Chronic Pain Treatment Using Real Time Functional Magnetic Resonance Imaging (fMRI)

Who May Be a Candidate

Male and female patients with chronic pain, in the San Francisco Bay area, ages 21-60 years may participate in this study if inclusion criteria are met.

Study participation will be for about 6 months and candidates must be available to attend 12 sessions in Menlo Park, California. Ten (10) visits occur over a 10-week span with follow-up visits at 2 months and 6 months.

The clinical trial sponsor and collaborator do not imply that participation in this study will lead to a participant's decrease in pain.

Treatment Being Studied

Omneuron, Inc., a clinical trial research company, is studying a means to decrease pain by increasing control over pain using newly-developed brain imaging methods to train chronic pain patients to control their own brain activation. This is the first clinical application of functional Magnetic Resonance Imaging (fMRI) allowing patients to watch their own brain activation in real time to learn how to control it. The results of this study may provide a means to train chronic pain patients how to control their pain.

Study participants will receive a new form of cognitive training to control pain. Participants will be scanned using real time fMRI feedback while they employ the cognitive training strategies.

Study participation is anticipated to last about 6 months and includes 6 sessions in an MRI scanner. Participants must be able to attend 12 sessions in Menlo Park, California.

Participants will receive cash compensation for time spent in the scanner, traveling to study appointments (within the San Francisco Bay area) and completing questionnaires. Participants will receive $25.00 (US) per hour for the fMRI portions of the study and $10.00 (US) per hour for study-related travel and activities.

Clinical Trial Sponsor and Collaborator

The Principal Investigator on this research study is Christopher deCharms, PhD. This study is sponsored by Omneuron, Inc. and receives funding from the National Institute of Neurological Disorders and Stroke (NINDS).

Official Website: http://www.chronicpainresearchstudy.com/

E-mail: research@omneuron

Purpose and Objective

The results of this study may provide a means to train chronic pain patients how to control their pain. This is the first clinical application of Functional Magnetic Resonance Imaging (fMRI) allowing patients to watch their own brain activation in real time to learn how to control it.

Study participants will receive a new form of cognitive training to control pain. Participants will be scanned using real time fMRI feeback while they employ the cognitive training strategies.

Recruiting Location (United States)

Menlo Park, California
To find out if you are eligible, please visit the site and complete the
screening at www.chronicpainresearchstudy.com/
For study-related questions: Ella Laramee at research@omneuron
Principal Investigator: Christopher deCharms, PhD

Eligibility, Inclusion and Exclusion Criteria

1. Clinically diagnosed chronic pain such as Complex Regional Pain Syndrome (CRPS), Reflex Sympathetic Dystrophy (RSD), neuropathy, neuralgia, fibromyalgia, or migraine for greater than 6 months.

2. No implanted medical devices that are not compatible with MRI, such as spinal cord stimulator / pump, pacemaker, surgical aneurysm clip, others.

3. No recent history of severe psychiatric illness

4. Weight less than 220 pounds

5. Able to be scanned using MRI without claustrophobia

6. No facial tattoos, non-removable metal implants, piercings, or extensive dental work.

7. Not pregnant or undergoing fertility treatment

E-mail: research@omneuron

ClinicalTrials.gov Identifier: NCT00528346

Study ID Numbers: 2R44NS050642-06

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

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