NCT00528346

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
144

participants targeted

Target at P50-P75 for phase_2 chronic-pain

Timeline
Completed

Started Sep 2007

Typical duration for phase_2 chronic-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 12, 2007

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

April 26, 2011

Status Verified

April 1, 2011

Enrollment Period

3.9 years

First QC Date

September 11, 2007

Last Update Submit

April 25, 2011

Conditions

Chronic Pain

Keywords

chronic painfunctional magnetic resonance imagingfMRIcognitive training

Outcome Measures

Primary Outcomes (1)

  • 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

    duration of the trial

Study Arms (2)

1

ACTIVE COMPARATOR

Participants will see their own brain activation.

Behavioral: cognitive training using fMRI

2

PLACEBO COMPARATOR

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

Behavioral: placebo

Interventions

cognitive training using fMRIBEHAVIORAL

Participants will be scanned using fMRI while they employ the cognitive training strategies-allowing them to view their brain activity.

1
placeboBEHAVIORAL

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

2

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Omneuron, 99 El Camino Real

Menlo Park, California, 94025, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Christopher deCharms, PhD

    Omneuron

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 11, 2007

First Posted

September 12, 2007

Study Start

September 1, 2007

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

April 26, 2011

Record last verified: 2011-04

Locations

US(1)