Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
144 participants
INTERVENTIONAL
2007-09-30
2011-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
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.
2
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.
Interventions
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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
Some participants will see simulated data that does not come from their own brains.
Eligibility Criteria
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Inclusion Criteria
* 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
21 Years
60 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Omneuron
INDUSTRY
Responsible Party
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Omneuron
Principal Investigators
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Christopher deCharms, PhD
Role: PRINCIPAL_INVESTIGATOR
Omneuron
Locations
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Omneuron, 99 El Camino Real
Menlo Park, California, United States
Countries
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Other Identifiers
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