UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059412 |
|---|---|
| Receipt number | R000067949 |
| Scientific Title | Computational approaches to address spatial neglect |
| Date of disclosure of the study information | 2025/10/15 |
| Last modified on | 2025/10/15 10:07:45 |
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Basic information
Public title
Computational approaches to address spatial neglect
Acronym
USN Kinarm Study
Scientific Title
Computational approaches to address spatial neglect
Scientific Title:Acronym
USN Kinarm Study
Region
| Japan |
Condition
Condition
Healthy
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Conventional treatments for unilateral spatial neglect focus on attention, directing training, but such methods are limited when attention networks are damaged, making outcomes dependent on patients' abilities. This study explores a method to promote responses to the neglected space without engaging the attentional network.
Express visuomotor response (EVR; a rapid limb adjustment to sudden target shifts during reaching) occurs through a reflexive, subcortical pathway, likely involving the superior colliculus, and does not require attention. Therefore, EVR may help guide movements toward neglected space.
Additionally, presenting stimuli from the neglected (left) field into the attended (right) field, or using specific colors and illustrations processed via non-attentional visual pathways, may further enhance responses. This study tests whether combining EVR, visuospatial shifts, and visual features can effectively facilitate reactions toward the neglected space.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
Upper-limb kinematic parameters
Gaze
EEG
EMG
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
[Stroke Patients]
- Inpatients or outpatients with stroke.
- Individuals clinically reported to show symptoms of unilateral spatial neglect.
Key exclusion criteria
[Healthy participants]
- No history of neurological disorders.
- No visual problems such as diplopia (including visual field defects).
[Stroke patients]
- No history of neurological disorders other than stroke.
- Able to understand the experimental tasks.
- No visual problems such as diplopia (including visual field defects).
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Rieko |
| Middle name | |
| Last name | Osu |
Organization
Waseda University
Division name
Faculty of Human Sciences
Zip code
359-1165
Address
210, Frontier Research Center, 135-1, Horinouchi, Tokorozawa, Saitama
TEL
04-2947-7346
r.osu@waseda.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Ito |
Organization
Waseda University
Division name
Graduate School of Human Sciences
Zip code
359-1165
Address
210, Frontier Research Center, 135-1, Horinouchi, Tokorozawa, Saitama
TEL
04-2947-7346
Homepage URL
y.ito@moegi.waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Waseda University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Waseda University, Ethics Review Procedures concerning Research with Human Subjects
Address
1-104, Totsuka-chou, shinjuku-ku, Tokyo
Tel
03-5272-1639
rinri@list.waseda.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2024-128
Org. issuing International ID_1
Waseda University, Ethics Review Procedures concerning Research with Human Subjects
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Kinematic parameters of the upper limb, gaze, EEG, and EMG data will be recorded during the motor task.
Management information
Registered date
| 2025 | Year | 10 | Month | 15 | Day |
Last modified on
| 2025 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067949
