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Molecular and Functional PET-fMRI Measures of Analgesia in Migraine

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Mass General Brigham

Status

Completed

Conditions

Healthy
Migraine

Treatments

Other: Placebo

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01970943
AT007530-01
R21AT007530-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

23 patients

Sex

All

Ages

21 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

23 participants in 2 patient groups, including a placebo group

No Intervention
No Intervention group
Description:
PET-fMRI investigation on healthy subjects and patients with migraine. No drug condition.
Saline Injection (Placebo)
Placebo Comparator group
Description:
PET-fMRI investigation on healthy subjects and patients with migraine. Placebo condition.
Treatment:
Other: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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