Brain Imaging and Pain: Analysis of Placebo Analgesia
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Purpose
This study examines the brain activation associated with placebo pain reduction.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain Imaging of Placebo Analgesia |
Other: Placebo Instructions Other: Control condition |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Basic Science |
| Official Title: | Brain Imaging and Pain: Analysis of Placebo Analgesia |
- Brain Imaging Results [ Time Frame: 2 weeks from baseline ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
Other Name: Control condition
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- at least 18 years of age
- english speaking
Exclusion Criteria:
- pain condition
- pregnant
Contacts and Locations| United States, Florida | |
| University of Florida | |
| Gainesville, Florida, United States, 32611 | |
| Principal Investigator: | Michael E Robinson, Ph.D. | University of Florida |
More Information
No publications provided
| Responsible Party: | University of Florida |
| ClinicalTrials.gov Identifier: | NCT01409538 History of Changes |
| Other Study ID Numbers: | R01 AT001424-05A |
| Study First Received: | August 2, 2011 |
| Last Updated: | September 27, 2012 |
| Health Authority: | USA: University of Florida Institutional Review Board |
ClinicalTrials.gov processed this record on May 22, 2013