Autonomic Dysfunction in Patients with Migraine: Cardiovascular and Neurophysiology Assessment

January 22, 2025 updated by: Donia Adel Abd-ElSadek, Beni-Suef University
Autonomic dysfunction in patients with migraine: cardiovascular and neurophysiology assessment.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

116

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Benisuef, Egypt, 20
        • Benisuef university hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

. The patients will be recruited from the Neurology clinic, Beni Suef University Hospital.

Description

Inclusion Criteria:

  • 1.fulfilling ICHD-3 criteria for migraine 2. migraine for at least 3 months.

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Autonomic dysfunction in patients with migraine
Time Frame: baseline
assessment of autonomic dysfunction using Composite autonomic system Score 31
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular assessment
Time Frame: 24 hours
Cardiovascular is done using Holter monitoring and table tilt est
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beni-Suef University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2025

Primary Completion (Estimated)

July 30, 2025

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

January 7, 2025

First Submitted That Met QC Criteria

January 22, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 22, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMBSUREC/01102024/Abd-Elsadek

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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