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Treatment Of Chronic Pain Using Real Time fMRI

O

Omneuron

Status and phase

Unknown
Phase 2

Conditions

Chronic Pain

Treatments

Behavioral: placebo
Behavioral: cognitive training using fMRI

Study type

Interventional

Funder types

Industry
NIH

Identifiers

NCT00528346
2R44NS050642-06

Details and patient eligibility

About

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).

Full 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.

Enrollment

144 estimated patients

Sex

All

Ages

21 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

144 participants in 2 patient groups, including a placebo group

1
Active Comparator group
Description:
Participants will see their own brain activation.
Treatment:
Behavioral: cognitive training using fMRI
2
Placebo Comparator group
Description:
Participants will see simulated data that does not come from their own brains.
Treatment:
Behavioral: placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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