NCT05153876

Brief Summary

Headache disorders are among the most prevalent medical conditions worldwide. The diagnosis of headache disorders is based on medical history taking. Digital solutions such as natural language processing (NLP) may be of aid to understand the linguistic aspects of headache attack and headache related disability descriptions by patients. Participants will provide a written description of their headache disorder. The results will hopefully lead to a better understanding of the potential use of NLP in headache disorders.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,150

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

October 1, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

October 11, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 10, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

2.2 years

First QC Date

October 1, 2021

Last Update Submit

May 14, 2024

Conditions

Keywords

MigraineNatural Language ProcessingHeadache

Outcome Measures

Primary Outcomes (1)

  • Lexical diversity and differences between migraine and cluster headache

    Chi-square measurement of a word token used by migraine patients versus cluster headache patients

    through study completion, an average of 1 year

Secondary Outcomes (9)

  • Accuracy of machine learning experiments for the correct classification of headache disorders

    through study completion, an average of 1 year

  • F1 scores of machine learning experiments for the correct classification of headache disorders

    through study completion, an average of 1 year

  • Word counts

    through study completion, an average of 1 year

  • Sentences counts

    through study completion, an average of 1 year

  • Paragraph counts

    through study completion, an average of 1 year

  • +4 more secondary outcomes

Study Arms (1)

Participants

Participants filling in the questionnaires

Other: Questionnaires

Interventions

Headache attack descriptions, Headache related disability descriptions, Questionnaires, MIDAS, MSQv2.1, SF36

Participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with headache disorders

You may qualify if:

  • year or older
  • Have a headache disorder with at least one headache attack over the last three months
  • voluntary participation
  • accepted the patient information sheet and gave informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, Ghent: Department of Neurology

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Headache DisordersTension-Type HeadacheMigraine DisordersCluster HeadacheHeadache Disorders, SecondaryHeadache

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesHeadache Disorders, PrimaryTrigeminal Autonomic CephalalgiasPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2021

First Posted

December 10, 2021

Study Start

October 11, 2021

Primary Completion

December 31, 2023

Study Completion

January 1, 2024

Last Updated

May 16, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations