Treatment Of Chronic Pain Using Real Time fMRI

April 25, 2011 updated by: Omneuron

Treatment Of Chronic Pain Using Real-time Functional MRI Trial

The purpose of this study is to test a new investigational method for treatment of chronic pain using cognitive training guided by functional magnetic resonance imaging (fMRI).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Chronic pain is a substantial medical and economic problem, and is often unresponsive to conventional treatment. In this study, scientists will seek to decrease pain by increasing control over pain using newly-developed brain imaging methods to train people to control their own brain activation. This is the first clinical application of a recently-developed technology allowing a person to watch their own brain activation second-by-second and to learn to control it. It may provide a means to train people to control chronic pain by controlling their own brain states.

The purpose of the study is to evaluate real-time functional magnetic resonance imaging (fMRI) feedback for treating chronic pain diagnoses, including fibromyalgia, neuralgia, neuropathy, migraine, and complex regional pain syndrome (CRPS)/reflex sympathetic dystrophy (RSD). The study will also measure the impact of cognitive training for pain control on activations from the areas of the brain involved in pain.

All participants in this study will receive a new form of cognitive training for controlling pain. Participants will be scanned using fMRI while they employ the cognitive training strategies-allowing them to view their brain activity. Some participants will see their own brain activation during this process while other participants will see very similar but simulated data that does not come from their own brains.

Participation in the study will last about 6 months with 12 visits that includes 6 sessions in an MRI scanner. Recruitment for this trial is limited to persons in the San Francisco Bay area. Participants must be able to attend sessions in Menlo Park, CA. Participants will be reimbursed for travel time within the Bay area.

Information gained from this study may help in developing potential future treatments for chronic pain.

Study Type

Interventional

Enrollment (Anticipated)

144

Phase

  • Phase 2

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
      • Menlo Park, California, United States, 94025
        • Omneuron, 99 El Camino Real

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

21 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinically diagnosed chronic pain. Some example diagnoses include: CRPS, RSD, neuropathy, neuralgia, fibromyalgia, or migraine.
  • No implanted medical devices that are not compatible with MRI (spinal cord stimulator/pump, pacemaker, surgical aneurysm clip, etc)
  • No recent history of severe psychiatric illness
  • Weight less than 220 lbs.
  • Able to be scanned in MRI without claustrophobia
  • No facial tattoos, non-removable metal implants, piercings, or extensive dental work.
  • Not pregnant or having fertility treatments

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Participants will see their own brain activation.
Behavioral: cognitive training using fMRI
Participants will be scanned using fMRI while they employ the cognitive training strategies-allowing them to view their brain activity.
Placebo Comparator: 2
Participants will see simulated data that does not come from their own brains.
Behavioral: placebo
Some participants will see simulated data that does not come from their own brains.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measures of Pain Magnitude; McGill Pain Questionnaire; Visual Analogue Scale; Coping Strategies; Pain Catastrophizing Scale; Beck Depression Inventory; Treatment Outcome of Pain States; Increased control over brain activation measured using fMRI
Time Frame: duration of the trial
duration of the trial

Collaborators and Investigators

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

Sponsor

Omneuron

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

  • Principal Investigator: Christopher deCharms, PhD, Omneuron

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

September 1, 2007

Primary Completion (Anticipated)

August 1, 2011

Study Completion (Anticipated)

August 1, 2011

Study Registration Dates

First Submitted

September 11, 2007

First Submitted That Met QC Criteria

September 11, 2007

First Posted (Estimate)

September 12, 2007

Study Record Updates

Last Update Posted (Estimate)

April 26, 2011

Last Update Submitted That Met QC Criteria

April 25, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2R44NS050642-06 (U.S. NIH Grant/Contract)

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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