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Name
UMIN ID

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000048543
Receipt No. R000055311
Scientific Title Development of an artificial intelligence-based primary headache diagnosis model
Date of disclosure of the study information 2022/08/01
Last modified on 2022/08/01

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Basic information
Public title Development of an artificial intelligence-based primary headache diagnosis model
Acronym Artificial intelligence-based primary headache diagnosis model
Scientific Title Development of an artificial intelligence-based primary headache diagnosis model
Scientific Title:Acronym Artificial intelligence-based primary headache diagnosis model
Region
Japan

Condition
Condition Headache
Classification by specialty
Medicine in general Neurology Pediatrics
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Few physicians can make a proper headache diagnosis from a medical interview and provide appropriate treatment according to the diagnosis. One reason for this is that the headache diagnosis is not always accurate. Therefore, it is hoped that clinicians can accurately diagnose headaches and lead to treatment without overlooking migraines, which have burdens on daily life. This study will develop an artificial intelligence (AI)-based diagnostic model that can accurately diagnose migraine from questionnaires by using a data set of approximately 4,000 outpatient headache cases at Tominaga Hospital. The development of this model will enable general practitioners who are not skilled in headache treatment to accurately diagnose migraine using this model and provide a bridge to appropriate headache treatment. To investigate the AI-based model's usefulness, the accuracy of the headache diagnosis made from the clinical questionnaire sheet by non-headache specialists will be investigated.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Diagnostic accuracy of headache diagnostic based on headache questionnaires by non-headache specialists with and without AI-based diagnostic models.
Key secondary outcomes Diagnostic accuracy of AI-based diagnostic models in the test data.

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria First-time patients who visited Tominaga Hospital Headache Outpatient Clinic
Key exclusion criteria Patients who cannot answer the questionnaire sheet
Target sample size 4000

Research contact person
Name of lead principal investigator
1st name Takao
Middle name
Last name Takeshima
Organization Tominaga Hospital
Division name Headache Center and Department of Neurology
Zip code 556-0017
Address 1 - 4 - 48 Minatomachi, Naniwa ward, Osaka, Japan
TEL 06-6568-1601
Email Takao.Takeshima@nifty.com

Public contact
Name of contact person
1st name Tomokazu
Middle name
Last name Shimazu
Organization Saitama Neuropsychiatric Institute
Division name Department of Neurology
Zip code 338-0003
Address 6-11-1 Honmachi-Higashi, Chuo-ku, Saitama, Saitama
TEL 048-857-6811
Homepage URL
Email tsyshimazu@aol.com

Sponsor
Institute Tominaga Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tominaga Hospital Research Ethics Committee
Address 1 - 4 - 48 Minatomachi, Naniwa ward, Osaka, Japan
Tel 06-6568-1601
Email Takao.Takeshima@nifty.com

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
2022 Year 08 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 4050
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 No longer recruiting
Date of protocol fixation
2022 Year 04 Month 05 Day
Date of IRB
2022 Year 04 Month 05 Day
Anticipated trial start date
2022 Year 04 Month 05 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Developing AI-diagnosing models.

Management information
Registered date
2022 Year 08 Month 01 Day
Last modified on
2022 Year 08 Month 01 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055311

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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