Migraine DisordersNCT03772860
Defining the Sympathetic Skin Response of Migraineurs in the Facial Area
An observational study of Migraine Disorders, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- Pain stimulation, Visual stimulation and Auditory stimulation
- How many people
- 70 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2018to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients suffering migraine attending our Neurology Clinic and healthy volunteers
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hillel Yaffe Medical Center
Hadera, 38100
Erel Domany, MD, erel.domany@gmail.com
About this study
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.
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.
- Conditions
- Migraine Disorders
- Being tested
- Pain stimulation, Visual stimulation, Auditory stimulation, Mental stress
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain stimulationOther
Pain will be simulated with an electric shock 25 mlAMP over the median nerve
Visual stimulationOther
Visual stimulation will be performed by a flicker of light on a computer screen at 15 Hrz for 0.3 seconds
Auditory stimulationOther
Auditory stimulation will be delivered through headphones with a sound at 500 Hrz at 85 decibels for 0.3 seconds
Mental stressOther
A mathematical challenge will be displayed on a computer screen that must be quickly solved
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Healthy volunteers will be exposed to pain stimulation, visual stimulation, auditory stimulation and mental stress Receives: Other: Pain stimulation; Other: Visual stimulation; Other: Auditory stimulation; Other: Mental stress | |
| Left headache | Migraine patients with mostly left sided headache will be exposed to pain stimulation, visual stimulation, auditory stimulation and mental stress Receives: Other: Pain stimulation; Other: Visual stimulation; Other: Auditory stimulation; Other: Mental stress | |
| Right headache | Migraine patients with mostly right sided headache will be exposed to pain stimulation, visual stimulation, auditory stimulation and mental stress Receives: Other: Pain stimulation; Other: Visual stimulation; Other: Auditory stimulation; Other: Mental stress | |
| Bilateral headache | Migraine patients without a dominant side headache will be exposed to pain stimulation, visual stimulation, auditory stimulation and mental stress Receives: Other: Pain stimulation; Other: Visual stimulation; Other: Auditory stimulation; Other: Mental stress |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One year
Secondary outcomes (1)
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
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study startDec 2018 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Yaron River, MD, Study director, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03772860
- Sponsor's protocol ID
- HYMC-113-18
- Status last verified
- Dec 2018
- First submitted
- 5 Dec 2018
- Last updated
- 11 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03772860
- Acronym / sponsor ID
- HYMC-113-18
- Conditions
- Migraine Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Dec 2018 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 11 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | Other: Pain stimulation, Other: Visual stimulation, Other: Auditory stimulation, Other: Mental stressHealthy volunteers will be exposed to pain stimulation, visual stimulation, auditory stimulation and mental stress |
| Left headache | – | Other: Pain stimulation, Other: Visual stimulation, Other: Auditory stimulation, Other: Mental stressMigraine patients with mostly left sided headache will be exposed to pain stimulation, visual stimulation, auditory stimulation and mental stress |
| Right headache | – | Other: Pain stimulation, Other: Visual stimulation, Other: Auditory stimulation, Other: Mental stressMigraine patients with mostly right sided headache will be exposed to pain stimulation, visual stimulation, auditory stimulation and mental stress |
| Bilateral headache | – | Other: Pain stimulation, Other: Visual stimulation, Other: Auditory stimulation, Other: Mental stressMigraine patients without a dominant side headache will be exposed to pain stimulation, visual stimulation, auditory stimulation and mental stress |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering migraine attending our Neurology Clinic and healthy volunteers
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain stimulationPain will be simulated with an electric shock 25 mlAMP over the median nerve | Other | Bilateral headache, Healthy volunteers, Left headache, Right headache |
| Visual stimulationVisual stimulation will be performed by a flicker of light on a computer screen at 15 Hrz for 0.3 seconds | Other | Bilateral headache, Healthy volunteers, Left headache, Right headache |
| Auditory stimulationAuditory stimulation will be delivered through headphones with a sound at 500 Hrz at 85 decibels for 0.3 seconds | Other | Bilateral headache, Healthy volunteers, Left headache, Right headache |
| Mental stressA mathematical challenge will be displayed on a computer screen that must be quickly solved | Other | Bilateral headache, Healthy volunteers, Left headache, Right headache |
Primary outcome
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
1 secondary outcome
Defining differences between sympathetic skin response in migraineurs
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yaron River, MD study director
Hillel Yaffe Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine Disorders, run by Hillel Yaffe Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erel Domany, MD (972-52-6134235, erel.domany@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Defining sympathetic skin response in migraineurs (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2018.