Molecular and Functional PET-fMRI Measures of Analgesia in Migraine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01970943
Recruitment Status : Unknown
Verified January 2015 by David Borsook, Mclean Hospital.
Recruitment status was:  Active, not recruiting
First Posted : October 28, 2013
Last Update Posted : January 30, 2015
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
David Borsook, Mclean Hospital

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.

Condition or disease Intervention/treatment Phase
Migraine Healthy Other: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Molecular and Functional PET-fMRI Measures of Analgesia in Migraine
Study Start Date : March 2013
Actual Primary Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
No Intervention: No Intervention
PET-fMRI investigation on healthy subjects and patients with migraine. No drug condition.
Placebo Comparator: Saline Injection (Placebo)
PET-fMRI investigation on healthy subjects and patients with migraine. Placebo condition.
Other: Placebo
Placebo will be compared to No Intervention.

Primary Outcome Measures :
  1. VAS Pain rating [ Time Frame: 1 day ]
    This study will investigate how placebo may reduce experimental pain induced by contact heat.

Secondary Outcome Measures :
  1. fMRI BOLD signal [ Time Frame: 1 day ]
    Functional Magnetic Resonance Imaging Blood Oxygenation Level Dependent Signal will be obtained.

  2. PET Diprenorphine [ Time Frame: 1 day ]
    Positron Emission Tomography with C11 diprenorphine will be used to measure opioid receptors

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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01970943

United States, Massachusetts
Athinoula A. Martinos. Center for Biomedical Imaging
Charlestown, Massachusetts, United States, 02129
Sponsors and Collaborators
Massachusetts General Hospital
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: David Borsook, MD, Ph.D Boston Children’s Hospital

Responsible Party: David Borsook, David Borosook, MD, Mclean Hospital Identifier: NCT01970943     History of Changes
Other Study ID Numbers: AT007530-01
R21AT007530-01 ( U.S. NIH Grant/Contract )
First Posted: October 28, 2013    Key Record Dates
Last Update Posted: January 30, 2015
Last Verified: January 2015

Keywords provided by David Borsook, Mclean Hospital:
migraine, headache, episodic, chronic, pain

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases