UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019106 |
|---|---|
| Receipt number | R000022085 |
| Scientific Title | Effect of pairing peripheral and transcranial magnetic stimulations triggered by actual movement on motor plasticity |
| Date of disclosure of the study information | 2015/10/01 |
| Last modified on | 2020/03/30 13:31:04 |
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Basic information
Public title
Effect of pairing peripheral and transcranial magnetic stimulations triggered by actual movement on motor plasticity
Acronym
Effect of pairing peripheral and transcranial magnetic stimulations triggered by actual movement on motor plasticity
Scientific Title
Effect of pairing peripheral and transcranial magnetic stimulations triggered by actual movement on motor plasticity
Scientific Title:Acronym
Effect of pairing peripheral and transcranial magnetic stimulations triggered by actual movement on motor plasticity
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the safety and the efficacy of pairing peripheral and transcranial magnetic stimulations triggered by actual movement in healthy subjects and stroke patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Healthy subjects: Direction of transcranial magnetic stimulation-induced upper limb movement
Stroke patients: Direction of transcranial magnetic stimulation-induced upper limb movement of the paretic side
Key secondary outcomes
Healthy subjects: Excitability of cortico-spinal tract
Stroke patients: Excitability of cortico-spinal tract
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Subthreshold peripheral and transcranial magnetic stimulations with actual movement
Interventions/Control_2
Sham peripheral and transcranial magnetic stimulations with actual movement
Interventions/Control_3
Subthreshold peripheral and transcranial magnetic stimulations without actual movement
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy subjects: healthy adult volunteers.
Stroke patients: Chronic stroke patients (more than 3 months after the onset) who were inpatients and outpatients of Tohoku University Hospital.
Key exclusion criteria
Subjects with metal in cranium, trauma or operation of brain, intracardiac lines, increased intracranial pressure, pregnancy, childhood, heart disease, cardiac pacemaker, medication pump, tricyclic anti-depressants, neuroleptics, febrile convulsion, epilepsy, family history of epilepsy.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shin-Ichi |
| Middle name | |
| Last name | Izumi |
Organization
Tohoku University Graduate School of Biomedical Engineering
Division name
Department of Physical Medicine and Rehabilitation
Zip code
980-8575
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-7338
izumis@bme.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Akihiko |
| Middle name | |
| Last name | Asao |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Physical Medicine and Rehabilitation
Zip code
980-8575
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-7338
Homepage URL
a3omail@gmail.com
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research, Innovation and Education Center, Tohoku University Hospital
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
Tel
022-717-7122
office@crieto.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
| 2015 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000022085&ty
Publication of results
Unpublished
Result
URL related to results and publications
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000022085&ty
Number of participants that the trial has enrolled
1
Results
Induction movement elicited by Trancsranial magnetic stimulation after movement triggered paired magnetic simulations was greater than the one after actual movements.
Results date posted
| 2020 | Year | 03 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy subject
Participant flow
Public application
Adverse events
None
Outcome measures
Twitch movement and Motor evoked potential induced by Transcranial magnetic stimulation
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2016 | 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
| 2015 | Year | 09 | Month | 24 | Day |
Last modified on
| 2020 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022085
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
