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Defining the Sympathetic Skin Response of Migraineurs in the Facial Area

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ClinicalTrials.gov Identifier: NCT03772860
Recruitment Status : Not yet recruiting
First Posted : December 11, 2018
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center

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 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 related topics: Migraine

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




Primary Outcome Measures :
  1. 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 :
  1. 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



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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)

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

Locations
Israel
Hillel Yaffe Medical Center Not yet recruiting
Hadera, Israel, 38100
Contact: Erel Domany, MD       erel.domany@gmail.com   
Sponsors and Collaborators
Hillel Yaffe Medical Center
Investigators
Study Director: Yaron River, MD Hillel Yaffe Medical Center

Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT03772860     History of Changes
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

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

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases