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

Not Applicable

Completed

• Conditions: Chronic Pain; Hip Pain Chronic; Knee Pain Chronic; Back Pain
• Interventions: Behavioral: Cognitive Training + fMRI

• Registration Number: NCT03720821
• Lead Sponsor: Washington University School of Medicine

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.

Study Timeline

• Study First Submitted: 2018-10-10
• Study First Submitted QC: 2018-10-24
• Study First Posted: 2018-10-25
• Study Start: 2019-07-16
• Primary Completion: 2021-06-30
• Study Completion: 2022-02-25
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-12
• Last Update Posted: 2022-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cognitive Training + fMRI	Cognitive Training + fMRI	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.

Primary Outcome Measures

Name	Time	Method
Changes in resting-state fMRI BOLD signal before and after 5 week cognitive training	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 Outcome Measures

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

Trial Locations

Locations (1)

Washington University in Saint Louis; 🇺🇸 Saint Louis, Missouri, United States