UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000056121
Receipt number R000064125
Scientific Title Centrifugal Effects of Voluntary Movements on Sensory Evoked Potentials of Different Modalities
Date of disclosure of the study information 2024/11/15
Last modified on 2024/12/11 14:03:14

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Basic information

Public title

Centrifugal Effects of Voluntary Movements on Sensory Evoked Potentials of Different Modalities

Acronym

Centrifugal Effects of Voluntary Movements on Sensory Evoked Potentials of Different Modalities

Scientific Title

Centrifugal Effects of Voluntary Movements on Sensory Evoked Potentials of Different Modalities

Scientific Title:Acronym

Centrifugal Effects of Voluntary Movements on Sensory Evoked Potentials of Different Modalities

Region

Japan


Condition

Condition

healthy adults

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to measure SEPs and AEPs in humans and to determine the effect of centrifugal effects on the long latency components.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Difference effects of centrifugal mechanism between SEPs and AEPs

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

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

electrical stimuli, pure tone stimuli
EEG

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

25 years-old >=

Gender

Male and Female

Key inclusion criteria

healthy adults

Key exclusion criteria

physiological and psychological disorders

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Taiki
Middle name
Last name Makibuchi

Organization

Niigata University of health and welfare

Division name

Major in helth and welfare

Zip code

950-3198

Address

Niigata 950-3198, Japan

TEL

07026216054

Email

hwd24013@nuhw.ac.jp


Public contact

Name of contact person

1st name Taiki
Middle name
Last name Makibuchi

Organization

Niigata University of Health and Welfare

Division name

Major in helth and welfare

Zip code

950-3198

Address

Niigata 950-3198, Japan

TEL

07026216054

Homepage URL


Email

hwd24013@nuhw.ac.jp


Sponsor or person

Institute

Niigata University of Health and Welfare

Institute

Department

Personal name



Funding Source

Organization

Niigata University of Health and Welfare

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Niigata University of Health and Welfare

Address

Niigata 950-3198, Japan

Tel

025-257-4500

Email

hwd24013@nuhw.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

2024 Year 11 Month 15 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


Results date posted


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

Preinitiation

Date of protocol fixation

2024 Year 11 Month 15 Day

Date of IRB

2024 Year 12 Month 07 Day

Anticipated trial start date

2025 Year 01 Month 01 Day

Last follow-up date

2025 Year 08 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2024 Year 11 Month 11 Day

Last modified on

2024 Year 12 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064125