Overview

This trial is active, not recruiting.

Condition chronic pain
Treatments cognitive training using fmri, placebo
Phase phase 2
Sponsor Omneuron
Collaborator National Institute of Neurological Disorders and Stroke (NINDS)
Start date September 2007
End date August 2011
Trial size 144 participants
Trial identifier NCT00528346, 2R44NS050642-06

Summary

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Active Comparator)
Participants will see their own brain activation.
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)
Participants will see simulated data that does not come from their own brains.
placebo
Some participants will see simulated data that does not come from their own brains.

Primary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 21 years up to 60 years old.

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

Additional Information

Official title Treatment Of Chronic Pain Using Real-time Functional MRI Trial
Principal investigator Christopher deCharms, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2011.
Information provided to ClinicalTrials.gov by Omneuron.