UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000034007
Receipt No. R000038777
Scientific Title Corticospinal excitability affected by conflicting visual and proprioceptive information
Date of disclosure of the study information 2018/09/05
Last modified on 2020/09/06 (Ver. 6)

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Basic information
Public title Corticospinal excitability affected by conflicting visual and proprioceptive information
Acronym Corticospinal excitability affected by conflicting multisensory information
Scientific Title Corticospinal excitability affected by conflicting visual and proprioceptive information
Scientific Title:Acronym Corticospinal excitability affected by conflicting multisensory information
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 determine whether conflicting visual and proprioceptive information affects the corticospinal excitability and kinesthesia.
Basic objectives2 Others
Basic objectives -Others This study investigates change in motor evoked potentials by visual and vibratory stimulations.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Motor evoked potentials of the flexor and extensor carpi radialis muscles are recorded during vibratory stimulation over the extensor carpi radialis muscle. In addition, illusory percept of flexion movement is also assessed during vibratory stimulation.
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
Interventions/Control_1 Subjects were seated wirh their hands and forearms resting on a pillow on the desk. For 25 scalp position, 5 transcranial magnetic stimulation of 120 percent of the resting motor threshold is delivered to compute center of gravity (hot spot in M1) of the flexor and extensor carpi radialis muscles. Then, subjects observe a hand action depicted on a computer screen during vibratory stimulation over the extensor carpi radialis muscle (amplitude 1.0 mm, frequency 80 Hz cycle duration of 5 min: 10s on, 52 off). In addition, 60 transcranial magnetic stimulation of 120 percent of the extensor carpi radialis muscle's resting motor threshold is delivered at the midpoint between the center of gravities of the flexor and extensor carpi radialis muscles (interstimulus interval: 10 s) during vibratory stimulation.
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 are 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 Prifectual University
Division name School of Health Sciences
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 Sciences
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
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics Committee of the Saitama Prefectural Univercity
Address 820 Sannomiya, Koshigaya City Saitama
Tel 048-971-0500
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
2018 Year 09 Month 05 Day

Related information
URL releasing protocol https://www.frontiersin.org/articles/10.3389/fnint.2019.00063/full
Publication of results Published

Result
URL related to results and publications https://www.frontiersin.org/articles/10.3389/fnint.2019.00063/full
Number of participants that the trial has enrolled 20
Results 
The ECR motor evoked potential (MEP) amplitudes significantly increased in the control condition compared to the resting condition (p<0.0001), whereas the FCR MEP amplitudes did not change between the resting and control conditions. The ECR MEP amplitudes significantly increased in the static condition compared to the dynamic condition (p<0.0001)
. On the other hand, the FCR MEP amplitudes significantly increased in the dynamic condition compared to the static condition (p<0.0001).
Results date posted
2020 Year 09 Month 06 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
No participant had risks of adverse events from TMS or use of medications or any psychiatric or neurological diseases.
Participant flow 
Subjects who voluntarily participated in the public offering were asked to provide oral and written informed consent.
Adverse events 
None
Outcome measures 
Motor evoked potentials of the flexor and extensor carpi radialis muscles were recorded immediately after stimulated by vibratory or movie observation over the 4 experiment's conditions.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 07 Month 01 Day
Date of IRB
2017 Year 11 Month 30 Day
Anticipated trial start date
2018 Year 09 Month 05 Day
Last follow-up date
2019 Year 03 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 09 Month 03 Day
Last modified on
2020 Year 09 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038777