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Sponsors and Collaborators: |
Omneuron National Institute of Neurological Disorders and Stroke (NINDS) |
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Information provided by: | National Institute of Neurological Disorders and Stroke (NINDS) |
ClinicalTrials.gov Identifier: | NCT00528346 |
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).
Condition | Intervention | Phase |
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Chronic Pain |
Behavioral: cognitive training using fMRI Behavioral: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Treatment Of Chronic Pain Using Real-Time Functional MRI Trial |
Estimated Enrollment: | 144 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | August 2010 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Participants will see their own brain activation.
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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.
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2: Placebo Comparator
Participants will see simulated data that does not come from their own brains.
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Behavioral: placebo
Some participants will see simulated data that does not come from their own brains.
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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 and includes 7 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.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contact: Ella Laramee | 650-585-5304 | research@omneuron.com |
United States, California | |
Omneuron, 99 El Camino Real | Recruiting |
Menlo Park, California, United States, 94025 | |
Contact: Ella Laramee 650-585-5304 research@omneuron.com | |
Principal Investigator: Christopher deCharms, PhD |
Principal Investigator: | Christopher deCharms, PhD | Omneuron |
Responsible Party: | Omneuron ( Christopher deCharms, Principal Investigator ) |
Study ID Numbers: | 2R44NS050642-06 |
Study First Received: | September 11, 2007 |
Last Updated: | June 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00528346 |
Health Authority: | United States: Federal Government |
chronic pain functional magnetic resonance imaging fMRI cognitive training |
Signs and Symptoms Neurologic Manifestations Pain |
Nervous System Diseases |