Treatment Of Chronic Pain Using Real Time fMRI

NCT ID: NCT00528346

Last Updated: 2011-04-26

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2011-08-31

Brief Summary

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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).

Detailed Description

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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 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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Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Participants will see their own brain activation.

Group Type ACTIVE_COMPARATOR

cognitive training using fMRI

Intervention Type BEHAVIORAL

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.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

placebo

Some participants will see simulated data that does not come from their own brains.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

Omneuron

INDUSTRY

Sponsor Role lead

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

Site Status

Countries

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United States

Other Identifiers

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2R44NS050642-06

Identifier Type: NIH

Identifier Source: org_study_id

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