NCT03772860

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2018

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

December 5, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 11, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

December 11, 2018

Status Verified

December 1, 2018

Enrollment Period

1 year

First QC Date

December 5, 2018

Last Update Submit

December 10, 2018

Conditions

Migraine Disorders

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Defining differences between sympathetic skin response in migraineurs

    One year

Study Arms (4)

Healthy volunteers

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

Other: Pain stimulationOther: Visual stimulationOther: Auditory stimulationOther: Mental stress

Left headache

Migraine patients with mostly left sided headache will be exposed to pain stimulation, visual stimulation, auditory stimulation and mental stress

Other: Pain stimulationOther: Visual stimulationOther: Auditory stimulationOther: Mental stress

Right headache

Migraine patients with mostly right sided headache will be exposed to pain stimulation, visual stimulation, auditory stimulation and mental stress

Other: Pain stimulationOther: Visual stimulationOther: Auditory stimulationOther: Mental stress

Bilateral headache

Migraine patients without a dominant side headache will be exposed to pain stimulation, visual stimulation, auditory stimulation and mental stress

Other: Pain stimulationOther: Visual stimulationOther: Auditory stimulationOther: Mental stress

Interventions

Pain stimulationOTHER

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

Bilateral headacheHealthy volunteersLeft headacheRight headache
Visual stimulationOTHER

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

Bilateral headacheHealthy volunteersLeft headacheRight headache
Auditory stimulationOTHER

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

Bilateral headacheHealthy volunteersLeft headacheRight headache
Mental stressOTHER

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

Bilateral headacheHealthy volunteersLeft headacheRight headache

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients suffering migraine attending our Neurology Clinic and healthy volunteers

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

Photic StimulationAcoustic Stimulation

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Physical StimulationInvestigative TechniquesTherapeuticsSensory Art TherapiesComplementary Therapies

Study Officials

  • Yaron River, MD

    Hillel Yaffe Medical Center

    STUDY DIRECTOR

Central Study Contacts

Erel Domany, MD

CONTACT

972-52-6134235erel.domany@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2018

First Posted

December 11, 2018

Study Start

December 1, 2018

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

December 11, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)