UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038714 |
|---|---|
| Receipt number | R000044080 |
| Scientific Title | Human somatosensory localization - Comparison between healthy subjects and patients with superficial sensory disorders |
| Date of disclosure of the study information | 2019/12/05 |
| Last modified on | 2021/02/17 11:35:10 |
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Basic information
Public title
Human somatosensory localization - Comparison between healthy subjects and patients with superficial sensory disorders
Acronym
Human somatosensory localization
Scientific Title
Human somatosensory localization - Comparison between healthy subjects and patients with superficial sensory disorders
Scientific Title:Acronym
Human somatosensory localization
Region
| Japan |
Condition
Condition
Dabetes mellitus
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarfication of human somatosensory localization
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
accuracy in somatosensory licalization task
Key secondary outcomes
1.Reaction time in somatosensory licalization task
2.pain sensation induced by Transcranial magnetic stimulation (TMS)
3.Motor-evoked potential induced by TMS
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
somatosensory localization task
Interventions/Control_2
Transcranial magnetic stimulation
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients
1. Aged between 20 and 80 years old
2. Individuals who have been diagnosised as patients with peripheral neuropathy derived from diabetes mellitus
3. Individuals who have mild or moderate superficial sensory disorders in their toes
4. Capability of informed consent based on their own decision
Healthy subjects
1. Aged between 20 and 80 years old
2. Capability of informed consent based on their own decision
Key exclusion criteria
1. Individuals with a history of head trauma
2. Individuals with a history of organic brain or spinal cord disease
3. Individuals with heavy superficial sensory disorders
4. Individuals with heavy pain sensation and nubness in their foots or toes
5. Individuals with motor dysfunction in their fingers
6. Individuals with a history or current history of drug dependence
7. Individuals who have a history of disorders of consciousness and/or seizure
8. Individuals who have a chronic headache
9. Individuals who are unable to undergo MRI
10. Individuals who are unable to undergo TMS
11. Individuals that researchers decide that they are inappropriate for study participation
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Tani |
Organization
Hamamatsu University School of Medicine
Division name
psychology
Zip code
4313192
Address
1-20-1 Handayama Higashi-ku, Hamamatsu-city, Japan
TEL
0534532387
k.tani@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Tani |
Organization
Hamamatsu University School of Medicine
Division name
psychology
Zip code
4313192
Address
1-20-1 Handayama Higashi-ku, Hamamatsu-city, Japan
TEL
0534532387
Homepage URL
k.tani@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu
Tel
0534532387
tanakas@hama-med.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
| 2019 | Year | 12 | Month | 05 | 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
| 2019 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 05 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 11 | Month | 28 | Day |
Last modified on
| 2021 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044080
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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