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Clinical Trials/NCT01409538
NCT01409538
Completed
Phase 1

Brain Imaging and Pain: Analysis of Placebo Analgesia

University of Florida1 site in 1 country140 target enrollmentJanuary 2010

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Brain Imaging of Placebo Analgesia
Sponsor
University of Florida
Enrollment
140
Locations
1
Primary Endpoint
Brain Imaging Results
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

This study examines the brain activation associated with placebo pain reduction.

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.

Registry
clinicaltrials.gov
Start Date
January 2010
End Date
January 2015
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • at least 18 years of age
  • english speaking

Exclusion Criteria

  • pain condition

Outcomes

Primary Outcomes

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.

Study Sites (1)

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