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Completed

NCT Number: NCT03720821

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

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

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Key information

Conditions

Chronic Pain Back Pain Hip Pain Chronic Knee Pain Chronic Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University in Saint Louis

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cognitive Training + fMRI

Behavioral

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.

Primary outcomes

  1. Changes in resting-state fMRI BOLD signal before and after 5 week cognitive training

    Time frame: 5 weeks

    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.

Secondary outcomes

  1. Association between change in resting-state fMRI BOLD signal and the change in NCPT following cognitive training.

    Time frame: 5 weeks

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

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Acronym: COFLEX-i

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Oct 25, 2018
Registry last updated
Apr 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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