Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05377437 |
Other study ID # |
BC-08263 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
August 28, 2020 |
Est. completion date |
December 31, 2023 |
Study information
Verified date |
May 2024 |
Source |
University Hospital, Ghent |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Headache disorders are diagnosed by clinical history taking and applying the criteria
provided within the International Classification of Headache Disorders Third Edition
(ICHD-3). To help patients and physicians in making the correct diagnosis, digital
technologies based on natural language processing (NLP) approaches may help to identify
headache disorders within naturally patient-provided speech. The research aims to develop
statistical models through machine-learning NLP applications for the accurate and precise
classification of headache disorders with headache expert given ICHD-3 diagnosis as the gold
standard. Furthermore, the research also aims to develop statistical models through
machine-learning NLP applications for the estimation of impact scores derived from validated
headache questionnaires by using texts as input. Patients from the tertiary headache clinic
will be recruited to provide oral narrative textual descriptions of their headache attack
characteristics and burden of disease related to their headache disorders. The goal of the
research is to develop accessible, evidence-based digital medical tools as low-effort
applications for the correct diagnosis of headache disorders and estimation of burden of
disease due to headache disorders.
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.