Real-Time fMRI Feedback Effects on Pain Perception

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01588197
First received: February 10, 2012
Last updated: May 3, 2016
Last verified: May 2016
  Purpose
The purpose of this study is to determine whether real-time functional magnetic resonance imaging may be a viable treatment for chronic pain in the future.

Condition Intervention
Cognitive Pain Control
Behavioral: MRI Feedback

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Real-Time fMRI Feedback Effects on Pain Perception

Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • RT-fMRI enhancement of the effects of cognitive pain control strategies [ Time Frame: Participants will be monitored for the duration of the study visit, with an expected average of 2 hours. ] [ Designated as safety issue: No ]
    Activation of Prefrontal Cortex and rACC from fMRI images


Secondary Outcome Measures:
  • Effectiveness of cognitive pain modulation techniques [ Time Frame: Participants will be monitored for the duration of the study visit, with an expected average of 2 hours. ] [ Designated as safety issue: No ]
    subjective verbal pain ratings and thermal pain thresholds


Estimated Enrollment: 30
Study Start Date: November 2010
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PreFrontal Cortex Behavioral: MRI Feedback
Real Time fMRI Feedback
Experimental: Anterior Cingulate Behavioral: MRI Feedback
Real Time fMRI Feedback

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adults ages 18-65

Exclusion Criteria:

  • Clinical depression
  • Anxiety
  • Substance dependence or chronic pain
  • Ferrous metal implants
  • Cardiac pacemakers or other implanted medical devices that might be adversely impacted by the MRI scanner magnetic field
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01588197

Locations
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Jeffery J Borckardt, PhD Medical University of South Carolina
  More Information

Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01588197     History of Changes
Other Study ID Numbers: HR # 20270 
Study First Received: February 10, 2012
Last Updated: May 3, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:
Pain
fMRI
real time

ClinicalTrials.gov processed this record on August 28, 2016