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MigraineNCT05377437

Natural Language Processing for Headache Medicine

A study testing Natural Language Processing in people with Migraine and Headache Disorders, run by University Hospital, Ghent at 2 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Migraine, Headache Disorders
What is being tested?
Natural Language Processing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
187 participants
Where
2 sitesBelgium
Study dates
28 Aug 2020to 31 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Belgium2 sites
  • Ghent University Hospital

    Ghent, Belgie, 9000

  • University Hospital Ghent

    Ghent, 9000

Other trials in Belgium

About this study

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.

Read the 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.

Being tested
Natural Language Processing
Keywords
Headache Disorders, Natural Language Processing
Medical subject headings
Migraine Disorders, Headache Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Natural Language ProcessingOther

    Natural Language Processing: classification and regression tasks.

Study groups in NCT05377437
Study groupRoleWhat they receive
ParticipantsExperimentalParticipants of the study
Receives: Other: Natural Language Processing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. F1-scores classification migraine narrative versus cluster headache narrative

    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.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2022
  2. Study start28 Aug 2020
  3. Primary completion31 Dec 2023
  4. Study completion31 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
187 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05377437
Sponsor's protocol ID
BC-08263
Status last verified
May 2024
First submitted
25 Apr 2022
Last updated
16 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Vandenbussche N, Van Hee C, Hoste V, Paemeleire K. Using natural language processing to automatically classify written self-reported narratives by patients with migraine or cluster headache. J Headache Pain. 2022 Sep 30;23(1):129. doi: 10.1186/s10194-022-01490-0.

    PubMed 36180844

Questions about this trial

What is this clinical trial studying?

A study testing Natural Language Processing in people with Migraine and Headache Disorders, run by University Hospital, Ghent at 2 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

F1-scores classification migraine narrative versus cluster headache narrative (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05377437, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024; AzTrials last refreshed its copy on 28 Oct 2026.

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