MigraineNCT01080287
The Identification and Characterization of Autonomic Dysfunction in Migraineurs With and Without Auras
An observational study of Migraine, run by The Cleveland Clinic at 1 site in United States.
Trial summary
This is a study to compare subject response and symptoms resulting from administration of three clinical assessments. The 3 assessments are 1. passive upright tilt table testing, 2. quantitative sudomotor axon reflex testing (QSART)and 3. punch biopsy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Sep 2011
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult Migraineurs with and without auras, half having orthostatic intolerance.
Who may be able to join
- age 18 to 65
- male or female
- migraine diagnosis
- may or may not have orthostatic intolerance
- able to demonstrate study understanding and complete informed consent process
Who cannot join
- subjects who do not meet inclusion criteria
- subjects unable to complete informed consent process
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic NI, Center for Headache and Pain, Desk T-33, 9500 Euclid Avenue
Cleveland, Ohio, 44195
About this study
This is a study to compare subject response and symptoms resulting from administration of three clinical assessments.
- The 3 assessments are
- passive upright tilt table testing,
- quantitative sudomotor axon reflex testing (QSART)and
- punch biopsy.
The comparison of results will be from two subject groups:
- Group A, the migraine suffering patient with or without aura
- Group B, the migraine suffering patient with or without aura who has diagnosed orthostatic intolerance (i.e.,feeling dizzy or faint when making a body position change).
- Conditions
- Migraine
- Keywords
- autonomic, orthostatic, syncope, biopsy, prevalence of autonomic dysfunction in migraineurs with orthostatic intolerance, characterize autonomic findings utilizing neurocardiac testing, neurophysiological testing and skin biopsies to analyze autonomic fibers in the dermis
- Medical subject headings
- Migraine Disorders, Syncope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Migraineurs with & w/out auras having orthostatic intolerance | Subjects between ages 18 and 65, having ICHD-II classification of migraine with or without aura, having symptoms of orthostatic intolerance | |
| Migraineurs with or without auras | Subjects between ages 18 and 65 having ICHD-II classification of migraine with or without auras |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2010 (estimated)
- Study startSep 2009
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01080287
- Sponsor's protocol ID
- 08-778
- Status last verified
- Feb 2012
- First submitted
- 2 Mar 2010
- Last updated
- 22 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Low PA, Opfer-Gehrking TL, Textor SC, Benarroch EE, Shen WK, Schondorf R, Suarez GA, Rummans TA. Postural tachycardia syndrome (POTS). Neurology. 1995 Apr;45(4 Suppl 5):S19-25.
PubMed 7746369Fouad FM, Tadena-Thome L, Bravo EL, Tarazi RC. Idiopathic hypovolemia. Ann Intern Med. 1986 Mar;104(3):298-303. doi: 10.7326/0003-4819-104-3-298.
PubMed 3511818McCarthy BG, Hsieh ST, Stocks A, Hauer P, Macko C, Cornblath DR, Griffin JW, McArthur JC. Cutaneous innervation in sensory neuropathies: evaluation by skin biopsy. Neurology. 1995 Oct;45(10):1848-55. doi: 10.1212/wnl.45.10.1848.
PubMed 7477980Headache Classification Subcommittee of the International Headache Society. The International Classification of Headache Disorders: 2nd edition. Cephalalgia. 2004;24 Suppl 1:9-160. doi: 10.1111/j.1468-2982.2003.00824.x. No abstract available.
PubMed 14979299
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Identification and Characterization of Autonomic Dysfunction in Migraineurs With and Without Auras
- ClinicalTrials.gov ID
- NCT01080287
- Acronym / sponsor ID
- 08-778
- Conditions
- Migraine
- Keywords
- autonomic, orthostatic, syncope, biopsy, prevalence of autonomic dysfunction in migraineurs with orthostatic intolerance, characterize autonomic findings utilizing neurocardiac testing, neurophysiological testing and skin biopsies to analyze autonomic fibers in the dermis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 4 Mar 2010 (estimated)
- 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.
This is a study to compare subject response and symptoms resulting from administration of three clinical assessments.
- The 3 assessments are
- passive upright tilt table testing,
- quantitative sudomotor axon reflex testing (QSART)and
- punch biopsy.
The comparison of results will be from two subject groups:
- Group A, the migraine suffering patient with or without aura
- Group B, the migraine suffering patient with or without aura who has diagnosed orthostatic intolerance (i.e.,feeling dizzy or faint when making a body position change).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Migraineurs with & w/out auras having orthostatic intolerance | – | –Subjects between ages 18 and 65, having ICHD-II classification of migraine with or without aura, having symptoms of orthostatic intolerance |
| Migraineurs with or without auras | – | –Subjects between ages 18 and 65 having ICHD-II classification of migraine with or without auras |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult Migraineurs with and without auras, half having orthostatic intolerance.
Key inclusion criteria (5 listed)
- age 18 to 65
- male or female
- migraine diagnosis
- may or may not have orthostatic intolerance
- able to demonstrate study understanding and complete informed consent process
Key exclusion criteria (2 listed)
- subjects who do not meet inclusion criteria
- subjects unable to complete informed consent process
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2012.
- Background: PubMed 7746369Low PA, Opfer-Gehrking TL, Textor SC, Benarroch EE, Shen WK, Schondorf R, Suarez GA, Rummans TA. Postural tachycardia syndrome (POTS). Neurology. 1995 Apr;45(4 Suppl 5):S19-25.
- Background: PubMed 3511818Fouad FM, Tadena-Thome L, Bravo EL, Tarazi RC. Idiopathic hypovolemia. Ann Intern Med. 1986 Mar;104(3):298-303. doi: 10.7326/0003-4819-104-3-298.
- Background: PubMed 7477980McCarthy BG, Hsieh ST, Stocks A, Hauer P, Macko C, Cornblath DR, Griffin JW, McArthur JC. Cutaneous innervation in sensory neuropathies: evaluation by skin biopsy. Neurology. 1995 Oct;45(10):1848-55. doi: 10.1212/wnl.45.10.1848.
- Background: PubMed 14979299Headache Classification Subcommittee of the International Headache Society. The International Classification of Headache Disorders: 2nd edition. Cephalalgia. 2004;24 Suppl 1:9-160. doi: 10.1111/j.1468-2982.2003.00824.x. No abstract available.
Related trials for Migraine
RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by The Cleveland Clinic at 1 site in United States.
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 22 Feb 2012. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01080287, which also lists 4 linked publications.
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 22 Feb 2012.