Migraine HeadacheNCT06798259
Autonomic Dysfunction in Patients With Migraine: Cardiovascular and Neurophysiology Assessment
An observational study of Migraine Headache, run by Beni-Suef University at 1 site in Egypt.
Trial summary
Autonomic dysfunction in patients with migraine: cardiovascular and neurophysiology assessment. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine Headache
- How many people
- 116 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Jan 2025to 30 Sep 2025
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: . The patients will be recruited from the Neurology clinic, Beni Suef University Hospital.
Who may be able to join
- 1.fulfilling ICHD-3 criteria for migraine 2. migraine for at least 3 months.
Who cannot join
- brain imaging showing structural brain lesions. .medications that could impact autonomic function such as tricyclic antidepressants, anticholinergics, or opioids.
- Patients with concomitant medical illness causing autonomic dysfunction such as: diabetes, cardiovascular, demyelinating or degenerative neurological disorders.
- Contraindications for performing the tilt test
- Pregnant patients.
Trial locations and contacts
1 site in 1 country.
About this study
Autonomic dysfunction in patients with migraine: cardiovascular and neurophysiology assessment.
Read the detailed description
assessment if Autonomic dysfunction in patients with migraine by using cardiovascular assessment by HOTLER MONITORING and table tilt test and neurophysiology assessment by sympathetic skin response
- Conditions
- Migraine Headache
- Medical subject headings
- Migraine Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Autonomic dysfunction in patients with migraine
assessment of autonomic dysfunction using Composite autonomic system Score 31
Measured: baseline
Secondary outcomes (1)
Cardiovascular assessment
Cardiovascular is done using Holter monitoring and table tilt est
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start7 Jan 2025
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine HeadacheStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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
- 116 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Donia Adel Abd-ElSadek, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06798259
- Sponsor's protocol ID
- FMBSUREC/01102024/Abd-Elsadek
- Status last verified
- Jan 2025
- First submitted
- 7 Jan 2025
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autonomic Dysfunction in Patients With Migraine: Cardiovascular and Neurophysiology Assessment
- ClinicalTrials.gov ID
- NCT06798259
- Acronym / sponsor ID
- FMBSUREC/01102024/Abd-Elsadek
- Conditions
- Migraine Headache
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 29 Jan 2025 (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.
Autonomic dysfunction in patients with migraine: cardiovascular and neurophysiology assessment.
Detailed description
assessment if Autonomic dysfunction in patients with migraine by using cardiovascular assessment by HOTLER MONITORING and table tilt test and neurophysiology assessment by sympathetic skin response
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Days
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- . The patients will be recruited from the Neurology clinic, Beni Suef University Hospital.
Key inclusion criteria (1 listed)
- 1.fulfilling ICHD-3 criteria for migraine 2. migraine for at least 3 months.
Key exclusion criteria (4 listed)
- brain imaging showing structural brain lesions. .medications that could impact autonomic function such as tricyclic antidepressants, anticholinergics, or opioids.
- Patients with concomitant medical illness causing autonomic dysfunction such as: diabetes, cardiovascular, demyelinating or degenerative neurological disorders.
- Contraindications for performing the tilt test
- Pregnant patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Autonomic dysfunction in patients with migraine
Time frame: baseline
assessment of autonomic dysfunction using Composite autonomic system Score 31
1 secondary outcome
Cardiovascular assessment
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
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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 Headache, run by Beni-Suef University at 1 site in Egypt.
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 1 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: under way, not looking for participants, as of the sponsor's last update on 29 Jan 2025. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
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?
Autonomic dysfunction in patients with migraine (time frame: baseline). 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 29 Jan 2025.