Applications of Realtime Functional Magnetic Resonance Imaging (fMRI )

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2013 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Sean Mackey, Stanford University
ClinicalTrials.gov Identifier:
NCT01111617
First received: January 29, 2010
Last updated: May 14, 2013
Last verified: May 2013
  Purpose

The goal of this research program is to determine the potential effectiveness of real-time fMRI training in improving mental control over pain.


Condition Intervention
Pain
Procedure: Real-time fMRI feedback

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Applications of Realtime fMRI Phase II

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Pain reduction as measured by visual analog scale (VAS) pain report [ Time Frame: Within the 2 hour feedback session ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Control of brain activity as measured by fMRI analysis [ Time Frame: Within the 2 hour feedback session ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: January 2014
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Real-time fMRI feedback
    Patients receive real-time fMRI biofeedback to modulate pain
Detailed Description:

A research study that looks at pain and how you experience pain. This research project aims to use virtual reality-based real-time functional Magnetic Resonance Imaging (rtfMRI) to assess brain activation during the experience of pain and while subjects attempt to mentally control their pain response.

  Eligibility

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

Inclusion Criteria:

  • Age 18-65
  • Chronic Pain patient or healthy control
  • Ability to perform the experimental task

Exclusion Criteria:

  • MRI contraindication (metal implants, claustrophobia, pregnant or planning to become pregnant)
  • History of psychiatric disorder (at the discretion of the investigator as to whether it interferes with the experimental task)
  • History of Blistering
  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: NCT01111617

Contacts
Contact: Rebecca McCue snapl@stanford.edu

Locations
United States, California
Stanford University School of Medicine Not yet recruiting
Stanford, California, United States, 94305
Contact: Rebecca McCue       snapl@stanford.edu   
Principal Investigator: Sean Mackey         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Sean Mackey Stanford University
  More Information

No publications provided

Responsible Party: Sean Mackey, Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT01111617     History of Changes
Other Study ID Numbers: SU-11062007-809, 95194
Study First Received: January 29, 2010
Last Updated: May 14, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 30, 2014