UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034007
Receipt number 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 06:28:57

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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 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


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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038777


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name