MigraineNCT03004313
Structural and Molecular Neuroplasticity in Migraine
A study testing Pet Scan, MRI scan and Quantitative Sensory Testing (QST) in people with Migraine, run by University of Michigan at 1 site in United States.
Trial summary
The main purpose of this study is to integrate novel MRI techniques with positron emission tomography(PET) for the study of structural and molecular neuroplasticity in the brain of migraineurs, and its clinical association with changes in pain perception and modulation (e.g. allodynia). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine
- What is being tested?
- Pet Scan, MRI scan and Quantitative Sensory Testing (QST)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Oct 2014
- Phase
- Interventional
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between 18-45 years of age
- Between 1-14 migraine attacks per month or healthy
Who cannot join
- Cannot be taking daily migraine medication
- Healthy subjects cannot be taking hormonal birth control pills or other medication
- Cannot have chronic pain or a neurologic/psychiatric disorder such as: multiple sclerosis and bipolar disorder.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan - Michigan Center for Oral Health Research
Ann Arbor, Michigan, 48106
About this study
The main purpose of this study is to integrate novel MRI techniques with positron emission tomography(PET) for the study of structural and molecular neuroplasticity in the brain of migraineurs, and its clinical association with changes in pain perception and modulation (e.g. allodynia). We will attempt to acquire images of the brain that may, in the future, assist doctors in better understanding how pain is felt and regulated in migraine sufferers.
Read the detailed description
To investigate interictal opioid receptor (MOR) binding potential (BPND) changes in migraineurs as compared to age/gender-matched healthy controls. To demonstrate that frequency of the headache attacks and severity of cutaneous allodynia levels in migraineurs experienced over multiple attacks are correlated with levels of MOR BPND in specific brain regions. To investigate whether dysfunction of the pain regulatory endogenous opioid system of migraineurs is correlated with changes in the gray matter thickness in cortical areas associated with pain perception and modulation.
- Conditions
- Migraine
- Being tested
- Pet Scan, MRI scan, Quantitative Sensory Testing (QST)
- Keywords
- migraine
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pet ScanProcedure or surgery
Subjects will undergo Pet Scanning for 90 minutes
MRI scanProcedure or surgery
Quantitative Sensory Testing (QST)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Migraine | Experimental | 20 subjects experiencing 1-14 migraines per month will undergo the following:
* Blood and urine samples will be collected
* Complete a series of questionnaires; some of which will be completed daily
* Quantitative Sensory Test (QST)will be performed
* Magnetic Resonance Imaging (MRI)
* PET imaging (during and outside of a migraine attack) Receives: Procedure: Pet Scan; Procedure: MRI scan; Procedure: Quantitative Sensory Testing (QST) |
| Healthy | Active comparator | 20 healthy subjects will undergo the following:
* Blood and urine samples will be collected
* Complete a series of questionnaires; some of which will be completed daily
* Quantitative Sensory Test (QST)will be performed
* Magnetic Resonance Imaging (MRI)
* PET imaging Receives: Procedure: Pet Scan; Procedure: MRI scan; Procedure: Quantitative Sensory Testing (QST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of mu-opioid receptor binding potential in the brain of episodic migraineurs during and outside the headache attack and compared to healthy controls.
Measured: 90 min PET scan
Secondary outcomes (1)
Correlation of migraine attack severity in migraineurs with mu-opioid receptor binding potential
Measured: 90 min PET scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2016 (estimated)
- Study startJan 2011
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandre DaSilva, DDS, MS, University of Michigan
- Investigators
- Alexandre DaSilva, DDS, MS, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03004313
- Sponsor's protocol ID
- HUM00027383
- Status last verified
- Nov 2017
- First submitted
- 30 Aug 2011
- Last updated
- 24 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Jassar H, Nascimento TD, Kaciroti N, DosSantos MF, Danciu T, Koeppe RA, Smith YR, Bigal ME, Porreca F, Casey KL, Zubieta JK, DaSilva AF. Impact of chronic migraine attacks and their severity on the endogenous mu-opioid neurotransmission in the limbic system. Neuroimage Clin. 2019;23:101905. doi: 10.1016/j.nicl.2019.101905. Epub 2019 Jun 18.
PubMed 31279240
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structural and Molecular Neuroplasticity in Migraine
- ClinicalTrials.gov ID
- NCT03004313
- Acronym / sponsor ID
- HUM00027383
- Conditions
- Migraine
- Keywords
- migraine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 28 Dec 2016 (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.
The main purpose of this study is to integrate novel MRI techniques with positron emission tomography(PET) for the study of structural and molecular neuroplasticity in the brain of migraineurs, and its clinical association with changes in pain perception and modulation (e.g. allodynia). We will attempt to acquire images of the brain that may, in the future, assist doctors in better understanding how pain is felt and regulated in migraine sufferers.
Detailed description
To investigate interictal opioid receptor (MOR) binding potential (BPND) changes in migraineurs as compared to age/gender-matched healthy controls. To demonstrate that frequency of the headache attacks and severity of cutaneous allodynia levels in migraineurs experienced over multiple attacks are correlated with levels of MOR BPND in specific brain regions. To investigate whether dysfunction of the pain regulatory endogenous opioid system of migraineurs is correlated with changes in the gray matter thickness in cortical areas associated with pain perception and modulation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Migraine | Experimental | Procedure: Pet Scan, Procedure: MRI scan, Procedure: Quantitative Sensory Testing (QST)20 subjects experiencing 1-14 migraines per month will undergo the following: * Blood and urine samples will be collected * Complete a series of questionnaires; some of which will be completed daily * Quantitative Sensory Test (QST)will be performed * Magnetic Resonance Imaging (MRI) * PET imaging (during and outside of a migraine attack) |
| Healthy | Active comparator | Procedure: Pet Scan, Procedure: MRI scan, Procedure: Quantitative Sensory Testing (QST)20 healthy subjects will undergo the following: * Blood and urine samples will be collected * Complete a series of questionnaires; some of which will be completed daily * Quantitative Sensory Test (QST)will be performed * Magnetic Resonance Imaging (MRI) * PET imaging |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Between 18-45 years of age
- Between 1-14 migraine attacks per month or healthy
Key exclusion criteria (3 listed)
- Cannot be taking daily migraine medication
- Healthy subjects cannot be taking hormonal birth control pills or other medication
- Cannot have chronic pain or a neurologic/psychiatric disorder such as: multiple sclerosis and bipolar disorder.
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 |
|---|---|---|
| Pet ScanSubjects will undergo Pet Scanning for 90 minutes | Procedure or surgery | Healthy, Migraine |
| MRI scan | Procedure or surgery | Healthy, Migraine |
| Quantitative Sensory Testing (QST) | Procedure or surgery | Healthy, Migraine |
Primary outcome
Level of mu-opioid receptor binding potential in the brain of episodic migraineurs during and outside the headache attack and compared to healthy controls.
Time frame: 90 min PET scan
1 secondary outcome
Correlation of migraine attack severity in migraineurs with mu-opioid receptor binding potential
Time frame: 90 min PET scan
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 24 Nov 2017.
- Derived from this study: PubMed 31279240Jassar H, Nascimento TD, Kaciroti N, DosSantos MF, Danciu T, Koeppe RA, Smith YR, Bigal ME, Porreca F, Casey KL, Zubieta JK, DaSilva AF. Impact of chronic migraine attacks and their severity on the endogenous mu-opioid neurotransmission in the limbic system. Neuroimage Clin. 2019;23:101905. doi: 10.1016/j.nicl.2019.101905. Epub 2019 Jun 18.
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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.
Alexandre DaSilva, DDS, MS principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pet Scan, MRI scan and Quantitative Sensory Testing (QST) in people with Migraine, run by University of Michigan 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 2 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: finished, as of the sponsor's last update on 24 Nov 2017. 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.
What does the primary outcome measure?
Level of mu-opioid receptor binding potential in the brain of episodic migraineurs during and outside the headache attack and compared to healthy controls. (time frame: 90 min PET scan). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03004313, which also lists 1 linked publication.
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 24 Nov 2017.