UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028079 |
|---|---|
| Receipt number | R000032144 |
| Scientific Title | Effect of sensory input to voluntary movement in patients with central movement disorders. |
| Date of disclosure of the study information | 2017/07/06 |
| Last modified on | 2022/07/09 09:22:19 |
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Basic information
Public title
Effect of sensory input to voluntary movement in patients with central movement disorders.
Acronym
Effect of sensory input to voluntary movement in patients with central movement disorders.
Scientific Title
Effect of sensory input to voluntary movement in patients with central movement disorders.
Scientific Title:Acronym
Effect of sensory input to voluntary movement in patients with central movement disorders.
Region
| Japan |
Condition
Condition
Parkinson's disease, Spasticity
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate effect of peripheral pain stimuli to motor control in patients with central movement disorders.
Basic objectives2
Others
Basic objectives -Others
To investigate effect of selective pain nerve fiber stimulation to spinal motor control mechanisms.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The extent of conditioning effect to H-reflex
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
peripheral nerve stimulation
transcranial magnetic stimulation
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 Parkinson's disease or spasticity, or normal healthy adults.
Key exclusion criteria
Patients as having other neurological disorders including dementia.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Morita |
Organization
Shinshu University
Division name
Center for Health, Safety and Environmental Management
Zip code
3908621
Address
Asahi 3-1-1 Matsumoto
TEL
0263372156
hmorita@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Morita |
Organization
Shinshu University
Division name
Center for Health, Safety and Environmental Management
Zip code
3908621
Address
Asahi 3-1-1 Matsumoto
TEL
0263372156
Homepage URL
hmorita@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Shinshu University
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical comittee Shinshu University Department of Medicie
Address
Asahi 3-1-1 Matsumoto
Tel
0263-37-2572
mdrinri@shinshu-u.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
| 2017 | Year | 07 | 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
20
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
| 2017 | Year | 07 | Month | 03 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 04 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 04 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 06 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 05 | Day |
Last modified on
| 2022 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032144
