Molecular and Functional PET-fMRI Measures of Analgesia in Migraine
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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
|Official Title:||Molecular and Functional PET-fMRI Measures of Analgesia in Migraine|
- VAS Pain rating [ Time Frame: 1 day ] [ Designated as safety issue: No ]This study will investigate how placebo may reduce experimental pain induced by contact heat.
- fMRI BOLD signal [ Time Frame: 1 day ] [ Designated as safety issue: No ]Functional Magnetic Resonance Imaging Blood Oxygenation Level Dependent Signal will be obtained.
- PET Diprenorphine [ Time Frame: 1 day ] [ Designated as safety issue: No ]Positron Emission Tomography with C11 diprenorphine will be used to measure opioid receptors
|Study Start Date:||March 2013|
|Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
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.
Placebo will be compared to No Intervention.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01970943
|United States, Massachusetts|
|Athinoula A. Martinos. Center for Biomedical Imaging|
|Charlestown, Massachusetts, United States, 02129|
|Principal Investigator:||David Borsook, MD, Ph.D||Children's Hospital Boston|