- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05377437
Natural Language Processing for Headache Medicine
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Headache disorders are among the most prevalent and disabling conditions worldwide . The Global Burden of Disease study 2016 found migraine to be the second most leading cause of disability worldwide. In the group of 18- to 49-year-olds, migraine is the leading cause of disability . Still, many patients do not receive adequate diagnosis or proper headache-specific treatments.
Physicians performing headache medicine need to have an accurate and complete headache history to construct a correct diagnosis and therapeutic plan. The diagnosis ideally needs to made by applying the International Classification of Headache Disorders Third Edition (ICHD-3). This process is essential to make the correct diagnosis within a reasonable amount of time. However, history taking in headache patients faces many challenges. It heavily relies on oral or written communication between them and patients. It is an effortful and time-consuming practice mostly for non-experienced physicians. Misinterpretation by patients or physicians within dialogue may occur and lead to misunderstandings, wrong diagnosis and maltreatment. Often, patients find difficulties to express all characteristics during a single visit to the doctor, leaving a wealth of useful information for the physician unused. Finally, measuring the burden of disease in headache disorders is difficult and mostly done through validated but rigid questionnaires. It may neglect the often complex but natural impact headache disorders have on all dimensions of human lives.
With the notable exception of e-diaries, digital tools for the headache physician are currently not available. Digital technology may offer many solutions to the challenges stated above. Globally, digitization is expanding faster than before. In the developed world, almost every person now has access to digital tools such as computers, smartphones or tablets. More than 3,5 billion people around the world were estimated to have access to the Internet in 2015 . Artificial intelligence (AI) and machine learning (ML) are entering our digital world rapidly, with already multiple use-cases being implemented in medicine. Algorithms in the field of imaging analysis, speech analysis and electronic patient database mining have been explored already to determine which beneficial effects can be derived from these techniques.
With increased computational speed, storage capacity and evolving user interfaces, new digital clinical applications have potential for helping the patient and physician along the trajectory of dealing with headache disorders. One such field within digital sciences is natural language processing (NLP). It uses text as input to generate mathematical models that have the potential to accurately classify and estimate numeric accounts on the basis of grammar, lexical content, sentimental value of words and word embeddings in sentences.
The investigators believe that the correct application of NLP in headache medicine can ultimately improve lives of many headache sufferers by giving correct diagnosis timely and facilitating communication about the burden of disease between patient and physician. This research project aims to develop NLP tools which are able to analyse patient-produced text about their headache problems to accurately diagnose headache disorders and to estimate the impact of headache disorders on patient's lives.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ghent, Belgium, 9000
- University Hospital Ghent
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Belgie
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Ghent, Belgie, Belgium, 9000
- Ghent University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients visiting the headache clinic of Ghent University Hospital for the first time or in follow up.
- Patients older than 18 years of age.
- Patients should be able to have Dutch as their mother tongue, and be sufficiently able to read, write, understand and speak Dutch.
Exclusion Criteria:
- Patients younger than 18 years of age.
- Patients with a language other than Dutch as mother tongue.
- Patients with substance abuse of alcohol or illicit drugs in the present or past.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Participants
Participants of the study
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Natural Language Processing: classification and regression tasks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
F1-scores classification migraine narrative versus cluster headache narrative
Time Frame: Baseline
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Machine learning classification models applying logistic regression, naive bayes classification and support vector machines based on the textual elements of the patients' narratives, to classify the provide narrative as either migraine or cluster headache.
Higher F1-scores suggest better classification results.
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Baseline
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BC-08263
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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