UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044802
Receipt number R000051166
Scientific Title Distinct Neural Pathways of I-wave Facilitation Induced by TMS: Perspectives from Interhemispheric Interaction
Date of disclosure of the study information 2021/07/09
Last modified on 2023/07/10 19:05:04

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Basic information

Public title

Modulation of Interhemispheric Interaction by I-wave Periodicity Repetitive TMS

Acronym

I-wave Study

Scientific Title

Distinct Neural Pathways of I-wave Facilitation Induced by TMS: Perspectives from Interhemispheric Interaction

Scientific Title:Acronym

I-wave-IHF Study

Region

Japan


Condition

Condition

Adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine and compare the chronological effects on interhemispheric interaction of I1 and I3 facilitation via iTMS.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The amplitude of MEP evoked by single-pulse and paired-pulse TMS at 4 timepoints of the experiment: Pre-iTMS, Half-iTMS, Post-iTMS and 10min-Later-iTMS.

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

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Device,equipment

Interventions/Control_1

I-wave Periodicity Repetitive Transcranial Magnetic 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

65 years-old >=

Gender

Male and Female

Key inclusion criteria

Healthy right-handed adults (aged between 20-65 years old) with no history or current signs of neurological or musculoskeletal impairment, with no risk or contraindications regarding to the rTMS Screening Questionnaire.

Key exclusion criteria

Those who use medical electrical equipment (biological implantable medical electrical equipment such as pacemakers, life-supporting medical electrical equipment such as artificial heart-lung machine, wearable medical electrical equipment such as electrocardiograms);
Those who are pregnant or immediately after childbirth;
Those with infectious diseases;
Those with acute (painful) illness;
Those with hypothermia;
Those with blood circulation disorders;
Those with orthopedic disorders in the upper limbs;
Those who have had surgery on the upper limbs in the past;
Those with visual impairment including difficult-to-correct vision loss, narrowing of the visual field, and color vision deficiency;
Those with a history of central neurological or psychiatric disorders such as stroke, head injury, dementia, motor developmental retardation, and schizophrenia;
Those with motor and sensory disorders of the upper limbs;
Those who have subjective symptoms such as extreme optical illusion and decreased visual acuity due to eye strain.

Target sample size

15


Research contact person

Name of lead principal investigator

1st name Shin-Ichi
Middle name
Last name IZUMI

Organization

Tohoku University Graduate School of Medicine

Division name

Department of Physical Medicine & Rehabilitation

Zip code

980-8575

Address

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

TEL

022-717-7338

Email

reha@med.tohoku.ac.jp


Public contact

Name of contact person

1st name Dongting
Middle name
Last name Tian

Organization

Tohoku University Graduate School of Medicine

Division name

Department of Physical Medicine & Rehabilitation

Zip code

980-8575

Address

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

TEL

022-717-7338

Homepage URL


Email

reha@med.tohoku.ac.jp


Sponsor or person

Institute

TOHOKU University

Institute

Department

Personal name



Funding Source

Organization

TOHOKU 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

Ethics Committee Tohoku University Hospital

Address

1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi

Tel

022-728-4105

Email

ec@rinri.hosp.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



Other administrative information

Date of disclosure of the study information

2021 Year 07 Month 09 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

20

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

Completed

Date of protocol fixation

2021 Year 07 Month 08 Day

Date of IRB

2021 Year 12 Month 15 Day

Anticipated trial start date

2021 Year 12 Month 15 Day

Last follow-up date

2025 Year 12 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

2021 Year 07 Month 08 Day

Last modified on

2023 Year 07 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051166


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name