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NCT02987933 Clinical Trial

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

Chronic Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02987933
Other study ID # BSI001
Secondary ID
Status Recruiting
Phase N/A
First received December 7, 2016
Last updated December 8, 2016
Start date November 2016
Est. completion date January 2018

Study information
Verified date December 2016
Source Brain Scan Inc.
Contact David S Wack, Ph.D.
Phone 716-838-5889
Email dswack@buffalo.edu
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date January 2018
Est. primary completion date November 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 70 Years
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States WNY MRI Buffalo New York

Sponsors (2)
Lead Sponsor Collaborator
Brain Scan Inc. State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

References & Publications (5)

Baliki MN, Geha PY, Apkarian AV, Chialvo DR. Beyond feeling: chronic pain hurts the brain, disrupting the default-mode network dynamics. J Neurosci. 2008 Feb 6;28(6):1398-403. doi: 10.1523/JNEUROSCI.4123-07.2008. — View Citation

Boeckle M, Schrimpf M, Liegl G, Pieh C. Neural correlates of somatoform disorders from a meta-analytic perspective on neuroimaging studies. Neuroimage Clin. 2016 Apr 10;11:606-13. doi: 10.1016/j.nicl.2016.04.001. — View Citation

Kucyi A, Moayedi M, Weissman-Fogel I, Goldberg MB, Freeman BV, Tenenbaum HC, Davis KD. Enhanced medial prefrontal-default mode network functional connectivity in chronic pain and its association with pain rumination. J Neurosci. 2014 Mar 12;34(11):3969-75. doi: 10.1523/JNEUROSCI.5055-13.2014. — View Citation

Napadow V, LaCount L, Park K, As-Sanie S, Clauw DJ, Harris RE. Intrinsic brain connectivity in fibromyalgia is associated with chronic pain intensity. Arthritis Rheum. 2010 Aug;62(8):2545-55. doi: 10.1002/art.27497. — View Citation

Tagliazucchi E, Balenzuela P, Fraiman D, Chialvo DR. Brain resting state is disrupted in chronic back pain patients. Neurosci Lett. 2010 Nov 12;485(1):26-31. doi: 10.1016/j.neulet.2010.08.053. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Functional brain connectivity Assessed by fMRI 6 months No
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