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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004872
Receipt No. 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

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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
Email 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
Email skoba-tky@umin.net

Sponsor
Institute Fukushima Medical University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005791

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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