Clinical trial NCT01970943: Molecular and Functional PET-fMRI Measures of Analgesia in Migraine
Official title: Molecular and Functional PET-fMRI Measures of Analgesia in Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Healthy
Keywords: migraine, headache, episodic, chronic, pain
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2013-10-28
Enrollment: 23
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The placebo effect is a phenomenon that has experienced major advances of its understanding in the last decade. However, mechanisms of placebo analgesia in chronic pain patients have yet to be compared to healthy subjects. The investigators study aims to investigate the magnitude of placebo response and related opioid release in patients that suffer from episodic migraines as compared to healthy controls. In particular, the investigators are looking to map brain activity during placebo analgesia using modern brain imaging techniques such as functional Magnetic Resonance Imaging (fMRI) and Positron Emission Tomography (PET). The investigators hypothesis is that placebo response and the availability of opioid receptors is reduced in chronic migraine patients.


Eligibility criteria: Inclusion Criteria:

* Migraine patients with aura with acute episodic migraine meeting the IHS Classification ICHD-II criteria, 3-14 migraines per month.
* History of episodic migraine for at least 3 years
* Ages 21-50
* Male or Female
* Right Handed

Matched healthy subjects will also be recruited.

Exclusion Criteria:

* Other significant disease (systemic or CNS)
* Pregnancy
* Claustrophobia
* Weight \>235 lbs (limit of MRI table)
* Significant drug including alcohol history (\> 7 glasses of alcohol per week)
* Beck Depression Inventory II (BDI-II) score \> 25 (moderate to severe depression)
* Any metal implants incompatible with MRI (including dental bridges, crowns, retainers, orthodontic devices e.g. braces, IUDs, aneurysm clips or other devices, tattoos containing metallic ink, cardiac pacemakers, prosthetic hear valves, other prostheses, neurostimulator devices, implanted infusion pumps, exposure to shrapnel or metal filings, cochlear implants, etc.)
* Previous significant research related exposure to ionizing radiation.
* History of allergy or adverse reaction to opioids
* Significant medical history of such as seizure disorder, diabetes, alcoholism, cardiac disease including coronary artery disease, psychiatric problems; drug addiction, respiratory problems, liver disease, etc.
* Positive drug of abuse screen (excluding medications currently prescribed for their clinical condition, e.g. opioids, benzodiazepines, etc.)
* Patients with migraine \<72 hours prior to the experiments will not be included to ensure inter-ictal state.
* Opioids or preventative medication such as topiramate, SSRIs etc.

Primary outcomes:
measure: Visual Analogue Scale (VAS) 0-10 Pain Rating
timeFrame: 1 day
Secondary outcomes:
measure: Pain Anticipation fMRI BOLD Signal
timeFrame: 1 day
measure: Pain Stimulation fMRI BOLD Signal
timeFrame: 1 day
measure: PET Diprenorphine
timeFrame: 1 day
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: Athinoula A. Martinos. Center for Biomedical Imaging
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: David Borsook, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: