Applications of Realtime Functional Magnetic Resonance Imaging (fMRI )

March 21, 2024 updated by: Sean Mackey, Stanford University

Applications of Realtime fMRI Phase II

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain reduction as measured by visual analog scale (VAS) pain report
Time Frame: Within the 2 hour feedback session
Within the 2 hour feedback session

Secondary Outcome Measures

Outcome Measure
Time Frame
Control of brain activity as measured by fMRI analysis
Time Frame: Within the 2 hour feedback session
Within the 2 hour feedback session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Sean Mackey, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

November 1, 2023

Study Completion (Actual)

November 1, 2023

Study Registration Dates

First Submitted

January 29, 2010

First Submitted That Met QC Criteria

April 26, 2010

First Posted (Estimated)

April 27, 2010

Study Record Updates

Last Update Posted (Actual)

March 25, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • SU-11062007-809
  • 95194

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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