UMIN-ICDS Clinical Trial

Public title

Exploratory Study of Physiological Responses to Transvertebral Magnetic Stimulation

Acronym

TVMS Exploratory Study

Scientific Title

Exploratory Study on Physiological Responses and Stimulation Parameters of Transvertebral Magnetic Stimulation

Scientific Title:Acronym

TVMS Response and Parameter Study

Region

Japan

Condition

Healthy adults and patients with neurological disorders

Classification by specialty

Rehabilitation medicine

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The objective of this study is to exploratorily evaluate physiological responses, including motor, sensory, and autonomic responses, induced by transvertebral magnetic stimulation in healthy adults and patients with neurological disorders, and to investigate the relationship between stimulation parameters, such as stimulation site, intensity, direction, and frequency, and the elicited biological responses.

Basic objectives2

Others

Basic objectives -Others

To evaluate physiological responses induced by transvertebral magnetic stimulation and to exploratorily investigate the relationship between stimulation parameters and biological responses.

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

Physiological responses induced by transvertebral magnetic stimulation. Specifically, the presence or absence of evoked muscle activity, latency, amplitude, area, response threshold assessed by surface electromyography, and changes in neurophysiological measures before and after stimulation will be evaluated.

Key secondary outcomes

The relationships between stimulation parameters, including stimulation site, intensity, direction, and frequency, and physiological responses will be evaluated. Sensory responses, autonomic responses, motor function, changes in subjective symptoms, and the occurrence of adverse events will also be assessed.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Self control

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

Transvertebral magnetic stimulation will be performed as the main intervention, with transcutaneous electrical stimulation added when necessary. The participation period for each participant will be up to 30 weeks from the date of informed consent to the final assessment. Experimental sessions involving stimulation will be conducted up to 24 times per participant, generally no more than once per week. Each experimental session will last up to approximately 3 hours, including preparation, rest, and assessments before and after stimulation. In each session, transvertebral magnetic stimulation will be performed at rest and/or during voluntary motor tasks, and stimulation parameters such as intensity, frequency, stimulation site, and stimulation direction will be set exploratorily within a range that ensures participant safety. Transcutaneous electrical stimulation may be combined when necessary, and assessments such as electromyography, motion analysis, muscle strength assessment, sensory assessment, autonomic nervous system assessment, and transcranial magnetic stimulation-based evaluation will be performed.

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

Age-lower limit

18

years-old

<=

Age-upper limit

90

years-old

>

Gender

Male and Female

Key inclusion criteria

Participants who meet all of the following criteria will be included:

Individuals who have received a sufficient explanation of the study and have provided written informed consent
Individuals judged by the principal investigator or sub-investigator to be able to participate in the study
Individuals who can understand the study tasks and follow instructions to perform motor tasks
Individuals aged 18 years or older and younger than 90 years at the time of informed consent
For healthy participants, individuals with no apparent history of neurological or muscular disease and no difficulty in voluntary movement of the upper or lower limbs
For patients with neurological disorders, individuals with a history of neurological disorder, motor impairment of the upper or lower limbs, and a stable condition after the acute phase

Key exclusion criteria

Individuals who meet any of the following criteria will be excluded:

1.Individuals whose underlying disease is unstable
2.Women who are pregnant or may be pregnant
3.Women who are breastfeeding
4.Individuals who have experienced adverse effects caused by magnetic or electrical stimulation
5.Individuals with implanted medical devices such as a cardiac pacemaker, deep brain stimulator, or insulin pump
6.Individuals judged by the principal investigator or sub-investigator to be unsuitable for participation in the study for any other reason

Target sample size

100

Name of lead principal investigator

1st name	Hironori
Middle name
Last name	Tsuji

Organization

Okayama University Hospital

Division name

Department of Advanced Musculoskeletal Rehabilitation Medicine

Zip code

7008558

Address

2-5-1, Shikatacho, Kita-ku, Okayama, Japan

TEL

+81-86-235-7273

Email

tujiken0921@gmail.com

Name of contact person

1st name	Hironori
Middle name
Last name	Tsuji

Organization

Okayama University Hospital

Division name

Department of Advanced Musculoskeletal Rehabilitation Medicine Faculty of Medicine

Zip code

7008558

Address

2-5-1, Shikatacho, Kita-ku, Okayama, Japan

TEL

+81-86-235-7273

Homepage URL

Email

tujiken0921@gmail.com

Institute

Okayama University Hospital

Institute

Department

Personal name

Hironori Tsuji

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

The Watanabe Foundation

Organization

Okayama University Ethics Committee Office

Address

2-5-1 Shikata-cho, Kita-ku, Okayama, Okayama 700-8558, Japan

Tel

086-235-6938

Email

mae6605@adm.okayama-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

07

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

06

Month

28

Day

Date of IRB

Anticipated trial start date

2026

Year

08

Month

01

Day

Last follow-up date

2032

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

06

Month

27

Day

Last modified on

2026

Year

06

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070983