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

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

Detailed Description
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This project is a single-center prospective pilot study to assess whether cognitive flexibility training through a Lumosity®-based training module over the course a five week timeframe in patients with chronic hip, knee, and back pain results in detectable changes in resting-state functional connectivity (rsFC). The investigators will explore changes in rsFC particularly within the default mode (DMN), frontoparietal (FPN), and cingulo-opercular (CON) brain networks.

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

Conditions
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Back Pain, Chronic Pain, Knee Pain Chronic, Hip Pain Chronic

Intervention / Treatment
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* Behavioral: Cognitive Training + fMRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Training + fMRI<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between change in resting-state fMRI BOLD signal and the change in NCPT following cognitive training. | Association between change in resting state fMRI BOLD signal and the change in neurocognitive performance test (NCPT) score following 5 weeks of cognitive training. | 5 weeks |