UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000005791