UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035059
Receipt number R000039867
Scientific Title The differential effects of vestibular simulations between neck flexion and extension on cerebral autoregulation
Date of disclosure of the study information 2018/11/28
Last modified on 2021/02/19 10:00:30

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

The differential effects of vestibular simulations between neck flexion and extension on cerebral autoregulation

Acronym

The differential effects of vestibular simulations between neck flexion and extension on cerebral autoregulation

Scientific Title

The differential effects of vestibular simulations between neck flexion and extension on cerebral autoregulation

Scientific Title:Acronym

The differential effects of vestibular simulations between neck flexion and extension on cerebral autoregulation

Region

Japan


Condition

Condition

Healthy adult volunteers

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose is to investigate the differential effects of vestibular simulations between neck flexion and extension on cerebral autoregulation.

Basic objectives2

Others

Basic objectives -Others

physiological changes

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Gain, coherence and phase between arterial blood pressure and cerebral blood flow during 6-min neck extension and 6-min neck flexion

Key secondary outcomes

Cerebral blood flow velocity, pulsatility index, blood pressure variability, respiratory indexes, intracranial pressure, baroreflex, heart rate variability


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

6-min neck flexion in a sitting position

Interventions/Control_2

6-min neck extension in a sitting position

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Healthy adults consented to participate in the study

Key exclusion criteria

Not satisfy selection criteria noted above.

Target sample size

16


Research contact person

Name of lead principal investigator

1st name Kenichi
Middle name
Last name Iwasaki

Organization

Nihon University School of Medicine

Division name

Division of Hygiene, Department of Social Medicine

Zip code

173-8610

Address

30-1, Oyaguchi-Kamicho, Itabashi-ku, Tokyo

TEL

03-3972-8111

Email

iwasaki.kenichi@nihon-u.ac.jp


Public contact

Name of contact person

1st name Tomokazu
Middle name
Last name Kato

Organization

Nihon University School of Medicine

Division name

Division of Hygiene, Department of Social Medicine

Zip code

173-8610

Address

30-1, Oyaguchi-Kamicho, Itabashi-ku, Tokyo

TEL

0339728111

Homepage URL


Email

kato.tomokazu@nihon-u.ac.jp


Sponsor or person

Institute

Division of Hygiene, Department of Social Medicine, Nihon University School of Medicine

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

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Nihon University School of Medicine

Address

30-1, Oyaguchi-Kamicho, Itabashi, Tokyo

Tel

03-3972-8111

Email

med.kenjim@nihon-u.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

日本大学医学部(東京都)


Other administrative information

Date of disclosure of the study information

2018 Year 11 Month 28 Day


Related information

URL releasing protocol

https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000039867&ty

Publication of results

Partially published


Result

URL related to results and publications

https://kuleuvencongres.be/icp2019/141-kato-tomokazu-b.pdf

Number of participants that the trial has enrolled

15

Results

Arterial blood pressure (ABP) and cerebral blood flow velocity were measured during neck flexion and extension in the sitting position.
Mean ABP variability in the low frequency range increased significantly during both neck flexion and extension compared with the upright head position; however, no changes in the transfer function gain were seen in that range.
The present results suggest that dynamic cerebral autoregulation may be maintained during neck flexion and extension in healthy adults.

Results date posted

2020 Year 04 Month 18 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

15 healthy adults, ages 23(2)yr; height 170(4) cm; weight 64(6)kg; mean(SD)

Participant flow

After explanation of this study to candidates by recruitment with the poster, all participants provided written informed consent as well as a medical history regarding circulation and were screened based on a physical examination including electrocardiography and blood pressure measurements. Exclusion criteria comprised failure to obtain CBF velocity signals in the right middle cerebral artery by transcranial Doppler ultrasonography.

Adverse events

None

Outcome measures

Arterial blood pressure (ABP)
Cerebral blood flow velocity (CBFV)
Mean ABP variability
Mean CBFV variability
Transfer function gain between mean ABP variability and mean CBFV variability.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 09 Month 18 Day

Date of IRB

2018 Year 09 Month 18 Day

Anticipated trial start date

2018 Year 11 Month 28 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry

2020 Year 08 Month 31 Day

Date trial data considered complete

2020 Year 08 Month 31 Day

Date analysis concluded

2020 Year 08 Month 31 Day


Other

Other related information



Management information

Registered date

2018 Year 11 Month 28 Day

Last modified on

2021 Year 02 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039867


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name