UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042701 |
|---|---|
| Receipt number | R000048732 |
| Scientific Title | Prism adaptation changes resting-state functional connectivity in unilateral spatial neglect patients. |
| Date of disclosure of the study information | 2020/12/09 |
| Last modified on | 2022/06/11 16:08:12 |
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Basic information
Public title
Prism adaptation changes resting-state functional connectivity in unilateral spatial neglect patients.
Acronym
Prism adaptation changes resting-state functional connectivity in unilateral spatial neglect patients.
Scientific Title
Prism adaptation changes resting-state functional connectivity in unilateral spatial neglect patients.
Scientific Title:Acronym
Prism adaptation changes resting-state functional connectivity in unilateral spatial neglect patients.
Region
| Japan |
Condition
Condition
Unilateral spatial neglect patients
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study investigated the changes in resting-state FC induced by PA session in unilateral spatial neglect patients as a first step to elucidate the underlying mechanism of the therapeutic effects of PA therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
resting-state functional connectivity in attention network
Key secondary outcomes
reaction time of the visual attention task
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Unilateral spatial neglect patients
2)age 20-80/ male and female
3) Those who have consented to the study
Key exclusion criteria
1) Those who have metal in the head and neck
2) Those who use a pacemaker
3) Persons with severe cognitive impairment and severe mental illness
4) Persons judged inappropriate by a doctor for other reasons
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Katsuhiro |
| Middle name | |
| Last name | Mizuno |
Organization
National Center Hospital
National Center of Neurology and Psychiatry
Division name
Department of Physical Rehabilitation
Zip code
187-8551
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo
TEL
042-341-2711
mizuno.katsuhiro@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Kengo |
| Middle name | |
| Last name | Tsujimoto |
Organization
National Center Hospital National Center of Neurology and Psychiatry
Division name
Department of Physical Rehabilitation
Zip code
187-8551
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo
TEL
042-341-2711
Homepage URL
tsujimoto_k@ncnp.go.jp
Sponsor or person
Institute
National Center Hospital National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
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
National Center Hospital National Center of Neurology and Psychiatry
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo
Tel
042-341-2711
tsujimoto_k@ncnp.go.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
| 2020 | Year | 12 | Month | 09 | 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
| Delay expected |
Results Delay Reason
Delays due to lack of patient recruitment.
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
| 2020 | Year | 11 | Month | 11 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 11 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 11 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing
Management information
Registered date
| 2020 | Year | 12 | Month | 09 | Day |
Last modified on
| 2022 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048732
