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Natural Language Processing for Headache Medicine

Primary Purpose

Migraine, Headache Disorders

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Natural Language Processing
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Migraine focused on measuring Headache Disorders, Natural Language Processing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Ghent University Hospital
  • University Hospital GhentRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Participants

Arm Description

Participants of the study

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 25, 2022
Last Updated
October 3, 2023
Sponsor
University Hospital, Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT05377437
Brief Title
Natural Language Processing for Headache Medicine
Official Title
Natural Language Processing for Headache Medicine
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 28, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine, Headache Disorders
Keywords
Headache Disorders, Natural Language Processing

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Participants
Arm Type
Experimental
Arm Description
Participants of the study
Intervention Type
Other
Intervention Name(s)
Natural Language Processing
Intervention Description
Natural Language Processing: classification and regression tasks.
Primary Outcome Measure Information:
Title
F1-scores classification migraine narrative versus cluster headache narrative
Description
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.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolas Vandenbussche, M.D.
Phone
+3293324529
Email
nicolas.vandenbussche@ugent.be
First Name & Middle Initial & Last Name or Official Title & Degree
Koen Paemeleire, M.D., Ph.D.
Phone
+3293324529
Email
koen.paemeleire@ugent.be
Facility Information:
Facility Name
Ghent University Hospital
City
Ghent
State/Province
Belgie
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas Vandenbussche
Phone
+32 9 332 45 88
Email
nicolas.vandenbussche@uzgent.be

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
36180844
Citation
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.
Results Reference
derived

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Natural Language Processing for Headache Medicine

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