Cognitive Flexibility Training for Persistent Pain: Neuroimaging Pilot (COFLEX-i)

NCT03720821 | Completed

• 1 other identifier: 201808143
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

To determine whether a 5-week computer-based cognitive training intervention results in changes in resting-state functional connectivity (rsFC) within the brain networks.

Conditions

Chronic Pain; Knee Pain Chronic; Hip Pain Chronic; Back Pain

Outcome Measures

Primary Outcomes (1)

• Changes in resting-state fMRI BOLD signal before and after 5 week cognitive training

  Changes in resting-state fMRI BOLD (blood oxygenation level dependent) signal before and after 5-week cognitive training, within the default mode, frontoparietal, and cingulo-opercular brain networks.

  5 weeks

Secondary Outcomes (1)

• Association between change in resting-state fMRI BOLD signal and the change in NCPT following cognitive training.

  5 weeks

Study Arms (1)

Cognitive Training + fMRI

EXPERIMENTAL

Participants will complete Trail Making Test (TMT) A \& B (both electronic and paper-pencil), the paper-pencil Color-Word Matching Stroop Test (CWMST), and its electronic version called "Color Match", and a computer-based subset of NCPT (Neurocognitive Performance Test). In addition, participants will also complete Brief Pain Inventory (BPI), Hospital Anxiety and Depression Scale (HADS), Pain Catastrophizing Scale (PCS), and the Resilience Scale questionnaires at baseline. Participants will be provided with the cognitive training module and participants will be required to complete a targeted 36-minute daily training for 35 days. Participants will be asked to undergo 2 functional magnetic resonance imaging (fMRI) sessions. One prior to, and one after the 5-week cognitive training period.

Behavioral: Cognitive Training + fMRI

Interventions

Cognitive Training + fMRI BEHAVIORAL

Consented subjects will be asked to participate in the study for up to five months. Patients will be consented at the Washington University Department of Anesthesiology and will be asked to complete baseline resilience, pain, and anxiety and depression questionnaires, along with cognitive tests by pencil and paper that will be administered by a member of the research team. The participants will also be required to complete a computer-based Trails-making test, Color Match test, and NCPT (Neurocognitive Performance Test) battery at baseline, and undergo a functional magnetic resonance imaging (fMRI) session. All subjects will be asked to complete the three paper-pencil and computer-based measurements along with repeat pain questionnaire again 1-3 days after completion of training, undergo a second fMRI scan at that time, and complete the questionnaires again 3 months after the completion of training.

Cognitive Training + fMRI

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults between 18 to 70 years old with chronic hip, knee or back pain for \>3 months
• Documented moderate to severe chronic pain
• English fluency
• Access to a computer at home and an email account

You may not qualify if:

• Lack of email/lack of basic computer skills
• Diagnosed Alzheimer's or documented severe cognitive impairment
• Severely impaired vision or color blindness
• Unable to complete cognitive testing
• An interventional pain procedure within one week prior to enrollment testing
• Scheduled to undergo a pain procedure during the five weeks of cognitive training
• Self-reported claustrophobia
• Contraindication to an MRI scan (i.e. presence of metallic foreign body such as an artificial joint or aneurism clip, implanted pacemaker or spinal cord stimulator)

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University in Saint Louis

St Louis, Missouri, 63110, United States

Location

Related Publications (27)

• Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X.

  PMID: 16698416 BACKGROUND

• Macrae WA. Chronic post-surgical pain: 10 years on. Br J Anaesth. 2008 Jul;101(1):77-86. doi: 10.1093/bja/aen099. Epub 2008 Apr 22.

  PMID: 18434337 BACKGROUND

• Haroutiunian S, Nikolajsen L, Finnerup NB, Jensen TS. The neuropathic component in persistent postsurgical pain: a systematic literature review. Pain. 2013 Jan;154(1):95-102. doi: 10.1016/j.pain.2012.09.010.

  PMID: 23273105 BACKGROUND

• Smith BH, Torrance N. Epidemiology of neuropathic pain and its impact on quality of life. Curr Pain Headache Rep. 2012 Jun;16(3):191-8. doi: 10.1007/s11916-012-0256-0.

  PMID: 22395856 BACKGROUND

• Dworkin RH, Panarites CJ, Armstrong EP, Malone DC, Pham SV. Healthcare utilization in people with postherpetic neuralgia and painful diabetic peripheral neuropathy. J Am Geriatr Soc. 2011 May;59(5):827-36. doi: 10.1111/j.1532-5415.2011.03403.x.

  PMID: 21568954 BACKGROUND

• Clarke H, Soneji N, Ko DT, Yun L, Wijeysundera DN. Rates and risk factors for prolonged opioid use after major surgery: population based cohort study. BMJ. 2014 Feb 11;348:g1251. doi: 10.1136/bmj.g1251.

  PMID: 24519537 BACKGROUND

• Apfelbaum JL, Chen C, Mehta SS, Gan TJ. Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged. Anesth Analg. 2003 Aug;97(2):534-540. doi: 10.1213/01.ANE.0000068822.10113.9E.

  PMID: 12873949 BACKGROUND

• Baliki MN, Mansour AR, Baria AT, Apkarian AV. Functional reorganization of the default mode network across chronic pain conditions. PLoS One. 2014 Sep 2;9(9):e106133. doi: 10.1371/journal.pone.0106133. eCollection 2014.

  PMID: 25180885 BACKGROUND

• Kucyi A, Salomons TV, Davis KD. Cognitive behavioral training reverses the effect of pain exposure on brain network activity. Pain. 2016 Sep;157(9):1895-1904. doi: 10.1097/j.pain.0000000000000592.

  PMID: 27101426 BACKGROUND

• Lamm C, Decety J, Singer T. Meta-analytic evidence for common and distinct neural networks associated with directly experienced pain and empathy for pain. Neuroimage. 2011 Feb 1;54(3):2492-502. doi: 10.1016/j.neuroimage.2010.10.014. Epub 2010 Oct 12.

  PMID: 20946964 BACKGROUND

• Vachon-Presseau E, Tetreault P, Petre B, Huang L, Berger SE, Torbey S, Baria AT, Mansour AR, Hashmi JA, Griffith JW, Comasco E, Schnitzer TJ, Baliki MN, Apkarian AV. Corticolimbic anatomical characteristics predetermine risk for chronic pain. Brain. 2016 Jul;139(Pt 7):1958-70. doi: 10.1093/brain/aww100. Epub 2016 May 5.

  PMID: 27190016 BACKGROUND

• Bernardy K, Klose P, Busch AJ, Choy EH, Hauser W. Cognitive behavioural therapies for fibromyalgia. Cochrane Database Syst Rev. 2013 Sep 10;2013(9):CD009796. doi: 10.1002/14651858.CD009796.pub2.

  PMID: 24018611 BACKGROUND

• Attal N, Masselin-Dubois A, Martinez V, Jayr C, Albi A, Fermanian J, Bouhassira D, Baudic S. Does cognitive functioning predict chronic pain? Results from a prospective surgical cohort. Brain. 2014 Mar;137(Pt 3):904-17. doi: 10.1093/brain/awt354. Epub 2014 Jan 17.

  PMID: 24441173 BACKGROUND

• Bowie CR, Harvey PD. Administration and interpretation of the Trail Making Test. Nat Protoc. 2006;1(5):2277-81. doi: 10.1038/nprot.2006.390.

  PMID: 17406468 BACKGROUND

• Crowe SF. The differential contribution of mental tracking, cognitive flexibility, visual search, and motor speed to performance on parts A and B of the Trail Making Test. J Clin Psychol. 1998 Aug;54(5):585-91. doi: 10.1002/(sici)1097-4679(199808)54:53.0.co;2-k.

  PMID: 9696108 BACKGROUND

• Kortte KB, Horner MD, Windham WK. The trail making test, part B: cognitive flexibility or ability to maintain set? Appl Neuropsychol. 2002;9(2):106-9. doi: 10.1207/S15324826AN0902_5.

  PMID: 12214820 BACKGROUND

• Sanchez-Cubillo I, Perianez JA, Adrover-Roig D, Rodriguez-Sanchez JM, Rios-Lago M, Tirapu J, Barcelo F. Construct validity of the Trail Making Test: role of task-switching, working memory, inhibition/interference control, and visuomotor abilities. J Int Neuropsychol Soc. 2009 May;15(3):438-50. doi: 10.1017/S1355617709090626.

  PMID: 19402930 BACKGROUND

• Uttl B, Graf P. Color-Word Stroop test performance across the adult life span. J Clin Exp Neuropsychol. 1997 Jun;19(3):405-20. doi: 10.1080/01688639708403869.

  PMID: 9268815 BACKGROUND

• Morrison GE, Simone CM, Ng NF, Hardy JL. Reliability and validity of the NeuroCognitive Performance Test, a web-based neuropsychological assessment. Front Psychol. 2015 Nov 3;6:1652. doi: 10.3389/fpsyg.2015.01652. eCollection 2015.

  PMID: 26579035 BACKGROUND

• Van Essen DC, Ugurbil K, Auerbach E, Barch D, Behrens TE, Bucholz R, Chang A, Chen L, Corbetta M, Curtiss SW, Della Penna S, Feinberg D, Glasser MF, Harel N, Heath AC, Larson-Prior L, Marcus D, Michalareas G, Moeller S, Oostenveld R, Petersen SE, Prior F, Schlaggar BL, Smith SM, Snyder AZ, Xu J, Yacoub E; WU-Minn HCP Consortium. The Human Connectome Project: a data acquisition perspective. Neuroimage. 2012 Oct 1;62(4):2222-31. doi: 10.1016/j.neuroimage.2012.02.018. Epub 2012 Feb 17.

  PMID: 22366334 BACKGROUND

• Glasser MF, Sotiropoulos SN, Wilson JA, Coalson TS, Fischl B, Andersson JL, Xu J, Jbabdi S, Webster M, Polimeni JR, Van Essen DC, Jenkinson M; WU-Minn HCP Consortium. The minimal preprocessing pipelines for the Human Connectome Project. Neuroimage. 2013 Oct 15;80:105-24. doi: 10.1016/j.neuroimage.2013.04.127. Epub 2013 May 11.

  PMID: 23668970 BACKGROUND

• Siegel JS, Mitra A, Laumann TO, Seitzman BA, Raichle M, Corbetta M, Snyder AZ. Data Quality Influences Observed Links Between Functional Connectivity and Behavior. Cereb Cortex. 2017 Sep 1;27(9):4492-4502. doi: 10.1093/cercor/bhw253.

  PMID: 27550863 BACKGROUND

• Glasser MF, Coalson TS, Robinson EC, Hacker CD, Harwell J, Yacoub E, Ugurbil K, Andersson J, Beckmann CF, Jenkinson M, Smith SM, Van Essen DC. A multi-modal parcellation of human cerebral cortex. Nature. 2016 Aug 11;536(7615):171-178. doi: 10.1038/nature18933. Epub 2016 Jul 20.

  PMID: 27437579 BACKGROUND

• Gordon EM, Laumann TO, Adeyemo B, Huckins JF, Kelley WM, Petersen SE. Generation and Evaluation of a Cortical Area Parcellation from Resting-State Correlations. Cereb Cortex. 2016 Jan;26(1):288-303. doi: 10.1093/cercor/bhu239. Epub 2014 Oct 14.

  PMID: 25316338 BACKGROUND

• Sporns O, Betzel RF. Modular Brain Networks. Annu Rev Psychol. 2016;67:613-40. doi: 10.1146/annurev-psych-122414-033634. Epub 2015 Sep 21.

  PMID: 26393868 BACKGROUND

• Porter S, Torres IJ, Panenka W, Rajwani Z, Fawcett D, Hyder A, Virji-Babul N. Changes in brain-behavior relationships following a 3-month pilot cognitive intervention program for adults with traumatic brain injury. Heliyon. 2017 Aug 4;3(8):e00373. doi: 10.1016/j.heliyon.2017.e00373. eCollection 2017 Aug.

  PMID: 28795168 BACKGROUND

• Sandroff BM, Wylie GR, Sutton BP, Johnson CL, DeLuca J, Motl RW. Treadmill walking exercise training and brain function in multiple sclerosis: Preliminary evidence setting the stage for a network-based approach to rehabilitation. Mult Scler J Exp Transl Clin. 2018 Feb 21;4(1):2055217318760641. doi: 10.1177/2055217318760641. eCollection 2018 Jan-Mar.

  PMID: 29497559 BACKGROUND

MeSH Terms

Conditions

Chronic Pain; Back Pain

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Simon Haroutounian, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthsiology

Study Record Dates

• First Submitted: October 10, 2018
• First Posted: October 25, 2018
• Study Start: July 16, 2019
• Primary Completion: June 30, 2021
• Study Completion: February 25, 2022
• Last Updated: April 13, 2022

Record last verified: 2022-04

Locations

US (1)