NCT02987933

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.

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
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2016

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

November 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 7, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 9, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

December 9, 2016

Status Verified

December 1, 2016

Enrollment Period

1 year

First QC Date

December 7, 2016

Last Update Submit

December 8, 2016

Conditions

Keywords

Chronic PainfMRIDTI

Outcome Measures

Primary Outcomes (1)

  • Functional brain connectivity

    Assessed by fMRI

    6 months

Study Arms (2)

Chronic Pain

Adults, \> 6 months duration, daily pain

Healthy Normals

Age and gender matched controls

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with daily chronic pain (\> 6 months)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

WNY MRI

Buffalo, New York, 14203, United States

RECRUITING

Related Publications (5)

  • 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.

    PMID: 20506181BACKGROUND
  • 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.

    PMID: 24623774BACKGROUND
  • 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.

    PMID: 18256259BACKGROUND
  • 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.

    PMID: 27182487BACKGROUND
  • 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.

    PMID: 20800649BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • David S Wack, Ph.D.

    University at Buffalo: SUNY

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David S Wack, Ph.D.

CONTACT

David T Corey, Ph.D.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2016

First Posted

December 9, 2016

Study Start

November 1, 2016

Primary Completion

November 1, 2017

Study Completion

January 1, 2018

Last Updated

December 9, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations