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Molecular and Functional PET-fMRI Measures of Analgesia in Migraine

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2015 by David Borsook, Mclean Hospital.
Recruitment status was:  Active, not recruiting
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
David Borsook, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT01970943
First received: May 23, 2013
Last updated: January 28, 2015
Last verified: January 2015
  Purpose
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 Intervention Phase
Migraine
Healthy
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Participant)
Primary Purpose: Basic Science
Official Title: Molecular and Functional PET-fMRI Measures of Analgesia in Migraine

Resource links provided by NLM:


Further study details as provided by David Borsook, Mclean Hospital:

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


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

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


Estimated Enrollment: 28
Study Start Date: March 2013
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01970943

Locations
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)
Investigators
Principal Investigator: David Borsook, MD, Ph.D Boston Children’s Hospital
  More Information

Responsible Party: David Borsook, David Borosook, MD, Mclean Hospital
ClinicalTrials.gov Identifier: NCT01970943     History of Changes
Other Study ID Numbers: AT007530-01
R21AT007530-01 ( US NIH Grant/Contract Award Number )
Study First Received: May 23, 2013
Last Updated: January 28, 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

ClinicalTrials.gov processed this record on May 25, 2017