Defining the Sympathetic Skin Response of Migraineurs in the Facial Area

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ClinicalTrials.gov Identifier: NCT03772860

Recruitment Status : Unknown

Verified December 2018 by Hillel Yaffe Medical Center.
Recruitment status was: Not yet recruiting

First Posted : December 11, 2018

Last Update Posted : December 11, 2018

Sponsor:

Information provided by (Responsible Party):

Hillel Yaffe Medical Center

Study Description

Brief 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.

Condition or disease	Intervention/treatment
Migraine Disorders	Other: Pain stimulation Other: Visual stimulation Other: Auditory stimulation Other: Mental stress

Study Design

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Study Type :	Observational
Estimated Enrollment :	70 participants
Observational Model:	Case-Control
Time Perspective:	Prospective
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.
Estimated Study Start Date :	December 2018
Estimated Primary Completion Date :	December 2019
Estimated Study Completion Date :	December 2019

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine

MedlinePlus related topics: Migraine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
Healthy volunteers Healthy volunteers will be exposed to pain stimulation, visual stimulation, auditory stimulation and mental stress	Other: Pain stimulation Pain will be simulated with an electric shock 25 mlAMP over the median nerve Other: Visual stimulation Visual stimulation will be performed by a flicker of light on a computer screen at 15 Hrz for 0.3 seconds Other: Auditory stimulation Auditory stimulation will be delivered through headphones with a sound at 500 Hrz at 85 decibels for 0.3 seconds Other: Mental stress A mathematical challenge will be displayed on a computer screen that must be quickly solved
Left headache Migraine patients with mostly left sided headache will be exposed to pain stimulation, visual stimulation, auditory stimulation and mental stress	Other: Pain stimulation Pain will be simulated with an electric shock 25 mlAMP over the median nerve Other: Visual stimulation Visual stimulation will be performed by a flicker of light on a computer screen at 15 Hrz for 0.3 seconds Other: Auditory stimulation Auditory stimulation will be delivered through headphones with a sound at 500 Hrz at 85 decibels for 0.3 seconds Other: Mental stress A mathematical challenge will be displayed on a computer screen that must be quickly solved
Right headache Migraine patients with mostly right sided headache will be exposed to pain stimulation, visual stimulation, auditory stimulation and mental stress	Other: Pain stimulation Pain will be simulated with an electric shock 25 mlAMP over the median nerve Other: Visual stimulation Visual stimulation will be performed by a flicker of light on a computer screen at 15 Hrz for 0.3 seconds Other: Auditory stimulation Auditory stimulation will be delivered through headphones with a sound at 500 Hrz at 85 decibels for 0.3 seconds Other: Mental stress A mathematical challenge will be displayed on a computer screen that must be quickly solved
Bilateral headache Migraine patients without a dominant side headache will be exposed to pain stimulation, visual stimulation, auditory stimulation and mental stress	Other: Pain stimulation Pain will be simulated with an electric shock 25 mlAMP over the median nerve Other: Visual stimulation Visual stimulation will be performed by a flicker of light on a computer screen at 15 Hrz for 0.3 seconds Other: Auditory stimulation Auditory stimulation will be delivered through headphones with a sound at 500 Hrz at 85 decibels for 0.3 seconds Other: Mental stress A mathematical challenge will be displayed on a computer screen that must be quickly solved

Outcome Measures

Primary Outcome Measures :

Defining sympathetic skin response in migraineurs [ Time Frame: One year ]
Outcome will be presented as mean sympathetic response values for all the different stimuli and then separately for each stimuli

Secondary Outcome Measures :

Defining differences between sympathetic skin response in migraineurs [ Time Frame: One year ]
Outcome will be presented as mean sympathetic response values for all the different stimuli and then separately for each stimuli

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Patients suffering migraine attending our Neurology Clinic and healthy volunteers

Criteria

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)

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03772860

Contacts

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Contact: Erel Domany, MD	972-52-6134235	erel.domany@gmail.com

Locations

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Israel
Hillel Yaffe Medical Center
Hadera, Israel, 38100
Contact: Erel Domany, MD erel.domany@gmail.com

Sponsors and Collaborators

Hillel Yaffe Medical Center

Investigators

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Study Director:	Yaron River, MD	Hillel Yaffe Medical Center

More Information

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Responsible Party:	Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:	NCT03772860
Other Study ID Numbers:	HYMC-113-18
First Posted:	December 11, 2018 Key Record Dates
Last Update Posted:	December 11, 2018
Last Verified:	December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Migraine Disorders Headache Disorders, Primary Headache Disorders	Brain Diseases Central Nervous System Diseases Nervous System Diseases

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