Defining the Sympathetic Skin Response of Migraineurs in the Facial Area

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.

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.

Study Overview

• Status: Unknown
• Conditions: Migraine Disorders
• Intervention / Treatment: Other: Pain stimulation; Other: Visual stimulation; Other: Auditory stimulation; Other: Mental stress

• Study Type: Observational
• Enrollment (Anticipated): 70

Contacts and Locations

Study Locations

• Israel
  • Hadera, Israel, 38100
    • Hillel Yaffe Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients suffering migraine attending our Neurology Clinic and healthy volunteers

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hillel Yaffe Medical Center
• Investigators: Study Director: Yaron River, MD, Hillel Yaffe Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2018
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: December 5, 2018
• First Submitted That Met QC Criteria: December 10, 2018
• First Posted (Actual): December 11, 2018

Study Record Updates

• Last Update Posted (Actual): December 11, 2018
• Last Update Submitted That Met QC Criteria: December 10, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: HYMC-113-18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No