UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037082
Receipt number R000042253
Scientific Title Influence of pain-related fear on EEG activity
Date of disclosure of the study information 2019/07/01
Last modified on 2019/06/16 14:09:32

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Basic information

Public title

Influence of pain-related fear on EEG activity

Acronym

Influence of pain-related fear on EEG activity

Scientific Title

Influence of pain-related fear on EEG activity

Scientific Title:Acronym

Influence of pain-related fear on EEG activity

Region

Japan


Condition

Condition

Healthy volunteer

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Recording the EEG activity under the condition of pain-related fear.

Basic objectives2

Others

Basic objectives -Others

clarifying mechanism

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

EEG activity

Key secondary outcomes

autonomic response


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

40 years-old >=

Gender

Male and Female

Key inclusion criteria

without brain injury

Key exclusion criteria

with brain injury

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Osumi
Middle name
Last name Michihiro

Organization

Kio university

Division name

Health science

Zip code

635-0832

Address

4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara

TEL

0745-54-1601

Email

m.ohsumi@kio.ac.jp


Public contact

Name of contact person

1st name Osumi
Middle name
Last name Michihiro

Organization

Kio university

Division name

Health Science

Zip code

635-0832

Address

4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara

TEL

0745-54-1601

Homepage URL


Email

m.ohsumi@kio.ac.jp


Sponsor or person

Institute

Kio University

Institute

Department

Personal name



Funding Source

Organization

Kio University

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

Kio University

Address

4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara

Tel

0745-54-1601

Email

m.ohsumi@kio.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 07 Month 01 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

2019 Year 06 Month 30 Day

Date of IRB


Anticipated trial start date

2019 Year 07 Month 01 Day

Last follow-up date

2023 Year 07 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Nothing especially


Management information

Registered date

2019 Year 06 Month 16 Day

Last modified on

2019 Year 06 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042253


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name