UMIN-CTR Clinical Trial

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
Email	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
Email	tsujimoto_k@ncnp.go.jp

Sponsor
Institute	National Center Hospital National Center of Neurology and Psychiatry
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000048732