Brain Imaging and Pain: Analysis of Placebo Analgesia
|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.|
|ClinicalTrials.gov Identifier: NCT01409538|
Recruitment Status : Completed
First Posted : August 4, 2011
Last Update Posted : March 20, 2015
|Condition or disease||Intervention/treatment||Phase|
|Brain Imaging of Placebo Analgesia||Other: Placebo Instructions Other: Control condition||Phase 1|
This study is a basic science study of the mechanisms of placebo analgesia in asymptomatic healthy individuals. Each participant receives a baseline pain testing session, followed by a conditioning paradigm that results in expectation of pain relief and conditioning. They then undergo functional magnetic resonance imaging during either placebo (conditioned analgesia) or baseline. To examine order effects and habituation, the participants also either undergo a repeated placebo or a repeated baseline. The primary dependent measures in the study are the fMRI determined regions of interest, in a network of brain areas associated with pain processing. The anticipated outcome of the study is the alteration of network connectivity between sensory, affective, evaluative areas of the brain associated with placebo.
Because this is not a traditional clinical trial, there are not traditional efficacy criteria, rather the outcomes are changes in brain function from manipulations of patient expectation and classical conditioning.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Basic Science|
|Official Title:||Brain Imaging and Pain: Analysis of Placebo Analgesia|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||January 2015|
Placebo Comparator: Placebo
Asymptomatic control participants receive Natural History and Placebo instructions in a within-subject design. There are no patients, or active agents in this study. It is not a Clinical Trial.
Other: Placebo Instructions
There is no intervention in this study. It is not a Clinical Trial. The study is an investigation of the neural basis of placebo analgesia.
Active Comparator: Control condition
The control condition represents a no-intervention, repeated baseline control, since the "active" intervention in this study is placebo.
Other: Control condition
This protocol represents an investigation of the neural mechanisms of placebo analgesia. As such, it does not represent the traditional clinical trial design. Instead the "active" intervention is a placebo, and the comparison condition is a no-intervention control.
- Brain Imaging Results [ Time Frame: 2 weeks from baseline ]This outcomes represents the neural network underpinnings of the placebo analgesic response. It is the result of a network analysis using structural equation modeling of fMRI determined brain activations.
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 ClinicalTrials.gov identifier (NCT number): NCT01409538
|United States, Florida|
|University of Florida|
|Gainesville, Florida, United States, 32611|
|Principal Investigator:||Michael E Robinson, Ph.D.||University of Florida|