UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053028 |
|---|---|
| Receipt number | R000060492 |
| Scientific Title | Investigation of change in body cognition in restless legs syndrome |
| Date of disclosure of the study information | 2024/01/01 |
| Last modified on | 2023/12/07 10:51:20 |
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Basic information
Public title
Investigation of change in body cognition in restless legs syndrome
Acronym
Body cognition in restless legs syndrome
Scientific Title
Investigation of change in body cognition in restless legs syndrome
Scientific Title:Acronym
Body cognition in restless legs syndrome
Region
| Japan |
Condition
Condition
restless legs syndrome/ normal
Classification by specialty
| Neurology | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine body cognition in restless legs syndrome using the rubber hand illusion and the robot hand illusion.
Basic objectives2
Others
Basic objectives -Others
Basic study of neurophysiology
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Compare between groups the sense of body ownership and the sense of agency induced by the illusion.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 12 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient Group
･Patients who meet the diagnostic criteria for restless legs syndrome.
･After receiving a thorough explanation of the study, the patient or his/her parent/guardian (in the case of a minor) gave free and voluntary written consent.
･The patient has no difficulty in understanding the explanations given by the investigator.
Control (healthy) group
･Similar in age and sex to the patient group.
･No history of psychiatric or neurological disorders.
･The patients who have been fully informed about the study and have given their free written consent, or in the case of minors, their guardians have given their free written consent
･The patient has no difficulty in understanding the explanations given by the researcher.
Key exclusion criteria
Patient Groups
･Patients with secondary restless legs syndrome such as concomitant iron deficiency anemia.
･Other patients deemed inappropriate as research subjects by the investigators.
Control (normal) group
･Other psychiatric/neurological disorders for which the investigator determines that the subject is inappropriate.
･Other conditions deemed inappropriate by the investigator.
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Toshimitsu |
| Middle name | |
| Last name | Takahashi |
Organization
Dokkyo Medical University School of Medicine
Division name
Depertment of Physiology
Zip code
321-0293
Address
880 Kitakobayashi, Mibu, Shimotsuga, Tochigi
TEL
0282-87-2126
tositaka@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Toshimitsu |
| Middle name | |
| Last name | Takahashi |
Organization
Dokkyo Medical University School of Medicine
Division name
Depertment of Physiology
Zip code
321-0293
Address
880 Kitakobayashi, Mibu, Shimotsuga, Tochigi
TEL
0282-87-2126
Homepage URL
tositaka@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
Institutional Review Board for Clinical Research
Address
880 Kitakobayashi, Mibu, Shimotsuga, Tochigi
Tel
0282-87-2275
r-kenkyu@dokkyomed.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
| 2024 | Year | 01 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2034 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We examine body cognition in restless legs syndrome using rubber hand illusion and robot hand illusion.
Management information
Registered date
| 2023 | Year | 12 | Month | 07 | Day |
Last modified on
| 2023 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060492
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
