UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004872 |
|---|---|
| Receipt number | R000005791 |
| Scientific Title | Treatments of hemispatial neglect with CNS modulators |
| Date of disclosure of the study information | 2011/04/01 |
| Last modified on | 2019/07/21 10:47:31 |
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Basic information
Public title
Treatments of hemispatial neglect with CNS modulators
Acronym
treatment of hemispatial neglect
Scientific Title
Treatments of hemispatial neglect with CNS modulators
Scientific Title:Acronym
treatment of hemispatial neglect
Region
| Japan |
Condition
Condition
hemispatial neglect due to cerebrovascular accidents
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Hemispatial neglect (HSN) is a devastating cognitive dysfunction mainly caused by cerebrovascular accidents and its pathogenesis is still not well understood. Diagnosis of HSN is usually made based on figure copying and line bisection tests, which are not standardized. Several kinds of treatments, including extracranial magnetic stimulation and prism adaptation, remain explanatory. The present study aims to establish a quantifiable and standardized diagnostic method by using a computer-based visual detection task, and evaluate the effect of donepezil, widely used to treat Alzheimer disease, on the hemispatial neglect.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
Behavioral performance on a PC-based visual detection task
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
HSN. 1st. donepezil, 2nd placebo
Interventions/Control_2
HSN. 1st placebo, 2nd donepezil
Interventions/Control_3
healthy control. 1st. donepezil, 2nd placebo
Interventions/Control_4
healthy control. 1st placebo, 2nd donepezil
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 of hemispatial neglect at least 1 month after the onset of cerebrovascular accident. Age-matched healthy volunteer
Key exclusion criteria
Those who present apparent aphasia or dementia. Patients with history of epilepsy.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshikazu Ugawa |
Organization
Fukushima Medical University
Division name
Department of Neurology
Zip code
Address
1 Hikarigaoka , Fukushima-shi, Fukushima-ken
TEL
024-547-1248
ugawa-tky@umin.net
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shunsuke Kobayashi |
Organization
Fukushima Medical University
Division name
Department of Neurology
Zip code
Address
1 Hikarigaoka , Fukushima-shi, Fukushima-ken
TEL
024-547-1248
Homepage URL
skoba-tky@umin.net
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
JSPS
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
福島県立医科大学 (福島県)
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 04 | 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
Completed
Date of protocol fixation
| 2010 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2012 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2012 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2019 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2020 | Year | 08 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 01 | Month | 13 | Day |
Last modified on
| 2019 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005791
