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Molecular and Functional PET-fMRI Measures of Analgesia in Migraine

CompletedNot applicableNCT01970943
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Molecular and Functional PET-fMRI Measures of Analgesia in Migraine
Conditions
Interventions
Sponsor
Massachusetts General Hospital
Collaborators
National Institutes of Health (NIH); National Center for Complementary and Integrative Health (NCCIH)
Start date
2012-09-01
Primary completion
2014-04-30
Sex
All
Age range
from 21 Years to 50 Years
Healthy volunteers
true
Results posted
Yes, on ClinicalTrials.gov
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01970943