NCT05377437

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
187

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 28, 2020

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

April 25, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 17, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

3.3 years

First QC Date

April 25, 2022

Last Update Submit

May 14, 2024

Conditions

Keywords

Headache DisordersNatural Language Processing

Outcome Measures

Primary Outcomes (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.

    Baseline

Study Arms (1)

Participants

EXPERIMENTAL

Participants of the study

Other: Natural Language Processing

Interventions

Natural Language Processing: classification and regression tasks.

Participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ghent University Hospital

Ghent, Belgie, 9000, Belgium

Location

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Migraine DisordersHeadache Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2022

First Posted

May 17, 2022

Study Start

August 28, 2020

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

May 16, 2024

Record last verified: 2024-05

Locations