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

N/ACompletedNCT03720821

Washington University School of Medicine46 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Chronic Pain Knee Pain Chronic Hip Pain Chronic Back Pain

Interventions

Cognitive Training + fMRIBEHAVIORAL

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

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Washington University in Saint Louis

St Louis, Missouri, United States

Outcomes

Primary Outcomes

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.

Time frame: 5 weeks

Secondary Outcomes

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.

Time frame: 5 weeks

Data from ClinicalTrials.gov

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