UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051286 |
|---|---|
| Receipt number | R000058493 |
| Scientific Title | A study to investigate the mechanism of repetitive peripheral magnetic stimulation in the treatment of spasticity |
| Date of disclosure of the study information | 2023/06/08 |
| Last modified on | 2023/08/17 09:53:44 |
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Basic information
Public title
A study to investigate the mechanism of repetitive peripheral magnetic stimulation in the treatment of spasticity1
Acronym
Investigating the mechanism of treatment of spasticity in rPMS2
Scientific Title
A study to investigate the mechanism of repetitive peripheral magnetic stimulation in the treatment of spasticity
Scientific Title:Acronym
Investigating the mechanism of treatment of spasticity in rPMS
Region
| Japan |
Condition
Condition
central motor palsy
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the neurophysiological mechanisms in the treatment of spasticity with repetitive peripheral magnetic stimulation.
Basic objectives2
Others
Basic objectives -Others
This is a basic study, and its purpose is to investigate the mechanism of peripheral magnetic stimulation in the treatment of spasticity. It is not intended to evaluate the safety or efficacy of the equipment used in this study.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Phase I
Assessment
Primary outcomes
Evaluate repressive inhibition before, immediately after, 15 minutes after, and 30 minutes after stimulation with rPMS or NMES.
Key secondary outcomes
- Spasticity (modified Ashworth scale, modified Tardieu scale, foot clonus) (pre-stimulation, 30 minutes after stimulation)
- Physiological assessment (surface electromyography, motor evoked potentials) (pre-stimulation, immediately after stimulation, 15 minutes, 30 minutes after stimulation)
- Joint range of motion (pre-stimulation, 30 minutes after stimulation)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
peripheral magnetic stimulation
Interventions/Control_2
neuromuscular electrical stimulation
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Motor paralysis due to the unilateral lesion
General condition is stable
No evidence of cognitive decline or serious aphasia, and the patient is able to understand the study
Written consent based on the patient's free will has been obtained after a thorough explanation of the study
Key exclusion criteria
1) Those who have a cardiac pacemaker or artificial heart valve
2) Patients with an indwelling catheter in the heart
3) Patients with severe cardiac disease
4) Patients with obvious intracranial hypertension
5) Patients using a medical pump
6) Dependent on intra- or extracorporeal life support devices
7) Who have surgical clips or ferromagnetic materials in their body to stop bleeding
8) Who have a cochlear implant
9) Who may have metal fragments in their body
10) Persons with a history of convulsions or syncope
11) Persons with a history or family history of epilepsy
12) Persons with a history of suspected epilepsy or a family history of epilepsy
13) Persons with recent burns or skin lesions on the affected area
14) Patients with serious orthopedic complications that interfere with movement
15) Patients with a history of neuromuscular disease
16) Persons with other recent acute systemic illnesses or unstable general condition
17) Persons with severe dementia or complications of severe mental illness
18) Persons who may be pregnant
19) Other persons deemed inappropriate by the physician
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Michiyuki |
| Middle name | |
| Last name | Kawakami |
Organization
Keio University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
160-8582
Address
35, Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
michiyukikawakami@hotmail.com
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Kamimoto |
Organization
Keio University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
160-8582
Address
35, Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
Homepage URL
rw.mssl.720@gmail.com
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Watanabe Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Rehabilitation Medicine, Keio University School of Medicine
Address
35, Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-3353-1211
rw.mssl.720@gmail.com
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
慶應義塾大学病院
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 08 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 06 | Month | 06 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2023 | Year | 06 | Month | 07 | Day |
Last modified on
| 2023 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058493
