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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030523
Receipt No. 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

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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
Email 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
Email hshitara@gunma-u.ac.jp

Sponsor
Institute Gunma University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.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


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