UMIN-ICDS Clinical Trial

Public title

Evaluating the efficacy of transcranial Static Magnetic Stimulation in the rehabilitation of hemiplegic stroke patients

Acronym

Evaluating the efficacy of tSMS in the rehabilitation of hemiplegic stroke patients

Scientific Title

Evaluating the efficacy of transcranial Static Magnetic Stimulation in the rehabilitation of hemiplegic stroke patients. a randomized, double-blind, crossover trial

Scientific Title:Acronym

Evaluating the efficacy of tSMS in the rehabilitation of hemiplegic stroke patients. a randomized, double-blind, crossover trial

Region

Japan

Condition

hemiplegic stroke patient

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Non-invasive brain stimulation (NIBS) has attracted attention in recent years. Transcranial static magnetic stimulation (tSMS) is a new NIBS that has been shown to suppress brain excitability by simply placing a powerful permanent magnet on the surface of the head. tSMS does not cause seizures or burns. tSMS does not cause seizures or burns and does not require special equipment because it uses only permanent magnets.
tSMS does not require special equipment and can be used in conjunction with rehabilitation during stimulation. However, it has not been determined whether tSMS promotes functional recovery of motor paralysis after stroke. Therefore, the purpose of this study was to evaluate the clinical efficacy of tSMS in improving the functional recovery of post-stroke motor paralysis.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I

Primary outcomes

The duration of the first and second interventions will be 10 days and will be evaluated using motor function tests of the upper limb extremity.

Key secondary outcomes

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

The intervention is a condition (tSMS combined therapy) in which a small neodymium magnet is set in the cephalic surface of the contralesional primary motor area (C3 or C4 region) for 20 minutes based on the International 10-20 system method during a 60-minute rehabilitation. Washout period is performed for 2 days, followed by placement of a stainless steel block in the same way (sham combined therapy).

Interventions/Control_2

After the sham combined therapy, a washout period of 2 days is allowed and the tSMS combined therapy is administered.

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

Patients with a first unilateral stroke between 30 and 90 days after onset, with Brunnstrom recovery level 3-5 of the paralyzed side of the hand (sufficient active flexion of the hand).

Key exclusion criteria

The patient has significant cognitive decline or higher brain dysfunction, active systemic or psychiatric disease, or intracranial metal, pacemaker, cervical spine, or other conditions that the treating physician determines to be of clinical or safety concern.

Target sample size

30

Name of lead principal investigator

1st name	Yoshihiro
Middle name
Last name	Yukawa

Organization

Department of Rehabilitation, Wakayama Professional University of Rehabilitation,

Division name

Faculty of Health Sciences, DepartmentDepartment of Rehabilitation

Zip code

640- 8222

Address

3-1 Minato-Honcho, Wakayama City, Wakayama Prefecture

TEL

073-435-4888

Email

yukawa@kyowa.ac.jp

Name of contact person

1st name	Yoshihiro
Middle name
Last name	Yukawa

Organization

Department of Rehabilitation, Wakayama Professional University of Rehabilitation,

Division name

Faculty of Health Sciences, Department of Rehabilitation

Zip code

640- 8222

Address

3-1 Minato-Honcho, Wakayama City, Wakayama Prefecture

TEL

073-435-4888

Homepage URL

Email

yukawa@kyowa.ac.jp

Institute

Department of Rehabilitation, Wakayama Professional University of Rehabilitation,

Institute

Department

Personal name

Organization

Japan Science and Technology Agency

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

N/A

Address

N/A

Tel

N/A

Email

N/A

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

2023

Year

07

Month

27

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

Enrolling by invitation

Date of protocol fixation

2019

Year

04

Month

01

Day

Date of IRB

2022

Year

03

Month

06

Day

Anticipated trial start date

2022

Year

03

Month

10

Day

Last follow-up date

2025

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2023

Year

07

Month

27

Day

Last modified on

2023

Year

07

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058958