Treatment Of Chronic Pain Using Real Time fMRI
|ClinicalTrials.gov Identifier: NCT00528346|
Recruitment Status : Unknown
Verified April 2011 by Omneuron.
Recruitment status was: Active, not recruiting
First Posted : September 12, 2007
Last Update Posted : April 26, 2011
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain||Behavioral: cognitive training using fMRI Behavioral: placebo||Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||144 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Treatment Of Chronic Pain Using Real-time Functional MRI Trial|
|Study Start Date :||September 2007|
|Estimated Primary Completion Date :||August 2011|
|Estimated Study Completion Date :||August 2011|
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.
Some participants will see simulated data that does not come from their own brains.
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00528346
|United States, California|
|Omneuron, 99 El Camino Real|
|Menlo Park, California, United States, 94025|
|Principal Investigator:||Christopher deCharms, PhD||Omneuron|