Headache DisordersNLPH-OPENNCT05153876
An Open Internet-based Survey and Natural Language Processing Project Analysing Written Monologues by Headache Patients
An observational study of Headache Disorders and Tension-Type Headache, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Headache Disorders, Tension-Type Headache, Migraine Disorders
- What is being tested?
- Questionnaires
- How many people
- 1,150 participants
- Where
- 1 siteBelgium
- Study dates
- 11 Oct 2021to 1 Jan 2024
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with headache disorders
Who may be able to join
- 18 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: NLP Headache Open: an Open Internet-based Survey and Natural Language Processing Project Analysing Written Monologues by Headache Patients
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.
- Conditions
- Headache Disorders, Tension-Type Headache, Migraine Disorders, Cluster Headache, TACS, Secondary Headache Disorder
- Being tested
- Questionnaires
- Keywords
- Migraine, Natural Language Processing, Headache
- Medical subject headings
- Headache Disorders, Tension-Type Headache, Migraine Disorders, Cluster Headache, Headache Disorders, Secondary, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Headache attack descriptions, Headache related disability descriptions, Questionnaires, MIDAS, MSQv2.1, SF36
| Study group | Role | What they receive |
|---|---|---|
| Participants | Participants filling in the questionnaires Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lexical diversity and differences between migraine and cluster headache
Chi-square measurement of a word token used by migraine patients versus cluster headache patients
Measured: through study completion, an average of 1 year
Secondary outcomes (9)
Accuracy of machine learning experiments for the correct classification of headache disorders
Machine learning experiments to investigate the potential to build modelling algorithms that accurately classify the self-given diagnosis by the patient based on text.
Measured: through study completion, an average of 1 year
F1 scores of machine learning experiments for the correct classification of headache disorders
Machine learning experiments to investigate the potential to build modelling algorithms that accurately classify the self-given diagnosis by the patient based on text.
Measured: through study completion, an average of 1 year
Word counts
Counts of word tokens of different headache disorder groups
Measured: through study completion, an average of 1 year
Sentences counts
Counts of sentence tokens of different headache disorder groups
Measured: through study completion, an average of 1 year
Paragraph counts
Counts of paragraph tokens of different headache disorder groups
Measured: through study completion, an average of 1 year
Term-frequency inverse document frequency scores (TF-IDF)
TF-IDF scores of word tokens of different headache disorder groups
Measured: through study completion, an average of 1 year
Migraine Disabillity Assessment [MIDAS] score calculation with text input
Machine learning experiments to investigate the potential to build modelling algorithms that accurately predict the impact score from Migraine Disabillity Assessment [MIDAS] based on text.
Measured: through study completion, an average of 1 year
Migraine Specific Questionaire versie 2.1 [MSQv2.1] score calculation with text input
Machine learning experiments to investigate the potential to build modelling algorithms that accurately predict the impact score from Migraine Specific Questionaire versie 2.1 [MSQv2.1] based on text.
Measured: through study completion, an average of 1 year
RAND SF-36 Dutch version score calculation with text input
Machine learning experiments to investigate the potential to build modelling algorithms that accurately predict the impact score from RAND SF-36 Dutch version based on text.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start11 Oct 2021
- Primary completion31 Dec 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Headache DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 1,150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05153876
- Sponsor's protocol ID
- BC-10635
- Acronym
- NLPH-OPEN
- Status last verified
- May 2024
- First submitted
- 1 Oct 2021
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NLP Headache Open: an Open Internet-based Survey and Natural Language Processing Project Analysing Written Monologues by Headache Patients
- ClinicalTrials.gov ID
- NCT05153876
- Acronym / sponsor ID
- NLPH-OPEN / BC-10635
- Conditions
- Headache Disorders, Tension-Type Headache, Migraine Disorders, Cluster Headache, TACS, Secondary Headache Disorder
- Keywords
- Migraine, Natural Language Processing, Headache
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,150 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 11 Oct 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 10 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Other: QuestionnairesParticipants filling in the questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with headache disorders
Key inclusion criteria (4 listed)
- 18 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesHeadache attack descriptions, Headache related disability descriptions, Questionnaires, MIDAS, MSQv2.1, SF36 | Other | Participants |
Primary outcome
Lexical diversity and differences between migraine and cluster headache
Time frame: through study completion, an average of 1 year
Chi-square measurement of a word token used by migraine patients versus cluster headache patients
9 secondary outcomes
Accuracy of machine learning experiments for the correct classification of headache disorders
Time frame: through study completion, an average of 1 year
F1 scores of machine learning experiments for the correct classification of headache disorders
Time frame: through study completion, an average of 1 year
Word counts
Time frame: through study completion, an average of 1 year
Sentences counts
Time frame: through study completion, an average of 1 year
Paragraph counts
Time frame: through study completion, an average of 1 year
Term-frequency inverse document frequency scores (TF-IDF)
Time frame: through study completion, an average of 1 year
Migraine Disabillity Assessment [MIDAS] score calculation with text input
Time frame: through study completion, an average of 1 year
Migraine Specific Questionaire versie 2.1 [MSQv2.1] score calculation with text input
Time frame: through study completion, an average of 1 year
RAND SF-36 Dutch version score calculation with text input
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Headache Disorders and Tension-Type Headache, run by University Hospital, Ghent at 1 site 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 4 inclusion and 0 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 1 site 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?
Lexical diversity and differences between migraine and cluster headache (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.