Defining the Sympathetic Skin Response of Migraineurs in the Facial Area

NCT ID: NCT03772860

Last Updated: 2018-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-31

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Migraine Disorders

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy volunteers

Healthy volunteers will be exposed to pain stimulation, visual stimulation, auditory stimulation and mental stress

Pain stimulation

Intervention Type OTHER

Pain will be simulated with an electric shock 25 mlAMP over the median nerve

Visual stimulation

Intervention Type OTHER

Visual stimulation will be performed by a flicker of light on a computer screen at 15 Hrz for 0.3 seconds

Auditory stimulation

Intervention Type OTHER

Auditory stimulation will be delivered through headphones with a sound at 500 Hrz at 85 decibels for 0.3 seconds

Mental stress

Intervention Type OTHER

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

Pain stimulation

Intervention Type OTHER

Pain will be simulated with an electric shock 25 mlAMP over the median nerve

Visual stimulation

Intervention Type OTHER

Visual stimulation will be performed by a flicker of light on a computer screen at 15 Hrz for 0.3 seconds

Auditory stimulation

Intervention Type OTHER

Auditory stimulation will be delivered through headphones with a sound at 500 Hrz at 85 decibels for 0.3 seconds

Mental stress

Intervention Type OTHER

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

Pain stimulation

Intervention Type OTHER

Pain will be simulated with an electric shock 25 mlAMP over the median nerve

Visual stimulation

Intervention Type OTHER

Visual stimulation will be performed by a flicker of light on a computer screen at 15 Hrz for 0.3 seconds

Auditory stimulation

Intervention Type OTHER

Auditory stimulation will be delivered through headphones with a sound at 500 Hrz at 85 decibels for 0.3 seconds

Mental stress

Intervention Type OTHER

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

Pain stimulation

Intervention Type OTHER

Pain will be simulated with an electric shock 25 mlAMP over the median nerve

Visual stimulation

Intervention Type OTHER

Visual stimulation will be performed by a flicker of light on a computer screen at 15 Hrz for 0.3 seconds

Auditory stimulation

Intervention Type OTHER

Auditory stimulation will be delivered through headphones with a sound at 500 Hrz at 85 decibels for 0.3 seconds

Mental stress

Intervention Type OTHER

A mathematical challenge will be displayed on a computer screen that must be quickly solved

Interventions

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Pain stimulation

Pain will be simulated with an electric shock 25 mlAMP over the median nerve

Intervention Type OTHER

Visual stimulation

Visual stimulation will be performed by a flicker of light on a computer screen at 15 Hrz for 0.3 seconds

Intervention Type OTHER

Auditory stimulation

Auditory stimulation will be delivered through headphones with a sound at 500 Hrz at 85 decibels for 0.3 seconds

Intervention Type OTHER

Mental stress

A mathematical challenge will be displayed on a computer screen that must be quickly solved

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hillel Yaffe Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yaron River, MD

Role: STUDY_DIRECTOR

Hillel Yaffe Medical Center

Locations

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Hillel Yaffe Medical Center

Hadera, , Israel

Site Status

Countries

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Israel

Central Contacts

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Erel Domany, MD

Role: CONTACT

Phone: 972-52-6134235

Email: [email protected]

Facility Contacts

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Erel Domany, MD

Role: primary

Other Identifiers

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HYMC-113-18

Identifier Type: -

Identifier Source: org_study_id