MigraineNCT06304675
Manageable Environmental Factors in Migraine
An observational study of Migraine, run by Samsun University at 1 site in Turkey (Türkiye).
Trial summary
There is limited and insufficient information on the effects of inappropriate living environments, exposure to allergens, electromagnetic fields and stress factors on the chronicity of migraine. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Migraine
- How many people
- 500 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Sep 2023to 4 Mar 2024
- How long will I take part?
- 3 Months
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients diagnosed with migraine in the neurology clinic and followed up with this diagnosis and who agreed to participate in the study.
Who may be able to join
- Must be between 18-70 years old
- Clinical diagnosis of migraine
- Cognitive level to provide information about demographic and clinical features of headache
Who cannot join
- 1) Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Manageable Environmental Factors Affect Treatment Response as Much as Migraine Phenotype
There is limited and insufficient information on the effects of inappropriate living environments, exposure to allergens, electromagnetic fields and stress factors on the chronicity of migraine. The aim of this study is to investigate the frequency of environmental variables/triggers in episodic and chronic migraine patients and their relationship with clinical variables in the chronic migraine group. The results obtained will be shared not only in the scientific community, but also on workplace health and employer-related platforms, including "Wellbeing" groups.
Read the detailed description
Migraines are a prevalent and debilitating neurological condition that can significantly impact a person's quality of life. While various genetic and environmental factors contribute to the development and progression of migraines, the role of specific environmental factors/triggers in the chronification of this condition remains inadequately explored. This paper seeks to address this research gap by focusing on the impact of inadequate living environments, exposure to allergens, electromagnetic fields, and stressors on the chronification of migraines.
Obtaining specific trigger and headache information from a large number of migraineurs may provide a better understanding of which triggers are common and/or strong and which may become important only when they act together (6). With studies focusing on this issue, data that will even enable the identification of individuals with migraine who share a set of common triggers can be obtained.
Migraine attacks often begin with an episodic course and may become chronic in some individuals over time due to reasons such as drug overuse, various environmental factors and failure to take necessary steps in lifestyle regulation. Exactly when chronicity will begin in each individual and how it will progress are related to these endogenous and exogenous factors as well as the genetic structure of the individual, and how it will progress cannot be predicted.
It is difficult to study the effect of triggers on migraine attacks. Possible triggers may interact and statistical modeling is often difficult. Therefore, the estimated frequencies of precipitating factors vary considerably depending on the study approach and population. There are very few studies investigating the effects of trigger and environmental factors on the migraine phenotype. In a study where episodic and chronic migraine groups and trigger/environmental factors were evaluated in 300 women with migraine; Although some triggers have been defined for migraine, no differentiation was observed between episodic and chronic migraine groups. However, in a study conducted in 2023, endogenous and exogenous factors that may have an effect on the chronicity of migraine were evaluated. Although some triggers/environmental factors have been identified as risk factors, their likelihood of co-occurrence and clustering have not been evaluated in a large population.
In this study, the effects of triggers and environmental factors, which investigators identified with a comprehensive inquiry form, on both the pain phenotype and treatment response in migraine cases followed up in the same clinic, including episodic and chronic migraine cases, were evaluated. It is aimed to show how these factors come together in the episodic and chronic migraine group and how this affects the fate of the patient as well as the fate of the pain. Additionally, the relationship between treatment options for migraine and the responses received and environmental factors/triggers was investigated. Researching and defining all these features may be a good predictor in the chronicity of migraine, which affects many individuals, and in the regulation of environmental factors/triggers.
Materials and Methods:
Participants: Patients who were over 18 years of age, were followed up with a diagnosis of migraine, and had the cognitive level to provide information about demographic and clinical features of headache were included. International Classification of Headache Disorders-3 (ICHD-3) criteria were used for the diagnosis of chronic migraine in the study group. Having a headache more than 15 days per month for >3 months and having at least 8 headaches with migraine characteristics was defined as "chronic migraine", while those with headaches less frequently than 14 days per month were defined as "episodic migraine". All treatment options and responses received for migraine were recorded in detail. Participants who agreed to participate in the study were given a survey form containing items about migraine characteristics, triggers and environmental factors. The data form was filled in through a face-to-face interview.
2.2. Study Design: Ethics approval was received for this cross-sectional-observational study (OndokuzMayısUniversity-OMU-2023/466). The International Headache Society (IHS) is involved in the development and publication of numerous guidelines for controlled treatment trials for primary headache disorders. In the planning and implementation stages of this study, the clinical trials guideline principles of the I IHS were followed and progress was made according to the STROBE checklist. The demographic characteristics of the patients were recorded in the demographic data form. Then, the patient's headache characteristics (duration, type, presence of aura, accompanying features, etc.) and the answers to questions about possible triggers of migraine and environmental factors were recorded in the data form.
- Conditions
- Migraine
- Being tested
- no intervention
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Environmental factors/triggers affecting the chronicity of migraine
Triggers/environmental factors in individuals diagnosed with chronic migraine and episodic migraine were documented with an inquiry-survey form and demographic data form.
(The inquiry form/survey form containing the list of triggers/environmental factors can be uploaded to the system if desired) There is no scoring system in this inquiry form/survey form.
Measured: 3-months
Secondary outcomes (1)
2.Environmental factors/triggers and migraine treatment
Environmental factors/triggers that may affect migraine treatment success were evaluated with a survey form.
(The inquiry form/survey form containing the list of triggers/environmental factors can be uploaded to the system if desired) There is no scoring system in this inquiry form/survey form.
Measured: 3-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start30 Sep 2023
- Primary completion15 Feb 2024
- Study completion4 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bilge Piri Cinar, Samsun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06304675
- Sponsor's protocol ID
- 905055423985
- Status last verified
- Mar 2024
- First submitted
- 6 Feb 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data with a similar study plan can be shared within the scope of a study for big data or review/meta analysis
Publications
Spierings EL, Donoghue S, Mian A, Wober C. Sufficiency and necessity in migraine: how do we figure out if triggers are absolute or partial and, if partial, additive or potentiating? Curr Pain Headache Rep. 2014 Oct;18(10):455. doi: 10.1007/s11916-014-0455-y.
PubMed 25163437Guidelines for controlled trials of drugs in migraine. First edition. International Headache Society Committee on Clinical Trials in Migraine. Cephalalgia. 1991 Feb;11(1):1-12. No abstract available.
PubMed 2036663Tfelt-Hansen P, Block G, Dahlof C, Diener HC, Ferrari MD, Goadsby PJ, Guidetti V, Jones B, Lipton RB, Massiou H, Meinert C, Sandrini G, Steiner T, Winter PB; International Headache Society Clinical Trials Subcommittee. Guidelines for controlled trials of drugs in migraine: second edition. Cephalalgia. 2000 Nov;20(9):765-86. doi: 10.1046/j.1468-2982.2000.00117.x. No abstract available.
PubMed 11167908Hajjarzadeh S, Shalilahmadi D, Nikniaz Z, Mahdavi R, Hajjarzadeh S. The comparison of the main dietary and non-dietary trigger factors in women with chronic and episodic migraine. Nutr Diet. 2022 Nov;79(5):616-622. doi: 10.1111/1747-0080.12761. Epub 2022 Aug 18.
PubMed 35983599Lipton RB, Buse DC, Nahas SJ, Tietjen GE, Martin VT, Lof E, Brevig T, Cady R, Diener HC. Risk factors for migraine disease progression: a narrative review for a patient-centered approach. J Neurol. 2023 Dec;270(12):5692-5710. doi: 10.1007/s00415-023-11880-2. Epub 2023 Aug 24.
PubMed 37615752
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manageable Environmental Factors Affect Treatment Response as Much as Migraine Phenotype
- ClinicalTrials.gov ID
- NCT06304675
- Acronym / sponsor ID
- 905055423985
- Conditions
- Migraine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 30 Sep 2023 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 4 Mar 2024 (actual)
- First posted
- 12 Mar 2024 (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.
There is limited and insufficient information on the effects of inappropriate living environments, exposure to allergens, electromagnetic fields and stress factors on the chronicity of migraine. The aim of this study is to investigate the frequency of environmental variables/triggers in episodic and chronic migraine patients and their relationship with clinical variables in the chronic migraine group. The results obtained will be shared not only in the scientific community, but also on workplace health and employer-related platforms, including "Wellbeing" groups.
Detailed description
Migraines are a prevalent and debilitating neurological condition that can significantly impact a person's quality of life. While various genetic and environmental factors contribute to the development and progression of migraines, the role of specific environmental factors/triggers in the chronification of this condition remains inadequately explored. This paper seeks to address this research gap by focusing on the impact of inadequate living environments, exposure to allergens, electromagnetic fields, and stressors on the chronification of migraines.
Obtaining specific trigger and headache information from a large number of migraineurs may provide a better understanding of which triggers are common and/or strong and which may become important only when they act together (6). With studies focusing on this issue, data that will even enable the identification of individuals with migraine who share a set of common triggers can be obtained.
Migraine attacks often begin with an episodic course and may become chronic in some individuals over time due to reasons such as drug overuse, various environmental factors and failure to take necessary steps in lifestyle regulation. Exactly when chronicity will begin in each individual and how it will progress are related to these endogenous and exogenous factors as well as the genetic structure of the individual, and how it will progress cannot be predicted.
It is difficult to study the effect of triggers on migraine attacks. Possible triggers may interact and statistical modeling is often difficult. Therefore, the estimated frequencies of precipitating factors vary considerably depending on the study approach and population. There are very few studies investigating the effects of trigger and environmental factors on the migraine phenotype. In a study where episodic and chronic migraine groups and trigger/environmental factors were evaluated in 300 women with migraine; Although some triggers have been defined for migraine, no differentiation was observed between episodic and chronic migraine groups. However, in a study conducted in 2023, endogenous and exogenous factors that may have an effect on the chronicity of migraine were evaluated. Although some triggers/environmental factors have been identified as risk factors, their likelihood of co-occurrence and clustering have not been evaluated in a large population.
In this study, the effects of triggers and environmental factors, which investigators identified with a comprehensive inquiry form, on both the pain phenotype and treatment response in migraine cases followed up in the same clinic, including episodic and chronic migraine cases, were evaluated. It is aimed to show how these factors come together in the episodic and chronic migraine group and how this affects the fate of the patient as well as the fate of the pain. Additionally, the relationship between treatment options for migraine and the responses received and environmental factors/triggers was investigated. Researching and defining all these features may be a good predictor in the chronicity of migraine, which affects many individuals, and in the regulation of environmental factors/triggers.
Materials and Methods:
Participants: Patients who were over 18 years of age, were followed up with a diagnosis of migraine, and had the cognitive level to provide information about demographic and clinical features of headache were included. International Classification of Headache Disorders-3 (ICHD-3) criteria were used for the diagnosis of chronic migraine in the study group. Having a headache more than 15 days per month for >3 months and having at least 8 headaches with migraine characteristics was defined as "chronic migraine", while those with headaches less frequently than 14 days per month were defined as "episodic migraine". All treatment options and responses received for migraine were recorded in detail. Participants who agreed to participate in the study were given a survey form containing items about migraine characteristics, triggers and environmental factors. The data form was filled in through a face-to-face interview.
2.2. Study Design: Ethics approval was received for this cross-sectional-observational study (OndokuzMayısUniversity-OMU-2023/466). The International Headache Society (IHS) is involved in the development and publication of numerous guidelines for controlled treatment trials for primary headache disorders. In the planning and implementation stages of this study, the clinical trials guideline principles of the I IHS were followed and progress was made according to the STROBE checklist. The demographic characteristics of the patients were recorded in the demographic data form. Then, the patient's headache characteristics (duration, type, presence of aura, accompanying features, etc.) and the answers to questions about possible triggers of migraine and environmental factors were recorded in the data form.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients diagnosed with migraine in the neurology clinic and followed up with this diagnosis and who agreed to participate in the study.
Key inclusion criteria (3 listed)
- Must be between 18-70 years old
- Clinical diagnosis of migraine
- Cognitive level to provide information about demographic and clinical features of headache
Key exclusion criteria (1 listed)
- 1) Pregnancy
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 |
|---|---|---|
| no interventionno intervention | Other | – |
Primary outcome
1. Environmental factors/triggers affecting the chronicity of migraine
Time frame: 3-months
Triggers/environmental factors in individuals diagnosed with chronic migraine and episodic migraine were documented with an inquiry-survey form and demographic data form. (The inquiry form/survey form containing the list of triggers/environmental factors can be uploaded to the system if desired) There is no scoring system in this inquiry form/survey form.
1 secondary outcome
2.Environmental factors/triggers and migraine treatment
Time frame: 3-months
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 12 Mar 2024.
- Results publication: PubMed 25163437Spierings EL, Donoghue S, Mian A, Wober C. Sufficiency and necessity in migraine: how do we figure out if triggers are absolute or partial and, if partial, additive or potentiating? Curr Pain Headache Rep. 2014 Oct;18(10):455. doi: 10.1007/s11916-014-0455-y.
- Results publication: PubMed 2036663Guidelines for controlled trials of drugs in migraine. First edition. International Headache Society Committee on Clinical Trials in Migraine. Cephalalgia. 1991 Feb;11(1):1-12. No abstract available.
- Results publication: PubMed 11167908Tfelt-Hansen P, Block G, Dahlof C, Diener HC, Ferrari MD, Goadsby PJ, Guidetti V, Jones B, Lipton RB, Massiou H, Meinert C, Sandrini G, Steiner T, Winter PB; International Headache Society Clinical Trials Subcommittee. Guidelines for controlled trials of drugs in migraine: second edition. Cephalalgia. 2000 Nov;20(9):765-86. doi: 10.1046/j.1468-2982.2000.00117.x. No abstract available.
- Results publication: PubMed 35983599Hajjarzadeh S, Shalilahmadi D, Nikniaz Z, Mahdavi R, Hajjarzadeh S. The comparison of the main dietary and non-dietary trigger factors in women with chronic and episodic migraine. Nutr Diet. 2022 Nov;79(5):616-622. doi: 10.1111/1747-0080.12761. Epub 2022 Aug 18.
- Results publication: PubMed 37615752Lipton RB, Buse DC, Nahas SJ, Tietjen GE, Martin VT, Lof E, Brevig T, Cady R, Diener HC. Risk factors for migraine disease progression: a narrative review for a patient-centered approach. J Neurol. 2023 Dec;270(12):5692-5710. doi: 10.1007/s00415-023-11880-2. Epub 2023 Aug 24.
- Individual participant dataSharing planned: Undecided. Data with a similar study plan can be shared within the scope of a study for big data or review/meta analysis
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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 Migraine, run by Samsun University at 1 site in Turkey (Türkiye).
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 1 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 12 Mar 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 Turkey (Türkiye). 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?
1. Environmental factors/triggers affecting the chronicity of migraine (time frame: 3-months). 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 NCT06304675, which also lists 5 linked publications.
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 12 Mar 2024; AzTrials last refreshed its copy on 30 Oct 2026.