The Use of Resting State, fMRI and DTI in the Identification of Chronic Pain Conditions

December 8, 2016 updated by: Brain Scan Inc.
Resting state fMRI scans of chronic pain sufferers will be compared to those of healthy normals and may be sufficiently different to allow a high level of classification accuracy of whether subjects have chronic pain. In addition, investigators will utilize DTI and a brief activation state using pain rumination to assess whether investigators can reliably find differences between chronic pain sufferers and healthy normals.

Study Overview

Status

Unknown

Conditions

Detailed Description

Resting state fMRI scans of chronic pain sufferers may be sufficiently different from scans of normal subjects to allow a high level of classification accuracy of whether subjects have chronic pain. In addition, investigators will utilize DTI and a brief activation state using pain rumination to assess whether investigators can reliably find differences between chronic pain sufferers and healthy normals. The analysis will use pattern recognition methods in a leave N out cross validation design. The success of the classifications will be the mean of all the validation runs.

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14203
        • Recruiting
        • WNY MRI
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults with daily chronic pain (> 6 months)

Description

Inclusion Criteria:

Daily Pain lasting for more than 6 months. Ages eligible for study are between 20 and 70 years.

Exclusion Criteria:

Adults unable to consent Children, teenagers Pregnant women Prisoners Subjects who do not know English MRI exclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Chronic Pain
Adults, > 6 months duration, daily pain
Healthy Normals
Age and gender matched controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional brain connectivity
Time Frame: 6 months
Assessed by fMRI
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brain Scan Inc.

Collaborators

State University of New York at Buffalo

Investigators

  • Principal Investigator: David S Wack, Ph.D., University at Buffalo: SUNY

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (ANTICIPATED)

November 1, 2017

Study Completion (ANTICIPATED)

January 1, 2018

Study Registration Dates

First Submitted

December 7, 2016

First Submitted That Met QC Criteria

December 8, 2016

First Posted (ESTIMATE)

December 9, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

December 9, 2016

Last Update Submitted That Met QC Criteria

December 8, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BSI001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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