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

Chronic Pain Clinical Trial

— COFLEX-i  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03720821
• Other study ID #: 201808143
• Status: Completed
• Phase: N/A
• Start date: July 16, 2019
• Est. completion date: February 25, 2022

Study information

• Verified date: April 2022
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: February 25, 2022
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Back Pain
• Chronic Pain
• Hip Pain Chronic
• Knee Pain Chronic

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Washington University in Saint Louis	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (27)

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* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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