Molecular and Functional PET-fMRI Measures of Analgesia in Migraine

NCT ID: NCT01970943

Last Updated: 2019-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-01
• Study Completion Date: 2017-10-30

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.

Conditions

Migraine; Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

No Intervention

PET-fMRI investigation on healthy subjects and patients with migraine. No drug condition.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Saline Injection (Placebo)

PET-fMRI investigation on healthy subjects and patients with migraine. Placebo condition.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo will be compared to No Intervention.

Interventions

Placebo

Placebo will be compared to No Intervention.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

David Borsook

David Borosook, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Borsook, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

Athinoula A. Martinos. Center for Biomedical Imaging

Charlestown, Massachusetts, United States

Countries

United States

Other Identifiers

R21AT007530-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AT007530-01

Identifier Type: -

Identifier Source: org_study_id