MedDataX Logo

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

NCT ID: NCT02987933

Last Updated: 2016-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-30

Study Completion Date

2018-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Pain

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Chronic Pain fMRI DTI

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Chronic Pain

Adults, \> 6 months duration, daily pain

No interventions assigned to this group

Healthy Normals

Age and gender matched controls

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

State University of New York at Buffalo

OTHER

Sponsor Role collaborator

Brain Scan Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David S Wack, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University at Buffalo: SUNY

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

WNY MRI

Buffalo, New York, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

David S Wack, Ph.D.

Role: CONTACT

Phone: 716-838-5889

Email: [email protected]

David T Corey, Ph.D.

Role: CONTACT

Phone: 855-822-7226

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

David S Wack, Ph.D.

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 20506181 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24623774 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18256259 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27182487 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20800649 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BSI001

Identifier Type: -

Identifier Source: org_study_id