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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000038714
Receipt No. 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 2020/03/05

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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
Email 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
Email k.tani@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

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
Email 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
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
2020 Year 03 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044080

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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