UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061818 |
|---|---|
| Receipt number | R000069754 |
| Scientific Title | Improvement of Upper Limb Motor Function After Stroke Using SMA-tDCS |
| Date of disclosure of the study information | 2026/06/06 |
| Last modified on | 2026/06/06 14:45:38 |
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Basic information
Public title
Improvement of Upper Limb Motor Function After Stroke Using SMA-tDCS
Acronym
Improvement of Post-Stroke Motor Impairment Through Non-Invasive Brain Stimulation
Scientific Title
Improvement of Upper Limb Motor Function After Stroke Using SMA-tDCS
Scientific Title:Acronym
Improvement of Post-Stroke Motor Impairment Through Non-Invasive Brain Stimulation
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effects of applying anode-to-cathode transcranial direct current stimulation (tDCS) to the supplementary motor area (SMA) during fine motor training in stroke patients, with the aim of examining the suppression of mirror activity and improvements in fine motor function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Motor evoked potential, Pegboard test, Purdue Pegboard Test, fugl-meyer assessment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
n-of-1
Randomization
Non-randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Upper Limb Motor Function Training for 1 week; Upper Limb Motor Function Training and SMA-tDCS for 1 week
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with upper limb motor impairment after stroke
Key exclusion criteria
metallic implants (e.g., cochlear implants or cardiac pacemakers) or a history of epilepsy or seizures were excluded.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Akihiro |
| Middle name | |
| Last name | Matsuura |
Organization
Hiroshima International University
Division name
Department of Rehabilitation
Zip code
7392695
Address
555-36 Kurose-gakuendai, Higashi-hiroshima, Hiroshima
TEL
0823704914
matsuura@hirokoku-u.ac.jp
Public contact
Name of contact person
| 1st name | Akihiro |
| Middle name | |
| Last name | Matsuura |
Organization
Hiroshima International University
Division name
Department of Rehabilitation
Zip code
7392695
Address
555-36 Kurose-gakuendai, Higashi-hiroshima, Hiroshima
TEL
0823704914
Homepage URL
matsuura@hirokoku-u.ac.jp
Sponsor or person
Institute
Inokuchi Hospital
Institute
Department
Personal name
Funding Source
Organization
Inokuchi Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Inokuchi Hospital Ethics Committee
Address
6-1 Saijyo-doyomaru, Higashihiroshima, Hiroshima
Tel
082-422-3711
hmana129@outlook.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
| 2026 | Year | 06 | Month | 06 | 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 | 04 | Month | 29 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 11 | Day |
Last follow-up date
| 2027 | 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
| 2026 | Year | 06 | Month | 06 | Day |
Last modified on
| 2026 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069754
