NCT06798259

Brief Summary

Autonomic dysfunction in patients with migraine: cardiovascular and neurophysiology assessment.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
116

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

January 7, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 29, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

January 29, 2025

Status Verified

January 1, 2025

Enrollment Period

7 months

First QC Date

January 7, 2025

Last Update Submit

January 22, 2025

Conditions

Migraine Headache

Outcome Measures

Primary Outcomes (1)

  • Autonomic dysfunction in patients with migraine

    assessment of autonomic dysfunction using Composite autonomic system Score 31

    baseline

Secondary Outcomes (1)

  • Cardiovascular assessment

    24 hours

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Benisuef university hospital

Benisuef, Benisuef, 20, Egypt

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
2 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant teacher of anesthesiology ,pain management and surgical ICU departement

Study Record Dates

First Submitted

January 7, 2025

First Posted

January 29, 2025

Study Start

January 7, 2025

Primary Completion

July 30, 2025

Study Completion

September 30, 2025

Last Updated

January 29, 2025

Record last verified: 2025-01

Locations

EG(1)