NCT03720821|Completed
Cognitive Flexibility Training for Persistent Pain: Neuroimaging Pilot (COFLEX-i)
COFLEX-i
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COFLEX-i
Sponsor study identifier
interventional
46
1 country
1
Study Start
July 16, 2019
Actual (reported)Primary Completion
June 30, 2021
Actual (reported)Study Completion
February 25, 2022
Actual (reported)To determine whether a 5-week computer-based cognitive training intervention results in changes in resting-state functional connectivity (rsFC) within the brain networks.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 25, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 10, 2018
Actual (reported)October 25, 2018
Actual (reported)July 16, 2019
Actual (reported)June 30, 2021
Actual (reported)February 25, 2022
Actual (reported)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
Association between change in resting-state fMRI BOLD signal and the change in NCPT following cognitive training.
5 weeks
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Washington University in Saint Louis
St Louis, Missouri, 63110, United States
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.
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Simon Haroutounian, PhD
Washington University School of Medicine
46 participants (actual enrollment reported by the registry).
First Submitted
October 10, 2018
First Posted
October 25, 2018
Study Start
July 16, 2019
Actual (reported)Yoga for Chronic Low Back Pain in the Cleveland Clinic Employee Health Plan
Contact the study team to confirm eligibility.
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Primary Completion
June 30, 2021
Actual (reported)Study Completion
February 25, 2022
Actual (reported)Last Updated
April 13, 2022
Record last verified: 2022-04
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