UMIN-CTR Clinical Trial

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
Email	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
Email	suzuki-takako@spu.ac.jp

Sponsor
Institute	Saitama Prefectural University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041912