UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060037 |
|---|---|
| Receipt number | R000068652 |
| Scientific Title | Repetitive Peripheral Magnetic Stimulation (rPMS) for Post-Stroke Sequelae: A Prospective Interventional Study |
| Date of disclosure of the study information | 2025/12/10 |
| Last modified on | 2025/12/10 15:41:20 |
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Basic information
Public title
Repetitive Peripheral Magnetic Stimulation (rPMS) for Post-Stroke Sequelae: A Prospective Interventional Study
Acronym
rPMS for PSS
Scientific Title
Repetitive Peripheral Magnetic Stimulation (rPMS) for Post-Stroke Sequelae: A Prospective Interventional Study
Scientific Title:Acronym
rPMS-PSS
Region
| Japan |
Condition
Condition
Patients presenting with post-stroke sequelae such as dysphagia, gait disturbance, upper-limb dysfunction, and respiratory impairment.
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the therapeutic effects of repetitive peripheral magnetic stimulation (rPMS) to patients with post-stroke sequelae (e.g., dysphagia, gait disturbance, upper-limb dysfunction, and respiratory impairment)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(For upper limb function)
Fugl-Meyer Assessment for the Upper Extremity (FMA-UE)
Action Research Arm Test (ARAT)
Modified Ashworth Scale
Active range of motion (AROM)
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
rPMS combined with intensive rehabilitation program
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with post-stroke symptoms such as dysphagia, walking disorder, upper limb dysfunction, and respiratory dysfunction
Key exclusion criteria
Patients who are unable to fully understand the study content due to impaired comprehension or other reasons will be excluded from the study.
Patients with internal medical devices (such as pacemakers), internal metal objects (such as implants) near the magnetic stimulation site, patients with serious heart disease, or patients with venous thrombosis will be excluded from the study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shoji |
| Middle name | |
| Last name | Kinoshita |
Organization
Jikei University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
105-8461
Address
3-25-8, Nishi-Shimbashi, Minato-Ku, Tokyo
TEL
03-3433-1111
kinoshita@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Shoji |
| Middle name | |
| Last name | Kinoshita |
Organization
Jikei University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
105-8461
Address
3-25-8, Nishi-Shimbashi, Minato-Ku, Tokyo
TEL
03-3433-1111
Homepage URL
kinoshita@jikei.ac.jp
Sponsor or person
Institute
Jikei University School of Medicine
Institute
Department
Personal name
Shoji Kinoshita
Funding Source
Organization
N/A
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Koyama Rehabilitation Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Koyama Rehabilitation Hospital
Address
405-25, Obuchi, Fuji, Shizuoka
Tel
0545-36-2000
koyama-hp@momoha.or.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2024-8
Org. issuing International ID_1
Koyama Rehabilitation Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
湖山リハビリテーション病院
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 10 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2035 | 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
| 2025 | Year | 12 | Month | 10 | Day |
Last modified on
| 2025 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068652
