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NCT03772860 Clinical Trial

Defining the Sympathetic Skin Response of Migraineurs in the Facial Area

Migraine Disorders Clinical Trial

Official title:
Defining the Sympathetic Skin Response of Migraineurs in the Facial Area During the Interictal State: Comparison of Migraine Patients Who Suffer Dominant Left/Right/Bilateral Pain.

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03772860
Other study ID # HYMC-113-18
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date December 2018
Est. completion date December 2019

Study information
Verified date December 2018
Source Hillel Yaffe Medical Center
Contact Erel Domany, MD
Phone 972-52-6134235
Email erel.domany@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study is to define the sympathetic skin response of migraineurs in the facial area. This will be achieved by exposing healthy volunteers and migraine patients to various stress stimuli (pain, visual stimulation, auditory stimulation and a mathematical challenge), and recording sympathetic skin response in the facial area.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 70
Est. completion date December 2019
Est. primary completion date December 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Healthy volunteers with no history of any kind of recurrent headache

- Migraine patients according to ICH3 criteria

- Migraine patients with more than 1 attack per month

Exclusion Criteria:

- Patients with other heart or neurologic diseases

- Patients with hearing or visual decline

- Patients taking medication that effects the sympathetic system (except those taking beta blockers for migraine treatment)

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Pain stimulation
Pain will be simulated with an electric shock 25 mlAMP over the median nerve
• Visual stimulation
Visual stimulation will be performed by a flicker of light on a computer screen at 15 Hrz for 0.3 seconds
• Auditory stimulation
Auditory stimulation will be delivered through headphones with a sound at 500 Hrz at 85 decibels for 0.3 seconds
• Mental stress
A mathematical challenge will be displayed on a computer screen that must be quickly solved

Locations
Country Name City State
Israel Hillel Yaffe Medical Center Hadera

Sponsors (1)
Lead Sponsor Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Defining sympathetic skin response in migraineurs Outcome will be presented as mean sympathetic response values for all the different stimuli and then separately for each stimuli One year
Secondary Defining differences between sympathetic skin response in migraineurs Outcome will be presented as mean sympathetic response values for all the different stimuli and then separately for each stimuli One year
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