UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022632
Receipt number R000026085
Scientific Title Relationship between stimulus condition and movement of wrist joint on magnetic and electrical stimulation for upper limb
Date of disclosure of the study information 2016/06/07
Last modified on 2023/08/04 08:40:44

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Basic information

Public title

Relationship between stimulus condition and movement of wrist joint on magnetic and electrical stimulation for upper limb

Acronym

Effect of magnetic and electrical stimulation on upper limb

Scientific Title

Relationship between stimulus condition and movement of wrist joint on magnetic and electrical stimulation for upper limb

Scientific Title:Acronym

Effect of magnetic and electrical stimulation on upper limb

Region

Japan


Condition

Condition

Healthy person

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the relationship between stimulus condition and movement of wrist joint on the magnetic and electrical stimulation for upper limb

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The changes of joint angle of wrist

Key secondary outcomes

Pain and discomfort score (numerical rating scale; NRS)


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Magnetic stimulation device and electrical stimulation device are used once in the same day. The stimulation frequency is 30Hz, stimulation time is two seconds per once, and number of times is 4 times per stimulation condition.

Interventions/Control_2

Electrical stimulation device was used once in the same day. The stimulation frequency is 30Hz, stimulation time is two seconds per once, and number of times is 4 times per stimulation condition.

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 person

Key exclusion criteria

User of the medical electrical equipment (pacemaker, pump oxygenator equipment and electrocardiogram), cancer, pregnancy, infectious disease, esthesiodermia or skin abnormality, indistinct intention, acute algetic disease, diabetes, hypothermia, hematogenous disorders

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Izumi
Middle name
Last name Shin-ichi

Organization

Tohoku University

Division name

Department of Physical medicine and Rehabilitation, School of Medicine/ Graduate of School of Biomedical Engineering

Zip code

980-8575

Address

2-1 Seiryo-cho, Aoba-ku, Sendai, Miyagi

TEL

022-717-7338

Email

izmis@med.tohoku.ac.jp


Public contact

Name of contact person

1st name Oyama
Middle name
Last name Hideki

Organization

Tohoku University

Division name

Department of Physical medicine and Rehabilitation, Graduate of School of Biomedical Engineering

Zip code

980-8575

Address

2-1 Seiryo-cho, Aoba-ku, Sendai, Miyagi

TEL

022-717-7338

Homepage URL


Email

oyama@bme.tohoku.ac.jp


Sponsor or person

Institute

School of Medicine, Tohoku University

Institute

Department

Personal name



Funding Source

Organization

Tohoku University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Tohoku University Hospital Clinical Research Ethics Committee

Address

2-1 Seiryo-cho, Aoba-ku, Sendai, Miyagi

Tel

022-717-7145

Email

rinri-2@proj.med.tohoku.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

東北大学病院


Other administrative information

Date of disclosure of the study information

2016 Year 06 Month 07 Day


Related information

URL releasing protocol

https://upload.umin.ac.jp/cgi-bin/ctr/ctr_up_reg_f3.cgi

Publication of results

Unpublished


Result

URL related to results and publications

https://upload.umin.ac.jp/cgi-bin/ctr/ctr_up_reg_f5.cgi

Number of participants that the trial has enrolled

12

Results

rTMS caused less pain and discomfort than TES, but this was only evident when comparatively large joint movements occurred.

Results date posted

2020 Year 09 Month 28 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

The subjects were 12 healthy adults with no neurological abnormalities of the arms. The group was comprised of 7 men and 5 women with a mean age of 23.0. All subjects were right-handed according to the Edinburgh inventory of handedness.

Participant flow

Of all subjects, half of the subjects performed in the order of rPMS condition to TES condition. Another half of the subjects performed in the order of TES condition to rPMS condition.

Adverse events

None.

Outcome measures

Dorsiflexion angle of the wrist joint. Pain and discomfort using a numerical rating scale.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Suspended

Date of protocol fixation

2016 Year 05 Month 01 Day

Date of IRB

2017 Year 07 Month 07 Day

Anticipated trial start date

2017 Year 07 Month 07 Day

Last follow-up date

2018 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 06 Month 06 Day

Last modified on

2023 Year 08 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026085


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name