UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017433 |
|---|---|
| Receipt number | R000020215 |
| Scientific Title | Facilitation of motor imagery using transcranial direct current stimulation |
| Date of disclosure of the study information | 2015/05/06 |
| Last modified on | 2015/05/06 17:30:18 |
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Basic information
Public title
Facilitation of motor imagery using transcranial direct current stimulation
Acronym
Facilitation of motor imagery
Scientific Title
Facilitation of motor imagery using transcranial direct current stimulation
Scientific Title:Acronym
Facilitation of motor imagery
Region
| Japan |
Condition
Condition
Patients with lower limb amputation
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the SMR of foot MI in healthy
subjects and in patients with lower limb amputations. We investigate whether tDCS could modulate the SMR of foot MI.
Basic objectives2
Others
Basic objectives -Others
physiological evaluation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
sensorimotor rhythm
Key secondary outcomes
Base
Study type
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Anodal transcranial direct current stimulation
Interventions/Control_2
Cathodal transcranial direct current stimulation
Interventions/Control_3
Sham stimulation
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) unilateralamputation above the ankle (2) more than 2 months duration after
amputation
(3) no or mild phantom limb pain
Key exclusion criteria
(1) seizure
(2) intracranial metallic implant or pacemakers
(3) intake of a drug that could modify
brain excitability
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoyuki Takeuchi |
Organization
Tohoku University
Division name
Rehabilitation
Zip code
Address
2-1 Seiryo-cho, Aoba-ku, Sendai
TEL
022-717-7338
naoyuki@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoyuki Takeuchi |
Organization
Tohoku University
Division name
Rehabilitation
Zip code
Address
2-1 Seiryo-cho, Aoba-ku, Sendai
TEL
022-717-7338
Homepage URL
naoyuki@med.hokudai.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
MEXT
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 05 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2012 | Year | 05 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 08 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 06 | Day |
Last modified on
| 2015 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020215
