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Brain Imaging and Pain: Analysis of Placebo Analgesia

Brain Imaging and Pain: Analysis of Placebo Analgesia

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01409538
Enrollment
140
Registered
2011-08-04
Start date
2010-01-31
Completion date
2015-01-31
Last updated
2015-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Imaging of Placebo Analgesia

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.

Interventions

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.

OTHERControl 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.

Sponsors

University of Florida
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* at least 18 years of age * english speaking

Exclusion criteria

* pain condition * pregnant

Design outcomes

Primary

MeasureTime frameDescription
Brain Imaging Results2 weeks from baselineThis 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026