search
Back to results

Treatment Of Chronic Pain Using Real Time fMRI

Primary Purpose

Chronic Pain

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
cognitive training using fMRI
placebo
Sponsored by
Omneuron
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring chronic pain, functional magnetic resonance imaging, fMRI, cognitive training

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Omneuron, 99 El Camino Real

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Participants will see their own brain activation.

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

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
September 11, 2007
Last Updated
April 25, 2011
Sponsor
Omneuron
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
search

1. Study Identification

Unique Protocol Identification Number
NCT00528346
Brief Title
Treatment Of Chronic Pain Using Real Time fMRI
Official Title
Treatment Of Chronic Pain Using Real-time Functional MRI Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Unknown status
Study Start Date
September 2007 (undefined)
Primary Completion Date
August 2011 (Anticipated)
Study Completion Date
August 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Omneuron
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
chronic pain, functional magnetic resonance imaging, fMRI, cognitive training

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Participants will see their own brain activation.
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Participants will see simulated data that does not come from their own brains.
Intervention Type
Behavioral
Intervention Name(s)
cognitive training using fMRI
Intervention Description
Participants will be scanned using fMRI while they employ the cognitive training strategies-allowing them to view their brain activity.
Intervention Type
Behavioral
Intervention Name(s)
placebo
Intervention Description
Some participants will see simulated data that does not come from their own brains.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher deCharms, PhD
Organizational Affiliation
Omneuron
Official's Role
Principal Investigator
Facility Information:
Facility Name
Omneuron, 99 El Camino Real
City
Menlo Park
State/Province
California
ZIP/Postal Code
94025
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Treatment Of Chronic Pain Using Real Time fMRI

We'll reach out to this number within 24 hrs