Autonomic Dysfunction in Patients With Migraine: Cardiova... | NCT06798259

Studies
Autonomic Dysfunction in Patients With Migraine: Cardiovascular and Neurophysiology Assessment

NCT06798259

Sponsor

Beni-Suef University

Status

Active, not recruiting

Last Update Posted

Jan 29, 2025Actual

Enrollment

116Estimated

Phase

Not provided

Conditions

Migraine Headache

Interventions

Not provided

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 7, 2025Actual

Primary Completion Date

Jul 30, 2025Estimated

Completion Date

Sep 30, 2025Estimated

First Submitted Date

Jan 7, 2025

First Submission Date that Met QC Criteria

Jan 22, 2025

First Posted Date

Jan 29, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 22, 2025

Last Update Posted Date

Jan 29, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Donia Adel Abd-ElSadek, Assistant teacher of anesthesiology ,pain management and surgical ICU departement, Beni-Suef UniversityPrincipal Investigator

Lead Sponsor

Beni-Suef UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

116Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Benisuef university hospital		Benisuef	Benisuef	20	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D008881	Migraine Disorders

Ancestor Terms

ID	Term
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided