oscillations and coordinates of hand and arm positions are recorded during physical guidance.
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
Subjects are seated with their hands and forearms resting on a pillow on the desk.
Transcranial magnetic stimulation is used to search for the biceps hot spot and to determine the position of the electroencephalographic electrodes. The electrodes are attached to nine places centered on the hot spot. Infrared reflective markers are also attached on participant's right index finger tip, lateral humeral epicondyle, and acromion. In observation condition, participants are asked to observe the first-person perspective video clips, which display elbow flexion and extension movements by physical assistance. In physical guidance condition, the participants are instructed to relax their hand and arm during elbow flexion and extension movements by physical assistance. Each condition comprises 30 trials of 8 movement cycles including elbow flexion and extension.
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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The subjects ate healthy, neurologically intact, right-handed volunteers. In addition, screening shows that none are at risk for adverse events during transcranial magnetic stimulation.
Key exclusion criteria
None
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takako |
| Middle name | |
| Last name | Suzuki |
Organization
Saitama Prefectural University
Division name
School of Health and Social Services
Zip code
3438540
Address
820 Sannomiya, Koshigaya City, Saitama
TEL
048-973-4125
suzuki-takako@spu.ac.jp
Public contact
Name of contact person
| 1st name | Takako |
| Middle name | |
| Last name | Suzuki |
Organization
Saitama Prefectural University
Division name
School of Health and Social Services
Zip code
3438540
Address
820 Sannomiya, Koshigaya City, Saitama
TEL
048-973-4125
Homepage URL
suzuki-takako@spu.ac.jp
Sponsor or person
Institute
Saitama Prefectural University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokyo Kasei University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research ethics committee of the Saitama Prefectural University
Address
820 Sannomiya, Koshigaya City, Saitama
Tel
048-973-4120
shorei@spu.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
| 2019 | Year | 05 | Month | 24 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000041912
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/2076-3425/12/5/647
Number of participants that the trial has enrolled
20
Results
The coherence between high-beta and low-gamma oscillations near the hotspot of the
biceps brachii muscle and passive movement rhythms was higher than that between alpha oscillation and passive movement rhythm.
Results date posted
| 2022 | Year | 11 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy, neurologically intact adults.
Participant flow
All healthy volunteers were enrolled in an experiment.
Adverse events
None.
Outcome measures
Coherence between EEG oscillations and passive movement rhythm.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 05 | Month | 08 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 13 | Day |
Last follow-up date
| 2021 | Year | 09 | 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
| 2019 | Year | 05 | Month | 17 | Day |
Last modified on
| 2022 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041912
