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Clinical Trials/NCT04902339
NCT04902339
Completed
Not Applicable

Near-infrared Spectroscopy-based Neurofeedback as Adjunct to Mindfulness-Oriented Recovery Enhancement in Persons With Chronic Pain

University of Utah1 site in 1 country142 target enrollmentApril 3, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Pain Syndrome
Sponsor
University of Utah
Enrollment
142
Locations
1
Primary Endpoint
Blood oxygenation level dependent (BOLD) signaling
Status
Completed
Last Updated
last year

Overview

Brief Summary

The primary aim of this pilot trial is to enhance the efficacy of the Mindfulness-Oriented Recovery Enhancement (MORE) intervention by adding neurofeedback (NF) of the Orbitofrontal Cortex (OFC) as an adjunct to the savoring component of MORE. We hypothesize that the use of NF to train OFC responses during savoring will amplify patients' ability to savor and thereby increase brain responsivity to natural rewards; such enhanced reward responding will in turn be associated with improvements in clinical outcomes (e.g., pain, analgesic use).

Registry
clinicaltrials.gov
Start Date
April 3, 2021
End Date
April 3, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • ≥18 years of age,
  • ability to understand and speak the English language
  • current chronic pain-related diagnosis

Exclusion Criteria

  • mindfulness training experience (e.g., participation in MBSR/MBRP)
  • neurofeedback experience
  • current cancer diagnosis
  • having a psychiatric or medical condition that precludes the ability to provide informed consent or participation in outpatient treatment (e.g., psychosis, mania, acute intoxication)
  • suicidal ideation with a plan in the past week, or a suicide attempt in the past 3 months
  • unwilling, unable, or unlikely to complete study procedures (e.g., planned major surgery, anticipated move, travel barrier)
  • communication or cognitive impairment that limits participation in group treatment or study procedures

Outcomes

Primary Outcomes

Blood oxygenation level dependent (BOLD) signaling

Time Frame: From baseline to immediately after the intervention.

Changes in blood oxygenation levels to reward cues will be assessed, and planned comparisons will be performed between subjects receiving MORE+NF vs the control conditions.

Secondary Outcomes

  • Chronic pain symptoms(From baseline to 3-month follow-up.)
  • Pleasant sensation ratio(From baseline to immediately after intervention.)
  • Opioid misuse(From baseline to 3-month follow-up.)
  • Opioid dose(From baseline to 3-month follow-up.)
  • Savoring(From baseline to 3-month follow-up.)
  • Pleasure ratings(From baseline to immediately after intervention.)
  • Distress(From baseline to 3-month follow-up.)
  • Self-transcendence(From baseline to 3-month follow-up.)
  • Opioid craving(From baseline to 1-month follow-up.)
  • Positive affect(From baseline to 1-month follow-up.)

Study Sites (1)

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