Cognitive Flexibility Training for Persistent Pain: Neuroimaging Pilot (COFLEX-i)
NCT ID: NCT03720821
Last Updated: 2022-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
46 participants
INTERVENTIONAL
2019-07-16
2022-02-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Cognitive Training + fMRI
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.
Cognitive Training + fMRI
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.
Interventions
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Cognitive Training + fMRI
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.
Eligibility Criteria
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Inclusion Criteria
* Documented moderate to severe chronic pain
* English fluency
* Access to a computer at home and an email account
Exclusion Criteria
* 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)
18 Years
70 Years
ALL
Yes
Sponsors
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Washington University School of Medicine
OTHER
Responsible Party
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simon.haroutounian
Assistant Professor of Anesthsiology
Principal Investigators
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Simon Haroutounian, PhD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University in Saint Louis
St Louis, Missouri, United States
Countries
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References
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Other Identifiers
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201808143
Identifier Type: -
Identifier Source: org_study_id
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