UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030523 |
|---|---|
| Receipt number | R000033092 |
| Scientific Title | Utility of transcranial direct current electrical stimulation for musculoskeletal / spinal cord disease |
| Date of disclosure of the study information | 2020/03/31 |
| Last modified on | 2017/12/22 14:29:17 |
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Basic information
Public title
Utility of transcranial direct current electrical stimulation for musculoskeletal
/ spinal cord disease
Acronym
Utility of transcranial direct current electrical stimulation
Scientific Title
Utility of transcranial direct current electrical stimulation for musculoskeletal
/ spinal cord disease
Scientific Title:Acronym
Utility of transcranial direct current electrical stimulation
Region
| Japan |
Condition
Condition
Cervical spondylotic myelopathy, Cervical spondylotic amyotrophy, Rotator cuff tear, and Frozen shoulder
Classification by specialty
| Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of effect of transcranial direct current stimulation for spinal cord and musculoskeletal diseases
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation
1) Sensory: VAS, PainVision
2) Motor function: strength, dexterity, ability of balance, locomotive ability
3) Corticospinal excitability
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
transcranial direct current stimulation
Interventions/Control_2
sham stimulation (control)
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
1) Have the capacity to give informed consent
2) Have a normal neurological exam
3) Aged over 20
4) Healthy volunteer or having one of the following diseases: Cervical spondylotic myelopathy, Cervical spondylotic amyotrophy, Rotator cuff tear, and Frozen shoulder
5) Right-hand dominant
6) Non of contraindication for TMS or tDCS
Key exclusion criteria
1. Having more than one of the following diseases: Cervical spondylotic myelopathy, cervical spondylotic amyotrophy, Rotator cuff tear, and frozen shoulder
2. Presence of resting pain
3. Pregnancy
4. Complete motor paralysis
5. Having contraindication for TMS or tDCS
6. Any finding on the MRI safety questionnaire that prevents them from safely undergoing an MRI scan
7. Inappropriate judged by a doctor for participation in the study
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hitoshi Shitara |
Organization
Gunma University Hospital
Division name
Orthopaedic surgery
Zip code
Address
3-39-22 Showa, Maebashi, Gunma
TEL
0272208269
hshitara@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hitoshi Shitara |
Organization
Gunma University Hospital
Division name
Orthopaedic surgery
Zip code
Address
3-39-22 Showa, Maebashi, Gunma
TEL
0272208269
Homepage URL
hshitara@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Hospital
Institute
Department
Personal name
Funding Source
Organization
JSPS Fujita Memorial Fund for Medical Research
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2020 | Year | 03 | Month | 31 | 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
| 2013 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 01 | 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
| 2017 | Year | 12 | Month | 22 | Day |
Last modified on
| 2017 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033092
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
