Clinical trial NCT02987933: The Use of Resting State, fMRI and DTI in the Identification of Chronic Pain Conditions
Official title: The Use of Resting State, fMRI and DTI in the Identification of Chronic Pain Conditions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Pain
Keywords: Chronic Pain
fMRI
DTI
Lead sponsor: Brain Scan Inc.
Sponsor class: INDUSTRY
Collaborators: name: State University of New York at Buffalo
First posted: 2016-12-09
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with daily chronic pain (\> 6 months)

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional brain connectivity
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: WNY MRI
state: New York
Study officials:
affiliation: University at Buffalo: SUNY
name: David S Wack, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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;11:606-613. doi: 10.1016/j.nicl.2016.04.001. eCollection 2016.
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. Epub 2010 Aug 26.