Migraine With AuraNCT05332431
Optical Coherence Tomography Findings in Migraine
An observational study of Migraine With Aura and Migraine Without Aura, run by Assiut University.
Trial summary
This study aims to detect changes in RNFL thickness in patients with different types of migraine in comparison to healthy control. This will be accomplished by comparing the optic nerve head (ONH) parameters, RNFL thickness, and ocular perfusion pressure (OPP) in migraine patients with age and sex matched healthy… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine With Aura, Migraine Without Aura
- What is being tested?
- Optical coherence tomography (OCT)
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Apr 2022to 1 Jun 2023
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. Patients diagnosed with migraine based on prespecified criteria according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3) established by established by the International Headache Society, for migraine with aura and migraine without aura, attending the neurology outpatient clinic, Assiut University. 2. Age and sex matched healthy control group (with the absence of any pathological headache and eye problems), will be recruited from the outpatient clinic for comparison.
Who may be able to join
- All patients fulfill the criteria of case definition of migraine with aura and migraine without aura.
- Gender: both sexes are included.
- Willingness to participate in the study and to be subjected to the disease-related examinations and assessments.
- Willing and able to provide informed consent
Who cannot join
- Unable to give informed consent.
- History of chronic psychiatric or neurological disorder as patients with history of central nervous system disorders including brain tumours, infarction, epilepsy, Alzheimer's disease, and any type of headache except for migraine.
- Patients with known systemic diseases (such as diabetes mellitus and hypertension).
- Patients with known ophthalmic disorders, refractive error exceeding ± 3.0 diopters and had previously undergone any type of eye surgery. Those with optic disc anomaly, hazy media, and any retinal disease
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Optical Coherence Tomography Findings in Patients With Different Types of Migraine
This study aims to detect changes in RNFL thickness in patients with different types of migraine in comparison to healthy control. This will be accomplished by comparing the optic nerve head (ONH) parameters, RNFL thickness, and ocular perfusion pressure (OPP) in migraine patients with age and sex matched healthy control.
Read the detailed description
Migraine is a complex, neurological disorder with a genetic basis . It a primary type of headache that characterized by moderate to severe intensity pain associated with fatigue, depression, hyperactivity, nausea, sensitivity to light or sound and other neurological symptoms . The international classification of headaches divides migraine into two main types: migraine without aura and migraine with aura.
It affects a large range of individuals, although it more commonly begins in the first few decades of life . According to World Health Organization data, migraine has become the third most common disease in the 21st century . In the meantime, migraine is one of the top ten causes of disability in the world . Based on the WHO reports, Atlas of Headache Disorders and Resources in the World 2011, migraine affects 11% of adults worldwide, and females have three times higher prevalence than males, and it is the leading cause of years lost due to disability in individuals aged 15 to 49 years. Migraine has generally increased in incidence worldwide in recent years, especially in developing countries, possibly with adverse lifestyle changes brought about by rapid urbanization in these regions.
There is no consensus on the pathogenesis of migraine, but it is generally accepted that migraine is caused by the combined involvement of nerves and blood vessels . Cortical spreading depression (CSD) has been known to play an important role in the pathogenesis of migraine, which can activate and sensitize the trigeminal vascular system (TGVS), then triggers migraine-associated neurological and vascular responses, and finally induces pain. There are four potential phases of migraine have been identified, including the premonitory phase, aura, headache, and the postdrome, and these are not necessarily linear in occurrence. A better comprehension of the underlying pathophysiology of these phases has led to, for the first time in history, new preventive treatments coming out tailored specifically to treat the mechanism of migraine.
Although migraine is a transient phenomenon of cerebral vasoconstriction, transitory and recurrent constriction of the retinal and ciliary arteries may cause ischemic damage to the optic nerve, retina, and choroid in patients with migraine . There is evidence that ganglion cell death in migraine patients may be secondary to alterations in the microcirculation of the optic nerve head or even in the quality of retinal perfusion Though brain and retina come from the same embryologic origin, retina provides a unique window into the nervous system because of having unmyelinated axons and a low concentration of glial cells. That is why retina is called "a relative vacuum" while studying neurons and axons and it can serve as a valuable surrogate marker of neurodegeneration and neuroprotection.
Optical coherence tomography (OCT) was developed as a noninvasive technique for acquiring in vivo cross-sectional images during the 1980s and 1990s . Over the last 20 years, OCT has been extensively applied by ophthalmologists to study ocular pathologies, but in these days, it is also being used by neurologists and was studied as a biomarker in various neurologic conditions.
There are many studies investigated the altered retinal nerve fiber layer (RNFL) thickness by using OCT in migraine patients but the findings were inconsistent. Some studies reported reduction of RNFL thickness in patient with migraine. While other studies reported normal thickness of RNFL and did not find any statistically significant change in RNFL thickness between different types of migraine and between migraine and control groups. The present study aims to detect changes in RNFL thickness in patients with different types of migraine in comparison to healthy control.
- Conditions
- Migraine With Aura, Migraine Without Aura
- Being tested
- Optical coherence tomography (OCT)
- Medical subject headings
- Migraine with Aura, Migraine without Aura
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical coherence tomography (OCT)Device
Patient with different types of migraine and age and sex matched control group will be subjected to OCT in the ophthalmology department in Assiut University Hospital to assess the following parameters:
Optic nerve head parameters and retinal nerve fibre layer thickness and measuring macular thickness in migraine patients will be measured using optical coherence tomography (OCT) after pupillary dilatation. Retinal nerve fiber layer thickness included average thickness (360° measurement), temporal quadrant thickness (316-45°), superior quadrant thickness (46-135°), nasal quadrant thickness (136-225°) and inferior quadrant thickness (226-315°) will be measured by OCT.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Migraine | Patients diagnosed with migraine based on prespecified criteria according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3) established by established by the International Headache Society, for migraine with aura and migraine without aura, attending the neurology outpatient clinic, Assiut University. Receives: Device: Optical coherence tomography (OCT) | |
| Control | Age and sex matched healthy control group (with the absence of any pathological headache and eye problems), will be recruited from the outpatient clinic for comparison. Receives: Device: Optical coherence tomography (OCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in retinal nerve fiber layer thickness (RNFL) measured by OCT.
Patient with different types of migraine and age and sex matched control group will be subjected to OCT in the ophthalmology department in Assiut University Hospital to assess the following parameters:
Optic nerve head parameters and retinal nerve fibre layer thickness and measuring macular thickness in migraine patients will be measured using optical coherence tomography (OCT) after pupillary dilatation. Retinal nerve fiber layer thickness included average thickness (360° measurement), temporal quadrant thickness (316-45°), superior quadrant thickness (46-135°), nasal quadrant thickness (136-225°) and inferior quadrant thickness (226-315°) will be measured by OCT.
Measured: Baseline
Secondary outcomes (1)
Correlations of OCT findings in patients with migraine with migraine severity.
Correlate the findings of OCT with the severity of the migraine
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study startApr 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Migraine With AuraStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emad El din Mahmoud Taher, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05332431
- Sponsor's protocol ID
- OCT in migraine
- Status last verified
- Apr 2022
- First submitted
- 13 Dec 2021
- Last updated
- 18 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Qubty W, Patniyot I. Migraine Pathophysiology. Pediatr Neurol. 2020 Jun;107:1-6. doi: 10.1016/j.pediatrneurol.2019.12.014. Epub 2020 Feb 4.
PubMed 32192818Giffin NJ, Ruggiero L, Lipton RB, Silberstein SD, Tvedskov JF, Olesen J, Altman J, Goadsby PJ, Macrae A. Premonitory symptoms in migraine: an electronic diary study. Neurology. 2003 Mar 25;60(6):935-40. doi: 10.1212/01.wnl.0000052998.58526.a9.
PubMed 12654956Vecchia D, Pietrobon D. Migraine: a disorder of brain excitatory-inhibitory balance? Trends Neurosci. 2012 Aug;35(8):507-20. doi: 10.1016/j.tins.2012.04.007. Epub 2012 May 24.
PubMed 22633369Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.
PubMed 29368949Barnett R. Migraine. Lancet. 2019 Nov 23;394(10212):1897. doi: 10.1016/S0140-6736(19)32763-1. Epub 2019 Nov 21. No abstract available.
PubMed 31982043Buse DC, Silberstein SD, Manack AN, Papapetropoulos S, Lipton RB. Psychiatric comorbidities of episodic and chronic migraine. J Neurol. 2013 Aug;260(8):1960-9. doi: 10.1007/s00415-012-6725-x. Epub 2012 Nov 7.
PubMed 23132299Wang SJ, Chen PK, Fuh JL. Comorbidities of migraine. Front Neurol. 2010 Aug 23;1:16. doi: 10.3389/fneur.2010.00016. eCollection 2010.
PubMed 21188255Michael NDB, Hussein A, Abd Halim S, Ab Hamid SA. Evaluation of Optic Nerve Head Parameters, Retinal Nerve Fiber Layer Thickness, and Ocular Perfusion Pressure in Migraine Patients. Cureus. 2019 May 4;11(5):e4599. doi: 10.7759/cureus.4599.
PubMed 31309023Steiner TJ, Stovner LJ, Vos T, Jensen R, Katsarava Z. Migraine is first cause of disability in under 50s: will health politicians now take notice? J Headache Pain. 2018 Feb 21;19(1):17. doi: 10.1186/s10194-018-0846-2. No abstract available.
PubMed 29468450GBD 2016 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017 Sep 16;390(10100):1211-1259. doi: 10.1016/S0140-6736(17)32154-2.
PubMed 28919117GBD 2015 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016 Oct 8;388(10053):1545-1602. doi: 10.1016/S0140-6736(16)31678-6.
PubMed 27733282Woldeamanuel YW, Cowan RP. Migraine affects 1 in 10 people worldwide featuring recent rise: A systematic review and meta-analysis of community-based studies involving 6 million participants. J Neurol Sci. 2017 Jan 15;372:307-315. doi: 10.1016/j.jns.2016.11.071. Epub 2016 Dec 3.
PubMed 28017235Burstein R, Noseda R, Borsook D. Migraine: multiple processes, complex pathophysiology. J Neurosci. 2015 Apr 29;35(17):6619-29. doi: 10.1523/JNEUROSCI.0373-15.2015.
PubMed 25926442Goadsby PJ, Charbit AR, Andreou AP, Akerman S, Holland PR. Neurobiology of migraine. Neuroscience. 2009 Jun 30;161(2):327-41. doi: 10.1016/j.neuroscience.2009.03.019. Epub 2009 Mar 19.
PubMed 19303917Cutrer FM. Pathophysiology of migraine. Semin Neurol. 2010 Apr;30(2):120-30. doi: 10.1055/s-0030-1249222. Epub 2010 Mar 29.
PubMed 20352582
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography Findings in Patients With Different Types of Migraine
- ClinicalTrials.gov ID
- NCT05332431
- Acronym / sponsor ID
- OCT in migraine
- Conditions
- Migraine With Aura, Migraine Without Aura
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Apr 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 18 Apr 2022 (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.
This study aims to detect changes in RNFL thickness in patients with different types of migraine in comparison to healthy control. This will be accomplished by comparing the optic nerve head (ONH) parameters, RNFL thickness, and ocular perfusion pressure (OPP) in migraine patients with age and sex matched healthy control.
Detailed description
Migraine is a complex, neurological disorder with a genetic basis . It a primary type of headache that characterized by moderate to severe intensity pain associated with fatigue, depression, hyperactivity, nausea, sensitivity to light or sound and other neurological symptoms . The international classification of headaches divides migraine into two main types: migraine without aura and migraine with aura.
It affects a large range of individuals, although it more commonly begins in the first few decades of life . According to World Health Organization data, migraine has become the third most common disease in the 21st century . In the meantime, migraine is one of the top ten causes of disability in the world . Based on the WHO reports, Atlas of Headache Disorders and Resources in the World 2011, migraine affects 11% of adults worldwide, and females have three times higher prevalence than males, and it is the leading cause of years lost due to disability in individuals aged 15 to 49 years. Migraine has generally increased in incidence worldwide in recent years, especially in developing countries, possibly with adverse lifestyle changes brought about by rapid urbanization in these regions.
There is no consensus on the pathogenesis of migraine, but it is generally accepted that migraine is caused by the combined involvement of nerves and blood vessels . Cortical spreading depression (CSD) has been known to play an important role in the pathogenesis of migraine, which can activate and sensitize the trigeminal vascular system (TGVS), then triggers migraine-associated neurological and vascular responses, and finally induces pain. There are four potential phases of migraine have been identified, including the premonitory phase, aura, headache, and the postdrome, and these are not necessarily linear in occurrence. A better comprehension of the underlying pathophysiology of these phases has led to, for the first time in history, new preventive treatments coming out tailored specifically to treat the mechanism of migraine.
Although migraine is a transient phenomenon of cerebral vasoconstriction, transitory and recurrent constriction of the retinal and ciliary arteries may cause ischemic damage to the optic nerve, retina, and choroid in patients with migraine . There is evidence that ganglion cell death in migraine patients may be secondary to alterations in the microcirculation of the optic nerve head or even in the quality of retinal perfusion Though brain and retina come from the same embryologic origin, retina provides a unique window into the nervous system because of having unmyelinated axons and a low concentration of glial cells. That is why retina is called "a relative vacuum" while studying neurons and axons and it can serve as a valuable surrogate marker of neurodegeneration and neuroprotection.
Optical coherence tomography (OCT) was developed as a noninvasive technique for acquiring in vivo cross-sectional images during the 1980s and 1990s . Over the last 20 years, OCT has been extensively applied by ophthalmologists to study ocular pathologies, but in these days, it is also being used by neurologists and was studied as a biomarker in various neurologic conditions.
There are many studies investigated the altered retinal nerve fiber layer (RNFL) thickness by using OCT in migraine patients but the findings were inconsistent. Some studies reported reduction of RNFL thickness in patient with migraine. While other studies reported normal thickness of RNFL and did not find any statistically significant change in RNFL thickness between different types of migraine and between migraine and control groups. The present study aims to detect changes in RNFL thickness in patients with different types of migraine in comparison to healthy control.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Migraine | – | Device: Optical coherence tomography (OCT)Patients diagnosed with migraine based on prespecified criteria according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3) established by established by the International Headache Society, for migraine with aura and migraine without aura, attending the neurology outpatient clinic, Assiut University. |
| Control | – | Device: Optical coherence tomography (OCT)Age and sex matched healthy control group (with the absence of any pathological headache and eye problems), will be recruited from the outpatient clinic for comparison. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Patients diagnosed with migraine based on prespecified criteria according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3) established by established by the International Headache Society, for migraine with aura and migraine without aura, attending the neurology outpatient clinic, Assiut University. 2. Age and sex matched healthy control group (with the absence of any pathological headache and eye problems), will be recruited from the outpatient clinic for comparison.
Key inclusion criteria (4 listed)
- All patients fulfill the criteria of case definition of migraine with aura and migraine without aura.
- Gender: both sexes are included.
- Willingness to participate in the study and to be subjected to the disease-related examinations and assessments.
- Willing and able to provide informed consent
Key exclusion criteria (4 listed)
- Unable to give informed consent.
- History of chronic psychiatric or neurological disorder as patients with history of central nervous system disorders including brain tumours, infarction, epilepsy, Alzheimer's disease, and any type of headache except for migraine.
- Patients with known systemic diseases (such as diabetes mellitus and hypertension).
- Patients with known ophthalmic disorders, refractive error exceeding ± 3.0 diopters and had previously undergone any type of eye surgery. Those with optic disc anomaly, hazy media, and any retinal disease
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 |
|---|---|---|
| Optical coherence tomography (OCT)Patient with different types of migraine and age and sex matched control group will be subjected to OCT in the ophthalmology department in Assiut University Hospital to assess the following parameters: Optic nerve head parameters and retinal nerve fibre layer thickness and measuring macular thickness in migraine patients will be measured using optical coherence tomography (OCT) after pupillary dilatation. Retinal nerve fiber layer thickness included average thickness (360° measurement), temporal quadrant thickness (316-45°), superior quadrant thickness (46-135°), nasal quadrant thickness (136-225°) and inferior quadrant thickness (226-315°) will be measured by OCT. | Device | Control, Patients with Migraine |
Primary outcome
Changes in retinal nerve fiber layer thickness (RNFL) measured by OCT.
Time frame: Baseline
Patient with different types of migraine and age and sex matched control group will be subjected to OCT in the ophthalmology department in Assiut University Hospital to assess the following parameters: Optic nerve head parameters and retinal nerve fibre layer thickness and measuring macular thickness in migraine patients will be measured using optical coherence tomography (OCT) after pupillary dilatation. Retinal nerve fiber layer thickness included average thickness (360° measurement), temporal quadrant thickness (316-45°), superior quadrant thickness (46-135°), nasal quadrant thickness (136-225°) and inferior quadrant thickness (226-315°) will be measured by OCT.
1 secondary outcome
Correlations of OCT findings in patients with migraine with migraine severity.
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2022.
- Background: PubMed 32192818Qubty W, Patniyot I. Migraine Pathophysiology. Pediatr Neurol. 2020 Jun;107:1-6. doi: 10.1016/j.pediatrneurol.2019.12.014. Epub 2020 Feb 4.
- Background: PubMed 12654956Giffin NJ, Ruggiero L, Lipton RB, Silberstein SD, Tvedskov JF, Olesen J, Altman J, Goadsby PJ, Macrae A. Premonitory symptoms in migraine: an electronic diary study. Neurology. 2003 Mar 25;60(6):935-40. doi: 10.1212/01.wnl.0000052998.58526.a9.
- Background: PubMed 22633369Vecchia D, Pietrobon D. Migraine: a disorder of brain excitatory-inhibitory balance? Trends Neurosci. 2012 Aug;35(8):507-20. doi: 10.1016/j.tins.2012.04.007. Epub 2012 May 24.
- Background: PubMed 29368949Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.
- Background: PubMed 31982043Barnett R. Migraine. Lancet. 2019 Nov 23;394(10212):1897. doi: 10.1016/S0140-6736(19)32763-1. Epub 2019 Nov 21. No abstract available.
- Background: PubMed 23132299Buse DC, Silberstein SD, Manack AN, Papapetropoulos S, Lipton RB. Psychiatric comorbidities of episodic and chronic migraine. J Neurol. 2013 Aug;260(8):1960-9. doi: 10.1007/s00415-012-6725-x. Epub 2012 Nov 7.
- Background: PubMed 21188255Wang SJ, Chen PK, Fuh JL. Comorbidities of migraine. Front Neurol. 2010 Aug 23;1:16. doi: 10.3389/fneur.2010.00016. eCollection 2010.
- Background: PubMed 31309023Michael NDB, Hussein A, Abd Halim S, Ab Hamid SA. Evaluation of Optic Nerve Head Parameters, Retinal Nerve Fiber Layer Thickness, and Ocular Perfusion Pressure in Migraine Patients. Cureus. 2019 May 4;11(5):e4599. doi: 10.7759/cureus.4599.
- Background: PubMed 29468450Steiner TJ, Stovner LJ, Vos T, Jensen R, Katsarava Z. Migraine is first cause of disability in under 50s: will health politicians now take notice? J Headache Pain. 2018 Feb 21;19(1):17. doi: 10.1186/s10194-018-0846-2. No abstract available.
- Background: PubMed 28919117GBD 2016 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017 Sep 16;390(10100):1211-1259. doi: 10.1016/S0140-6736(17)32154-2.
- Background: PubMed 27733282GBD 2015 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016 Oct 8;388(10053):1545-1602. doi: 10.1016/S0140-6736(16)31678-6.
- Background: PubMed 28017235Woldeamanuel YW, Cowan RP. Migraine affects 1 in 10 people worldwide featuring recent rise: A systematic review and meta-analysis of community-based studies involving 6 million participants. J Neurol Sci. 2017 Jan 15;372:307-315. doi: 10.1016/j.jns.2016.11.071. Epub 2016 Dec 3.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine With Aura and Migraine Without Aura, run by Assiut University.
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 4 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: status not confirmed, as of the sponsor's last update on 18 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Reda B Abdelrasoul, professor (01008336450, redaalbadry02@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in retinal nerve fiber layer thickness (RNFL) measured by OCT. (time frame: Baseline). 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 NCT05332431, which also lists 30 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 18 Apr 2022.