UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033763 |
|---|---|
| Receipt number | R000038402 |
| Scientific Title | Development of simple support tool for the diagnosis of frontotemporal lobar degeneration by speech analysis using artificial intelligence |
| Date of disclosure of the study information | 2018/10/01 |
| Last modified on | 2018/08/15 17:22:17 |
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Basic information
Public title
Development of simple support tool for the diagnosis of frontotemporal lobar degeneration by speech analysis using artificial intelligence
Acronym
Development of simple support tool for the diagnosis of frontotemporal lobar degeneration
Scientific Title
Development of simple support tool for the diagnosis of frontotemporal lobar degeneration by speech analysis using artificial intelligence
Scientific Title:Acronym
Development of simple support tool for the diagnosis of frontotemporal lobar degeneration
Region
| Japan |
Condition
Condition
FTLD
ALS
AD
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development of simple support tool for the diagnosis of frontotemporal lobar degeneration by speech analysis using artificial intelligence
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Sensitivity and specificity for diagnosis of FTLD
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
We will focus on cases clinically diagnosed as FTLD (bvFTD, SD, PNFA) and amyotrophic lateral sclerosis (ALS)
For comparison with FTLD, we will focus on AD patients and healthy control subjects.
Key exclusion criteria
We exclude cases that do not meet the diagnostic criteria.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Watanabe Hirohisa |
Organization
Nagoya University
Division name
Brain and Mind Research Center
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-1975
bmrc@adm.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kato Toshiyasu |
Organization
Nagoya University
Division name
Department of Neurology
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-741-2111
Homepage URL
kato.toshiyasu@g.mbox.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Department of Neurology
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 10 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 08 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
By recording and evaluating the sound of the patients with FTD and its related diseases, we will develop an evaluation tool that is useful for the early diagnosis of FTD.
Management information
Registered date
| 2018 | Year | 08 | Month | 15 | Day |
Last modified on
| 2018 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038402
