UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049210 |
|---|---|
| Receipt number | R000056051 |
| Scientific Title | The Effects of Dual Task Interference Effects and Neural Basis in Drawing Tasks and the Paced Auditory Serial Addition Test. |
| Date of disclosure of the study information | 2022/10/13 |
| Last modified on | 2024/10/05 16:45:34 |
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Basic information
Public title
The Effects of Dual Task Interference Effects and Neural Basis in Drawing Tasks and the Paced Auditory Serial Addition Test.
Acronym
The Effects of Dual Task Interference Effects and Neural Basis in Drawing Tasks and the Paced Auditory Serial Addition Test.
Scientific Title
The Effects of Dual Task Interference Effects and Neural Basis in Drawing Tasks and the Paced Auditory Serial Addition Test.
Scientific Title:Acronym
The Effects of Dual Task Interference Effects and Neural Basis .
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate interference effects, brain activity and neural networks during a dual task of simultaneous motor and cognitive tasks
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Motor task: average velocity of spirals drawn against a model spiral, deviation distance (accuracy)
Cognitive task: Percent correct on PASAT
Brain activity: brain activity measured by fNIRS
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
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Right-handed healthy adult
Key exclusion criteria
No history or current history of psychiatric or neurological disorders
Persons who have given their consent in writing.
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Sawamura |
Organization
Faculty of Health Sciences, Hokkaido University
Division name
Rehabilitation Science
Zip code
060-0812
Address
Kita12-jo nishi5-chome Kita-ku Sapporo, Hokkaido, Japan
TEL
011-706-3387
D.sawamura@pop.med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Sawamura |
Organization
Faculty of Health Sciences, Hokkaido University
Division name
Rehabilitation Science
Zip code
060-0812
Address
Kita12-jo nishi5-chome Kita-ku Sapporo, Hokkaido, Japan
TEL
011-706-3387
Homepage URL
D.sawamura@pop.med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Hokkaido 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
Ethical review board of Faculty of Health Sciences, Hokkaido University
Address
Kita12-jo nishi5-chome Kita-ku Sapporo, Hokkaido, Japan
Tel
011-706-3316
Shomu@hs.hokudai.ac.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
北海道医療大学
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 13 | Day |
Related information
URL releasing protocol
https://pdf.sciencedirectassets.com/272508/1-s2.0-S1053811924X00117/1-s2.0-S1053811924002088/main.pd
Publication of results
Published
Result
URL related to results and publications
https://pdf.sciencedirectassets.com/272508/1-s2.0-S1053811924X00117/1-s2.0-S1053811924002088/main.pd
Number of participants that the trial has enrolled
34
Results
Significant decreases in task performance during two DT conditions were shown in BIS and PASAT. The right the dorsolateral prefrontal cortex (DLPFC) activity increases specifically during the dual task. Regarding the neural network analysis, there is an increase in the top-down direction from right DLPFC to IPC only in the DT PASAT 2-sec condition.
Results date posted
| 2024 | Year | 10 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The subjects were 34 right-handed normal persons between the ages of 18 and 30, and the sample size was calculated using G Power 3.1 based on previous studies. Written informed consent was obtained from all participants, and all experiments were conducted after approval from the Ethics Committee of the Faculty of Health Sciences at Hokkaido University.
Participant flow
The recruitment was conducted by posting posters on bulletin boards on the Hokkaido University campus and distributing flyers at Higashi Naebo Hospital and other locations.
Adverse events
None.
Outcome measures
The spiral drawing task was measured using a specific tablet, and the balanced integration score (BIS), considering the trade-off relationship between the speed and deviation distance, was calculated. PASAT-1s and 2s were recruited as cognitive tasks. This study constructed five conditions: Three single tasks (drawing, PASAT-2s, PASAT-1s) and two DTs (drawing+PASAT-2s, drawing+PASAT-1s). Functional Near-Infrared Spectroscopy (fNIRS, 38 channels) was used to measure brain activity in the bilateral frontal and parietal regions during tasks. Also, Multivariate Granger Causality Analysis (GCA) was applied to these areas to analyze the neural network. For statistical analysis, repeated measures ANOVA was performed on the behavioral and fNIRS data, A significance level of less than 0.05 was applied. And the Bonferroni method was used for both multiple comparison corrections.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 10 | Month | 13 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 26 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 18 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Subjects will be recruited using bulletin boards on the campuses of Hokkaido University and Hokkaido University of Health Sciences, and by posting and distributing flyers.
Methods: The cognitive tasks used were the PASAT 1-second condition (PASAT-1s) and the PASAT 2-second condition (PASAT-2s). The PASAT is an auditory working memory task in which participants are asked to add a single digit to a sequence of spoken digits presented every unit of time, and the correct response rate per execution is calculated. The motor task is a spiral drawing task using a tablet with the non-dominant hand, which is traced with a stylus so as not to deviate from the model spiral presented on the screen. During the exercise, the next spiral is presented in succession immediately after the target spiral is finished, and the average speed and deviation distance from the model spiral are measured during each execution. The results of the drawing task are converted to a combined measure of average speed and accuracy and compared. The ST condition consists of 1) drawing task, 2) PASAT-1s, and 3) PASAT-2s, and the DT condition consists of 4) drawing task + PASAT-1s and 5) drawing task + PASAT-2s. Each execution will last for 1 minute, and each condition will be performed 3 times each (total 22 minutes including breaks for all 15 blocks of tasks). The order of execution will be counterbalanced in consideration of the learning effect.
Management information
Registered date
| 2022 | Year | 10 | Month | 13 | Day |
Last modified on
| 2024 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056051
