ClinicalTrials.gov
ClinicalTrials.gov Menu

Applications of Realtime Functional Magnetic Resonance Imaging (fMRI )

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01111617
Recruitment Status : Active, not recruiting
First Posted : April 27, 2010
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Sean Mackey, Stanford University

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

Condition or disease Intervention/treatment Phase
Pain Procedure: Real-time fMRI feedback Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Applications of Realtime fMRI Phase II
Study Start Date : January 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: Real-Time fMRI
Real-Time fMRI
Procedure: Real-time fMRI feedback
Patients receive real-time fMRI biofeedback to modulate pain




Primary Outcome Measures :
  1. Pain reduction as measured by visual analog scale (VAS) pain report [ Time Frame: Within the 2 hour feedback session ]

Secondary Outcome Measures :
  1. Control of brain activity as measured by fMRI analysis [ Time Frame: Within the 2 hour feedback session ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01111617


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Sean Mackey Stanford University

Responsible Party: Sean Mackey, Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT01111617     History of Changes
Other Study ID Numbers: SU-11062007-809
95194
First Posted: April 27, 2010    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018