Treatment Of Chronic Pain Using Real Time fMRI - Full Text View

Sponsor:	Omneuron
Collaborator:	National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by:	Omneuron
ClinicalTrials.gov Identifier:	NCT00528346

Purpose

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
Chronic Pain	Behavioral: cognitive training using fMRI Behavioral: placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Treatment Of Chronic Pain Using Real-time Functional MRI Trial

Resource links provided by NLM:

MedlinePlus related topics: Chronic Pain MRI Scans

U.S. FDA Resources

Further study details as provided by Omneuron:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	144
Study Start Date:	September 2007
Estimated Study Completion Date:	August 2011
Estimated Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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.

Eligibility

Ages Eligible for Study:	21 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00528346

Locations

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

Sponsors and Collaborators

Omneuron

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

Principal Investigator:

Christopher deCharms, PhD

Omneuron

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Christopher deCharms, Principal Investigator, Omneuron
ClinicalTrials.gov Identifier:	NCT00528346 History of Changes
Other Study ID Numbers:	2R44NS050642-06
Study First Received:	September 11, 2007
Last Updated:	April 25, 2011
Health Authority:	United States: Federal Government

Keywords provided by Omneuron:

chronic pain
functional magnetic resonance imaging
fMRI
cognitive training

ClinicalTrials.gov processed this record on May 22, 2012