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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03720821
Acronym
COFLEX-i
Enrollment
46
Registered
2018-10-25
Start date
2019-07-16
Completion date
2022-02-25
Last updated
2022-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Detailed description

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.

Interventions

BEHAVIORALCognitive 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.

Sponsors

Washington University School of Medicine
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Changes in resting-state fMRI BOLD signal before and after 5 week cognitive training5 weeksChanges 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.

Secondary

MeasureTime frameDescription
Association between change in resting-state fMRI BOLD signal and the change in NCPT following cognitive training.5 weeksAssociation between change in resting state fMRI BOLD signal and the change in neurocognitive performance test (NCPT) score following 5 weeks of cognitive training.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026